Reporting completeness of nutrition and diet-related randomised controlled trials protocols.

BACKGROUND AND AIMS: There is a need to consolidate reporting guidance for nutrition randomised controlled trial (RCT) protocols. The reporting completeness in nutrition RCT protocols and study characteristics associated with adherence to SPIRIT and TIDieR reporting guidelines are unknown. We, therefore, assessed reporting completeness and its potential predictors in a random sample of published nutrition and diet-related RCT protocols. METHODS: We conducted a meta-research study of 200 nutrition and diet-related RCT protocols published in 2019 and 2021 (aiming to consider periods before and after the start of the COVID pandemic). Data extraction included bibliometric information, general study characteristics, compliance with 122 questions corresponding to items and subitems in the SPIRIT and TIDieR checklists combined, and mention to these reporting guidelines in the publications. We calculated the proportion of protocols reporting each item and the frequency of items reported for each protocol. We investigated associations between selected publication aspects and reporting completeness using linear regression analysis. RESULTS: The majority of protocols included adults and elderly as their study population (n = 73; 36.5%), supplementation as intervention (n = 96; 48.0%), placebo as comparator (n = 89; 44.5%), and evaluated clinical status as the outcome (n = 80; 40.0%). Most protocols described a parallel RCT (n = 188; 94.0%) with a superiority framework (n = 141; 70.5%). Overall reporting completeness was 52.0% (SD = 10.8%). Adherence to SPIRIT items ranged from 0% (n = 0) (data collection methods) to 98.5% (n = 197) (eligibility criteria). Adherence to TIDieR items ranged from 5.5% (n = 11) (materials used in the intervention) to 98.5% (n = 197) (description of the intervention). The multivariable regression analysis suggests that a higher number of authors [ß = 0.53 (95%CI: 0.28-0.78)], most recent published protocols [ß = 3.19 (95%CI: 0.24-6.14)], request of reporting guideline checklist during the submission process by the journal [ß = 6.50 (95%CI: 2.56-10.43)] and mention of SPIRIT by the authors [ß = 5.15 (95%CI: 2.44-7.86)] are related to higher reporting completeness scores. CONCLUSIONS: Reporting completeness in a random sample of 200 diet or nutrition-related RCT protocols was low. Number of authors, year of publication, self-reported adherence to SPIRIT, and journals' endorsement of reporting guidelines seem to be positively associated with reporting completeness in nutrition and diet-related RCT protocols.

Sex differences in systemic inflammation and immune function in diet-induced obesity rodent models: A systematic review.

Understanding sex differences in immunological responses in the context of obesity is important to improve health outcomes. This systematic review aimed to investigate sex differences in systemic inflammation, immune cell phenotype, and function in diet-induced obesity (DIO) animal models. A systematic search in Medline, