Effects of a carbohydrate-reduced high-protein diet delivered with meal kits to Danish people with type 2 diabetes: protocol for a 12-month randomised controlled trial.

INTRODUCTION: The cornerstone in the management of type 2 diabetes (T2D) is lifestyle modification including a healthy diet, typically one in which carbohydrate provides 45%-60% of total energy intake (E%). Nevertheless, systematic reviews and meta-analyses of trials with low carbohydrate diets (which are increased in protein and/or fat) for T2D have found improved glycaemic control in the first months relative to comparator diets with higher carbohydrate content. Studies lasting ≥1 year are inconclusive, which could be due to decreased long-term dietary adherence. We hypothesise that glucometabolic benefits can be achieved following 12 months of carbohydrate-restricted dieting, by maximising dietary adherence through delivery of meal kits, containing fresh, high-quality ingredients for breakfast, dinner and snacks, combined with nutrition education and counselling. METHODS AND ANALYSIS: This protocol describes a 12-month investigator-initiated randomised controlled, open-label, superiority trial with two parallel groups that will examine the effect of a carbohydrate-reduced high-protein (CRHP) diet compared with a conventional diabetes (CD) diet on glucometabolic control (change in glycated haemoglobin being the primary outcome) in 100 individuals with T2D and body mass index (BMI) >25 kg/m2. Participants will be randomised 1:1 to receive either the CRHP or the CD diet (comprised 30/50 E% from carbohydrate, 30/17 E% from protein and 40/33 E% from fat, respectively) for 12 months delivered as meal kits, containing foods covering more than two-thirds of the participants' estimated daily energy requirements for weight maintenance. Adherence to the allocated diets will be reinforced by monthly sessions of nutrition education and counselling from registered clinical dietitians. ETHICS AND DISSEMINATION: The trial has been approved by the National Committee on Health Research Ethics of the Capital Region of Denmark. The trial will be conducted in accordance with the Declaration of Helsinki. Results will be submitted for publication in international peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT05330247. PROTOCOL VERSION: The trial protocol was approved on 9 March 2022 (study number: H-21057605). The latest version of the protocol, described in this manuscript, was approved on 23 June 2023.

[Effects of high-fat and low-carbohydrate diet combined with radiotherapy on tumor microenvironment of Lewis lung cancer bearing mice].

Objective: To investigate the effect of high-fat and low-carbohydrate diet combined with radiotherapy on the tumor microenvironment of mice with lung xenografts. Methods: C57BL/6J mice were selected to establish the Lewis lung cancer model, and they were divided into the normal diet group, the high-fat and low-carbohydrate diet group, the normal diet + radiotherapy group, and the high-fat and low-carbohydrate diet + radiotherapy group, with 18 mice in each group. The mice in the normal diet group and the normal diet + radiotherapy group were fed with the normal diet with 12.11% fat for energy supply, and the mice in the high-fat and low-carbohydrate diet group and the high-fat and low-carbohydrate diet + radiotherapy group were fed with high-fat and low-carbohydratediet with 45.00% fat for energy. On the 12th to 14th days, the tumor sites of the mice in the normal diet + radiotherapy group and the high-fat and low-carbohydrate diet + radiotherapy group were treated with radiotherapy, and the irradiation dose was 24 Gy/3f. The body weight, tumor volume, blood glucose and blood ketone level, liver and kidney function, and survival status of the mice were observed and monitored. Immunohistochemical staining was used to detect the tumor-associated microangiogenesis molecule (CD34) and lymphatic endothelial hyaluronan receptor 1 (LYVE-1), Sirius staining was used to detect collagen fibers, and multiplex immunofluorescence was used to detect CD8 and programmed death-1 (PD-1). Expression of immune cell phenotypes (CD3, CD4, CD8, and Treg) was detected by flow cytometry. Results: On the 27th day after inoculation, the body weigh of the common diet group was(24.78±2.22)g, which was significantly higher than that of the common diet + radiotherapy group [(22.15±0.48)g, P=0.030] and high-fat low-carbohydrate diet + radiotherapy group [(22.02±0.77)g, P=0.031)]. On the 15th day after inoculation, the tumor volume of the high-fat and low-carbohydrate diet + radiotherapy group was (220.88±130.05) mm3, which was significantly smaller than that of the normal diet group [(504.37±328.48) mm3, P=0.042)] and the high-fat, low-carbohydrate diet group [(534.26±230.42) mm3, P=0.016], but there was no statistically significant difference compared with the normal diet + radiotherapy group [(274.64±160.97) mm3]. In the 4th week, the blood glucose values of the mice in the high-fat and low-carbohydrate diet group were lower than those in the normal diet group, with the value being (8.00±0.36) mmol/L and (9.57±0.40) mmol/L, respectively, and the difference was statistically significant (P＜0.05). The blood ketone values of the mice in the high-fat and low-carbohydrate diet group were higher than those in the normal diet group, with the value being (1.00±0.20) mmol/L and (0.63±0.06) mmol/L, respectively, in the second week. In the third week, the blood ketone values of the two groups of mice were (0.90±0.17) mmol/L and (0.70±0.10) mmol/L, respectively, and the difference was statistically significant (P＜0.05). On the 30th day after inoculation, there were no significant differences in aspartate aminotransferase, alanine aminotransferase, creatinine, and urea between the normal diet group and the high-fat, low-carbohydrate diet group (all P＞0.05). The hearts, livers, spleens, lungs, and kidneys of the mice in each group had no obvious toxic changes and tumor metastasis. In the high-fat and low-carbohydrate diet + radiotherapy group, the expression of CD8 was up-regulated in the tumor tissues of mice, and the expressions of PD-1, CD34, LYVE-1, and collagen fibers were down-regulated. The proportion of CD8+ T cells in the paratumoral lymph nodes of the high-fat and low-carbohydrate diet + radiotherapy group was (25.13±0.97)%, higher than that of the normal diet group [(20.60±2.23)%, P＜0.050] and the normal diet + radiotherapy group [(19.26±3.07)%, P＜0.05], but there was no statistically significant difference with the high-fat and low-carbohydrate diet group [(22.03±1.75)%, P＞0.05]. The proportion, of CD4+ T cells in the lymph nodes adjacent to the tumor in the normal diet + radiotherapy group (31.33±5.16)% and the high-fat and low-carbohydrate diet + radiotherapy group (30.63±1.70)% were higher than that in the normal diet group [(20.27±2.15)%, P＜0.05] and the high-fat and low-carbohydrate diet group (23.70±2.62, P＜0.05). Treg cells accounted for the highest (16.58±5.10)% of T cells in the para-tumor lymph nodes of the normal diet + radiotherapy group, but compared with the normal diet group, the high-fat and low-carbohydrate diet group, and the high-fat and low-carbohydrate diet + radiotherapy group, there was no statistically significant difference (all P＞0.05). Conclusion: High-fat and low-carbohydrate diet plus radiotherapy can enhance the recruitment and function of immune effector cells in the tumor microenvironment, inhibit tumor microangiogenesis, and thus inhibit tumor growth.

Effects of a Ketogenic Diet on Body Composition in Healthy, Young, Normal-Weight Women: A Randomized Controlled Feeding Trial.

This study investigates the effects of a ketogenic low-carbohydrate high-fat (LCHF) diet on body composition in healthy, young, normal-weight women. With the increasing interest in ketogenic diets for their various health benefits, this research aims to understand their impact on body composition, focusing on women who are often underrepresented in such studies. Conducting a randomized controlled feeding trial with a crossover design, this study compares a ketogenic LCHF diet to a Swedish National Food Agency (NFA)-recommended control diet over four weeks. Seventeen healthy, young, normal-weight women adhered strictly to the provided diets, with ketosis confirmed through blood ß-hydroxybutyrate concentrations. Dual-energy X-ray absorptiometry (DXA) was utilized for precise body composition measurements. To avoid bias, all statistical analyses were performed blind. The findings reveal that the ketogenic LCHF diet led to a significant reduction in both lean mass (-1.45 kg 95% CI: [-1.90;-1.00]; p < 0.001) and fat mass (-0.66 kg 95% CI: [-1.00;-0.32]; p < 0.001) compared to the control diet, despite similar energy intake and physical activity levels. This study concludes that while the ketogenic LCHF diet is effective for weight loss, it disproportionately reduces lean mass over fat mass, suggesting the need for concurrent strength training to mitigate muscle loss in women following this diet.

Effects of Short-Term Nighttime Carbohydrate Restriction Method on Exercise Performance and Fat Metabolism.

BACKGROUND: The sleep-low method has been proposed as a way to sleep in a low-glycogen state, increase the duration of low glycogen availability and sleep and temporarily restrict carbohydrates to improve exercise performance. However, long-term dietary restriction may induce mental stress in athletes. Therefore, if it can be shown that the effects of the sleep-low method can be achieved by restricting the carbohydrate intake at night (the nighttime carbohydrate restriction method), innovative methods could be developed to reduce weight in individuals with obesity and enhance athletes' performance with reduced stress and in a shorter duration when compared with those of previous studies. With this background, we conducted a study with the purpose of examining the intervention effects of a short-term intensive nighttime carbohydrate restriction method. METHODS: A total of 22 participants were recruited among university students participating in sports club activities. The participants were assigned at random to groups, including a nighttime carbohydrate restriction group of 11 participants (6 males, 5 females; age 22.3 ± 1.23) who started a carbohydrate-restricted diet and a group of 11 participants (5 males, 6 females; age 21.9 ± 7.9) who continued with their usual diet. The present study had a two-group parallel design. In the first week, no dietary restrictions were imposed on either group, and the participants consumed their own habitual diets. In the second week, the total amount of calories and carbohydrate intake measured in the first week were divided by seven days, and the average values were calculated. These were used as the daily calorie and carbohydrate intakes in the second week. Only the nighttime carbohydrate restriction group was prohibited from consuming carbohydrates after 4:00 p.m. During the two-week study period, all participants ran for one hour each day before breakfast at a heart rate of 65% of their maximum heart rate. RESULTS: The results obtained from young adults participating in sports showed significant differences in peak oxygen consumption (V·O2peak), work rate max, respiratory quotient (RQ), body weight and lean body mass after the intervention when compared with before the intervention in the nighttime carbohydrate restriction group (p < 0.05). CONCLUSIONS: Our findings suggest that the nighttime carbohydrate restriction method markedly improves fat metabolism even when performed for a short period. This method can be used to reduce body weight in individuals with obesity and enhance athletes' performance. However, it is important to consider the intake of nutrition other than carbohydrates.

A Mobile-Based Nutrition Tracker App Enhanced Dietitian-Guided 2:1:1 Diet-Induced Weight Loss: An 8-Week Retrospective Cohort Study in Taiwan.

Effective weight management interventions involve a combination of behavioral strategies focusing on dietary changes. Tracing the change through mobile apps has been proven to be a valuable platform for facilitating weight management in many countries. However, the effectiveness of mobile app-based dietary intervention on weight management in Taiwan remains to be determined. By using the designated mobile app, this study aimed to assess the efficacy of the diet intervention, which is based on a 2:1:1 portion control plate and a flexible low-carbohydrate (FLC) diet. This 8-week retrospective cohort study involved 10,297 participants who were divided into two groups: the intervention group (joined an 8-week diet intervention program with the daily diet record assessed by registered dietitians) and the control group (voluntarily using the app without instructional materials or coaching). After eight weeks of intervention, the intervention group showed a higher weight loss percentage (-4.78% vs. -1.54%), body mass index (BMI) (-1.26 kg/m2 vs. 0.69 kg/m2), and diet record completeness (73.52% vs. 28.91%) compared with the control group. With respect to gender, male participants showed higher baseline weight and higher weight loss (-6.02%) in the intervention group. In the intervention group, 2871 participants (33.4%) lost less than 4% of their weight, 5071 participants (58.9%) lost 4-8% of their body weight, and 662 participants (7.7%) lost >8% of their weight. Compared to the low-effectiveness group (weight lost <4%), the high-effectiveness group (weight lost >8%) had a significantly higher diet record completeness (91.61 ± 15.99 vs. 55.81 ± 32.92), dietary compliance (green light %) (88.93 ± 9.9 vs. 77.75 ±17.5), protein intake % (26.34 ± 2.85 vs. 23.49 ± 3.56), and fat intake % (49.66 ± 6.36 vs. 44.05 ± 7.37). Most importantly, the high-effectiveness group had a lower carbohydrate intake % (24.1 ± 7.86 vs. 32.46 ± 9.61). The results remained significant after being stratified by gender. This study found that the use of online applications plus the intervention of dietitians is beneficial for short-term weight loss. The composition of nutrients and dietary compliance also significantly impacted weight loss.

Is There an Ideal Diet? Some Insights from the POUNDS Lost Study.

Diets for weight loss have a long history but an ideal one has not yet been clearly identified. To compare low-fat and lower carbohydrate diets, we designed The Preventing Overweight by Novel Dietary Strategies (POUNDS) Lost study. This is a 2 × 2 factorial study with diets of 20% or 40% fat and 15% or 25% protein with a graded carbohydrate intake of 35, 45, 55 and 65%. Weight loss, overall, was modest at nearly 6% with all four diets, and no significant dietary difference. The variability in weight loss in each diet group was significant, ranging from greater than 20% to a small weight gain. Studies of genetic variations in relation to weight loss showed that the diet that was selected could significantly affect weight loss, emphasizing that there is no ideal diet and more than one diet can be used to treat obesity. Weight loss was also influenced by the level of baseline triiodothyronine or thyroxine, and baseline carbohydrate and insulin resistance. Achieving a stable Health Eating Food Diversity Index, eating more protein, eating more fiber, engaging in more physical activity, sleeping better and eating less ultra-processed foods were beneficial strategies for weight loss in this trial. Although there is no "ideal diet", both the DASH diet and the Mediterranean diet have clinical trials showing their significant benefit for cardiovascular risk factors. Finally, the lesson of the "Last Chance Diet", which recommended a diet with protein from gelatin, proved that some diets could be hazardous.

Is the Mediterranean Low Fodmap Diet Effective in Managing Irritable Bowel Syndrome Symptoms and Gut Microbiota? An Innovative Research Protocol.

INTRODUCTION: Irritable bowel syndrome (IBS) symptoms can be effectively managed with the low FODMAP diet. However, its efficacy in reducing inflammation is not yet proven. On the contrary, the Mediterranean diet has anti-inflammatory properties with proven efficacy in treating chronic low-grade inflammation-related diseases. AIM: To publicly share our protocol evaluating the efficacy of the Mediterranean low-FODMAP (MED-LFD) versus NICE recommendations (British National Institute for Health and Care Excellence) diet in managing IBS symptoms and quality of life. MATERIALS AND METHODS: Participants meeting the Rome IV criteria will be randomly assigned to MED-LFD or NICE recommendations and they will be followed for six months. Efficacy, symptom relief, quality of life and mental health will be assessed using validated questionnaires. In addition, fecal samples will be analyzed to assess gut microbiota, and to measure branched and short-chain fatty acids, and volatile organic compounds (metabolic byproducts from bacteria). Expected results and discussion: By publicly sharing this clinical study protocol, we aim to improve research quality in the field of IBS management by allowing for peer review feedback, preventing data manipulation, reducing redundant research efforts, mitigating publication bias, and empowering patient decision-making. We expect that this protocol will show that MED-LFD can effectively alleviate IBS symptoms and it will provide pathophysiology insights on its efficacy. The new dietary pattern that combines the LFD and the MED approaches allows for the observation of the synergistic action of both diets, with the MED's anti-inflammatory and prebiotic properties enhancing the effects of the LFD while minimizing its limitations. Identifier in Clinical Trials: NCT03997708.

Eight Weeks of Intermittent Exercise in Hypoxia, with or without a Low-Carbohydrate Diet, Improves Bone Mass and Functional and Physiological Capacity in Older Adults with Type 2 Diabetes.

In an increasingly aging and overweight population, osteoporosis and type 2 diabetes (T2DM) are major public health concerns. T2DM patients experience prejudicial effects on their bone health, affecting their physical capacity. Exercise in hypoxia (EH) and a low-carbohydrate diet (LCD) have been suggested for therapeutic benefits in T2DM, improving bone mineral content (BMC) and glycemic control. This study investigated the effects of EH combined with an LCD on body composition and functional and physiologic capacity in T2DM patients. Older T2DM patients (n = 42) were randomly assigned to the following groups: (1) control group: control diet + exercise in normoxia; (2) EH group: control diet + EH; (3) intervention group: LCD + EH. Cardiopulmonary tests (BRUCE protocol), body composition (DEXA), and functional capacity (6MWT, handgrip strength) were evaluated. Body mass index (kg/m2) and body fat (%) decreased in all groups (p < 0.001). BMC (kg) increased in all groups (p < 0.001) and was significantly higher in the EH and EH + LCD groups (p < 0.001). VO2peak improved in all groups (p < 0.001), but more so in the hypoxia groups (p = 0.019). Functional capacity was increased in all groups (p < 0.001), but more so in the EH group in 6MWT (p = 0.030). EH with and without an LCD is a therapeutic strategy for improving bone mass in T2DM, which is associated with cardiorespiratory and functional improvements.

Dietary Survey of Japanese Individuals with Type 2 Diabetes Mellitus on a Low-Carbohydrate Diet: An Observational Study.

The nutrient intake of persons with diabetes placed on a low-carbohydrate diet remains unclear. This study aimed to assess nutrient intake in persons with type 2 diabetes mellitus treated with a low-carbohydrate diet. The brief-type self-administered diet history questionnaire was used to collect the dietary information of 335 outpatients at Kitasato Institute Hospital, while their clinical characteristics were collected from their electronic medical records. The median age, HbA1c level, and body mass index of the participants were 68 (60-74) years, 49 (45-55) mmol/mol [6.7 (6.3-7.2)%], and 24.0 (21.8-26.7) kg/m2, respectively; median energy intake was 1457 (1153-1786) kcal/day; and protein-energy, fat-energy, and available carbohydrate-energy ratios were 18.6 (15.7-21.4)%E, 36.8 (31.6-43.2)%E, and 34.6 (26.0-42.4)%E, respectively. As the available carbohydrate-energy ratio decreased, the fat-energy ratio increased significantly. The total dietary fibre and salt intake were 7.1 (5.6-8.4) g/1000 kcal and 6.5 (5.6-7.5) g/1000 kcal, respectively. Japanese individuals with type 2 diabetes mellitus placed on a low-carbohydrate diet had a fat-to-energy ratio exceeding 30%, while the fat-energy ratio increased as the carbohydrate-energy ratio decreased.

Dietetic Management of Irritable Bowel Syndrome: A National Survey of Dietary Approaches and Decision-making Factors.

BACKGROUND AND AIMS: There has been a growing emphasis on dietary therapies for irritable bowel syndrome (IBS). Furthermore, there has been an evolving evidence base for the low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet, gluten-free diet (GFD), and lactose-free diet. This study examines the dietary approaches employed and the factors influencing dietetic decision-making for IBS interventions. METHODS: Participants, including registered dietitians and nutritionists, were recruited from diverse healthcare settings at the point of registration for the 4th Sheffield National Dietetic Gastroenterology Symposium, 2023. A 15-question online survey investigated the practices of dietitians and nutritionists in managing IBS patients, covering dietary approaches, decision-making factors, and patient education. The evidence base for different dietary interventions was provided and a follow-up survey assessed symposium attendees, views on current IBS dietary practices. RESULTS: Out of 731 respondents, primarily registered dietitians (93%) and females (93%), 54% spent 10-50% of clinic time on IBS. Respondents noted that a GFD (34%), low lactose (32%), and traditional dietary advice (TDA) (18%) were the most frequently used dietary interventions that patients try before seeking professional advice. Delegates were asked to rank their dietary intervention preferences pre- and post-meeting (after the evidence base had been presented): TDA pre-meeting 75% versus post-meeting 87% (p=0.04), fibre modification 59% versus 6% (p<0.0001), low FODMAP 25% versus 10% (p=0.0001), low lactose 12% versus 62% (p<0.0001) and GFD 6% to 23% (p<0.0001). CONCLUSIONS: TDA remains the choice of diet for dietitians. After our educational event, the use of low-lactose and gluten-free diet significantly increased. Factors influencing the decision-making process were based on patient acceptability, counselling time, supporting evidence base and dietary triggers.

A diet low in fermentable oligo-, di-, monosaccharides and polyols improves abdominal and overall symptoms in persons with all subtypes of irritable bowel syndrome.

BACKGROUND: A diet low in fermentable oligo-, di-, monosaccharides and polyols (LFD) improves symptoms in patients with irritable bowel syndrome (IBS). Previous studies have focused on patients with IBS and diarrhea (IBS-D). It is unclear whether LFD is effective for IBS with constipation (IBS-C) or IBS with mixed bowel habits (IBS-M). This open-label, real-world study evaluates the relative effectiveness of the LFD among IBS subtypes. METHODS: This study analyzes data from a service that provides low-FODMAP meals to individuals with IBS. Participants met with a registered dietitian and completed the IBS symptom severity survey (IBS-SSS) before and after undergoing a 2-4-week period of FODMAP restriction. The primary endpoint was the proportion of participants with ≥50-point decrease in IBS-SSS between the three IBS subtypes. KEY RESULTS: After FODMAP restriction, 90% of participants with IBS-D, 75% with IBS-C, and 84% with IBS-M met the primary endpoint (p = 0.045). Similar improvement was seen for a 100-point decrease, but the difference between IBS subtypes was not significant (p = 0.46). After FODMAP restriction, all groups had statistically significant improvement in total IBS-SSS as well as individual symptom categories. Improvement in IBS-SSS subcategories was similar among the groups except for the categories of bloating severity (IBS-M had greatest improvement) and bowel movement satisfaction (IBS-C had less improvement). CONCLUSION & INFERENCES: Though the proportion of responders was highest for IBS-D and lowest for IBS-C, the LFD led to robust improvement in overall symptoms in all IBS subtypes. Key individual symptoms also showed significant improvements in all IBS subtypes.

Potential therapeutic effect of a ketogenic diet for the treatment of lymphoedema: Results of an exploratory study.

BACKGROUND: Lymphoedema is a chronic and progressive disease characterised by excessive accumulation of lymph in the interstitial compartment, leading to tissue swelling and fibroadipose deposition. Lymphangiogenesis is partly regulated by ketone body oxidation, and a ketogenic diet (KD) has shown therapeutic efficacy in a preclinical mouse tail lymphoedema model. Therefore, we aimed to investigate the potential therapeutic effect of a KD in patients with secondary lymphoedema. METHODS: Nine patients with unilateral stage 2 lymphoedema secondary to lymphadenectomy were included in this quasi-experimental exploratory study consisting of a short run-in phase to gradually induce ketosis, followed by a classic KD (CKD) and modified Atkins diet (MAD) phase during which patients consumed a CKD and MAD, respectively. Lymphatic function and oedema volume, the primary outcomes, were assessed at baseline and at the end of both the CKD and MAD phase. Secondary outcomes included health-related and lymphedema-specific quality of life (QoL). RESULTS: Seven out of nine patients completed the study protocol. Lymphatic function was improved upon consumption of both a CKD (dermal backflow score [mean ± SD]: 7.29 ± 2.98 vs. 10.86 ± 2.19 at baseline; p = 0.03) and MAD (6.71 ± 2.06; p = 0.02), whereas oedema volume did not decrease during the course of the study (excess limb volume [mean ± SD]: 20.13 ± 10.25% at end of CKD and 24.07 ± 17.77% at end of MAD vs. 20.79 ± 12.96% at baseline; p > 0.99 and p > 0.30, respectively). No changes were observed in health-related, nor lymphoedema-specific QoL at the end of CKD and MAD. CONCLUSIONS: The consumption of a KD improved lymphatic function and was associated with a clinically meaningful reduction in oedema volume in some patients (3/7 at end of CKD, 2/7 at end of MAD) with unilateral stage 2 secondary lymphoedema. These results highlight the potential of a KD to improve lymphatic function in patients with lymphoedema. However, further studies are required to substantiate our findings.

The low-FODMAP diet.

In this article we present a protocol for the use of the low-FODMAP diet in paediatric patients and review of the current evidence on its efficacy. These short-chain carbohydrates, which can be fermented by the intestinal microbiota, are found in a wide variety of foods, mainly of plant origin. The low-FODMAP diet is a therapeutic tool used for the management of gastrointestinal disorders such as irritable bowel syndrome. The sources we used were PubMed, Web of Science, Google Scholar and institutional websites. Following consumption of FODMAP-rich foods, a series of end products are generated that are not absorbed, giving rise to symptoms. Before starting a low-FODMAP diet, it is important to carry out a diagnostic evaluation including any applicable tests. Treatment is structured in 3 phases: elimination, reintroduction and personalization phase. In the first phase, FODMAP-rich foods are eliminated for 2-3 weeks. In the second phase, lasting 8 weeks, FODMAP-rich foods are gradually reintroduced. The last phase consists in customizing the diet according to individual tolerance. This article details which foods contain FODMAPs and possible substitutes. In addition, specific food diary/intake tracking and educational materials are provided in a series of appendices to facilitate adherence to the diet. Although most studies have been conducted in adults, there is also some evidence on the beneficial effects in the paediatric age group, with a reduction of symptoms, especially in patients with functional gastrointestinal disorders. Nevertheless, more research is required on the subject.

A randomized controlled trial of a weight loss maintenance program in adults with obesity: the WLM3P study.

BACKGROUND/OBJECTIVES: The escalating obesity epidemic necessitates effective, sustainable weight loss (WL) and maintenance strategies. This study aimed to evaluate the effectiveness of the Weight Loss Maintenance 3 Phases Program (WLM3P) in achieving a clinically significant long-term weight loss (WL) (≥5% initial WL at 18 months) in adults with obesity compared to a standard low-carbohydrate diet (LCD). SUBJECTS/METHODS: In this two-phase trial, 112 participants targeting initial WL (0-6 months) and subsequent maintenance (7-18 months) were randomly assigned to either WLM3P or LCD groups. Outcomes assessed included change in body weight (kg, %), improvements in body composition, and metabolic profile. RESULTS: Of 112 randomized participants, 69% (n = 77) completed the study. At 18 months, WL in the WLM3P group (n = 40) was 15.5 ± 8.3% compared to 9.6 ± 8.5% in the LCD group (n = 37) (p < 0.001). The odds ratio of achieving WL ≥ 10% and ≥15% were significantly higher in the WLM3P group. Complete-case analysis revealed significantly greater improvements in BMI, body fat mass, visceral fat area, waist circumference, waist-to-hip ratio, HDL, and triglyceride/HDL ratio in WLM3P than in LCD. No serious adverse events were reported. CONCLUSION: Both programs effectively promoted clinically relevant WL and its maintenance. However, the WLM3P program was more successful in helping participants achieve greater WL targets of ≥10% and ≥15%, along with other clinical benefits, after an 18-month intervention. TRIAL REGISTRATION NUMBER: NCT04192357.

Effects of basic carbohydrate counting versus standard dietary care for glycaemic control in type 2 diabetes (The BCC Study): a randomised, controlled trial.

BACKGROUND: Clinical guidelines recommend basic carbohydrate counting (BCC), or similar methods to improve carbohydrate estimation skills and to strive for higher consistency in carbohydrate intake potentially improving glycaemic control. However, evidence for this approach in type 2 diabetes (T2D) is limited. OBJECTIVE: To examine the efficacy of a structured education program in BCC as add-on to standard dietary care on glycaemic control in individuals with T2D. METHODS: The BCC Study was a randomized, controlled, open-label, parallel-group trial. Individuals with T2D aged 18-75 years with glycated haemoglobin A1c (HbA1c) 53-97 mmol/mol (7.0-11.0%) were randomly assigned (1:1) to BCC or standard dietary care. The primary outcomes were differences in changes in HbA1c or glycaemic variability (calculated as mean amplitude of glycaemic excursions [MAGE]) between groups after six months of intervention. RESULTS: Between September 2018 and July 2021, 48 participants were randomly assigned, 23 to BCC and 25 to standard dietary care. Seven participants did not receive the allocated intervention. From a baseline-adjusted mean of 65 mmol/mol (95% CI 62-68 [8.1%, 7.8-8.4]), HbA1c changed by -5 mmol/mol (-8 to -1 [-0.5%, -0.7 to -0.1]) in BCC and -3 mmol/mol (-7 to 1 [-0.3%, -0.6 to 0.1]) in standard care with an estimated treatment effect of -2 mmol/mol (-7 to 4 [-0.2%, -0.6 to 0.4]); p = 0.554. From a baseline-adjusted mean of 4.2 mmol/l (3.7 to 4.8), MAGE changed by -16% (-33 to 5) in BCC and by -3% (-21 to 20) in standard care with an estimated treatment effect of -14% (-36 to 16); p = 0.319. Only median carbohydrate estimation error in favour of BCC (estimated treatment difference -55% (-70 to -32); p < 0.001) remained significant after multiple testing adjustment. CONCLUSIONS: No glycaemic effects were found but incorporating BCC as a supplementary component to standard dietary care led to improved skills in estimating carbohydrate intake among individuals with T2D.

Global research trend and hotspot in the low FODMAP diet: a bibliometric analysis.

BACKGROUND: According to national guidelines, a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) is a second-line therapy option for irritable bowel syndrome (IBS) and improves functional intestinal symptoms. Numerous noteworthy results have been published in this field over the past fifteen years. This study aims to analyze the global research trend and hotspot of the low FODMAP diet research, and provide a comprehensive perspective and direction for researchers. METHODS: The Science Citation Index-Expanded of the Web of Science Core Collection (WoSCC) was used to identify low FODMAP diet-related articles and reviews. Three bibliometric programs (CiteSpace, VOSviewer, Scimago Graphic) were utilized to analyze and visualize the annual publications, authors, countries, institutions, journals, citations, and keywords. RESULTS: In total, 843 documents related to the low FODMAP diet research were published in 227 journals by 3,343 authors in 1,233 institutions from 59 countries. The United States, which was the most engaged nation in international collaboration, had the largest annual production and the fastest growth. The most productive organization was Monash University, and the most fruitful researcher was Gibson PR. Nutrients ranked first in terms of the number of published documents. The article "A diet low in FODMAPs reduces symptoms of irritable bowel syndrome" (Halmos EP, 2014) received the most co-citations. Keywords that appear frequently in the literature mainly involve two main aspects: the clinical efficacy evaluation and mechanism exploration of the low FODMAP diet. The term "gut microbiota" stands out as the most prominent keyword among the burst keywords that have remained prevalent till date. CONCLUSION: The restriction stage of the low FODMAP diet is superior to other dietary therapies for IBS in terms of symptom response, but it has a negative impact on the abundance of gut Bifidobacteria and diet quality. Identification of biomarkers to predict response to the low FODMAP diet is of great interest and has become the current research hotspot.

Effects of a low FODMAP diet on the symptom management of patients with irritable bowel syndrome: a systematic umbrella review with the meta-analysis of clinical trials.

A low FODMAP diet (LFD) is a common restrictive diet to manage the symptoms of irritable bowel syndrome (IBS). However, there is no consensus on the alleviating effects of this diet. Herein, a systematic umbrella review with meta-analysis was conducted to investigate the effect of an LFD on IBS symptoms and its secondary outcomes in patients, which were not reported in previous meta-analyses. We performed a systematic literature search in PubMed, Scopus, and ISI Web of Science up to December 2023. The methodological quality of systematic reviews and their included trials was evaluated using AMSTAR 2 and the Cochrane risk of bias, respectively. The certainty of the evidence tool was evaluated using the GRADE approach. The data related to IBS symptoms, quality of life (QoL), microbiome diversity, and stool short-chain fatty acids were extracted. A random-effect (if RCTs ≥ 6) or fixed-effect model (if RCTs < 5) was used to recalculate effect sizes and 95% CIs and report them in both qualitative and quantitative terms (pooled risk ratio, Hedges' g, and weighted mean difference). A total of 658 articles were initially identified, with 11 meta-analyses and 24 RCTs reporting 28 outcomes with 1646 participants included. An LFD significantly affected the clinical improvement of total symptoms according to the IBS-SSS questionnaire (RR: 1.42; 95% CI: 1.02, 1.97; P = 0.04) in all the subtypes of IBS and also had favorable effects on stool consistency (WMD: -0.48; 95% CI: -0.902, -0.07) and frequency (WMD: -0.36; 95% CI: -0.61, -0.10) and some other GI symptoms in both less and more than 4 weeks of diet intervention except for stool consistency, which needed more than 4 weeks of LFD implementation. A significant QoL improvement was observed but not in the anxiety and depression state. Furthermore, some studies showed that an LFD may increase fecal pH and dysbiosis and reduce SCFA and the abundance of Bifidobacterium. In conclusion, an LFD can alleviate symptoms and QoL in IBS patients, although dysbiosis may occur. Considering the low certainty of evidence, strong RCTs with more appropriate designs are needed.

The efficacy and real-world effectiveness of a diet low in fermentable oligo-, di-, monosaccharides and polyols in irritable bowel syndrome: A systematic review and meta-analysis.

BACKGROUND & AIMS: A diet low in fermentable oligo-, di-, monosaccharides, and polyols (LFD) has been shown to effectively reduce irritable bowel syndrome (IBS) symptoms. Effects resulting from real-world studies may differ from those seen in efficacy studies because of the diversity of patients in real-world settings. This systematic review and meta-analysis aimed to compare the effect of the LFD on reducing IBS symptoms and improving the quality of life (QoL) in efficacy trials and real-world studies. METHODS: Major databases, trial registries, dissertations, and journals were systematically searched for studies on the LFD in adults with IBS. Meta-analysis was conducted using a random effects model with standardized mean differences (SMD) and 95% confidence intervals (CI). Outcomes of interest were all patient-reported: stool consistency, stool frequency, abdominal pain, overall symptoms, adequate symptom relief, IBS-specific QoL and adherence to the LFD. RESULTS: Eleven efficacy and 19 real-world studies were reviewed. The meta-analysis results for abdominal pain (SMD 0.35, 95% CI 0.16 to 0.54) and QoL (SMD 0.23, 95% CI -0.05 to 0.50) showed the LFD was beneficial in efficacy studies with no statistically significant results for stool frequency (SMD 0.71, 95% CI 0.34 to 1.07). Real-world studies found improvements in abdominal pain and QoL. Due to heterogeneity, no meta-analysis was done for stool consistency and overall symptoms. In these outcomes, results were mostly supportive of the LFD, but they were not always statistically significant. CONCLUSIONS: The results of this systematic review and meta-analysis suggest the LFD improves outcomes compared to a control diet (efficacy studies) or baseline data (real-world studies). Because of diverse study designs and heterogeneity of results, a clear superiority of the LFD over control diets could not be concluded. There are no indications of an efficacy-effectiveness gap for the LFD in adults with IBS.

Beyond Obesity and Overweight: The Clinical Assessment and Treatment of Excess Body Fat in Children : Part 1 - Insulin Resistance as the Root Cause of Pediatric Obesity.

PURPOSE OF REVIEW: Pediatric obesity and comorbidities related to insulin resistance continue to be a growing public health crisis. If lifestyle measures are unsuccessful, pharmacological and surgical interventions are offered. In this paper, we describe the driving force of the obesity crisis: hyperinsulinemia and the development of insulin resistance. We give historical background of key policy issues which have contributed to this pandemic as well as the physiologic mechanisms of insulin resistance. The prevalence of obesity will continue to rise unless the root cause of hyperinsulinemia is addressed. RECENT FINDINGS: Current research on insulin resistance demonstrates that a decreased consumption of carbohydrates is an effective first-line dietary intervention for the treatment of obesity and related metabolic diseases. Evidence shows it is safe and beneficial. A low-carbohydrate eating pattern can be helpful to address pediatric obesity. However, there must be policy guardrails in place to ensure that this is a sustainable and viable option for children and their families. There must be a change in the nutritional environment to help individuals battle the chronic disease of obesity.

Nutritional safety and status following a 12-week strict low FODMAP diet in patients with irritable bowel syndrome.

BACKGROUND: A low FODMAP diet (LFD) is an established dietary treatment for patients with irritable bowel syndrome (IBS). However, knowledge on the extended effects of the restriction phase regarding nutrient intake, symptom severity, and quality of life (QoL) is sparse. Therefore, our objectives were to evaluate the safety of a dietitian-led 12-week strict LFD on measures of blood biochemistry, nutritional status, symptom severity, and QoL. METHODS: In this open-label dietitian-led 12-week strict LFD intervention for IBS patients with predominantly diarrhea or mixed stool pattern (IBS-D/-M), we collected data on diet intake (3-day dietary record), overnight fasting routine blood samples, body weight, IBS symptoms (IBS Severity Scoring System (IBS-SSS)), and IBS-related QoL (IBS-QoL) at baseline and after 12 weeks. KEY RESULTS: Thirty-six participants completed the 12-week follow-up (mean age: 37 years, 67% women, IBS-SSS: 242 (101)). All blood parameters measured were within established reference values at both time points. We found no change in intake of macro- or micronutrients, but several micronutrients were below the recommendations both before and after 12 weeks. BMI slightly decreased, primarily driven by participants with BMI >25 (p < 0.005). QoL improved among most subdomains (p ≤ 0.002), except food avoidance and social reaction. CONCLUSION: An extended dietitian-guided LFD (12 weeks) is not inferior to the participants' baseline diet, since no clinically meaningful changes in nutritionally related blood samples and no changes in macro- or micronutrient intake were observed. However, the intake of several nutrients was below the recommendations at both time points indicating low diet quality.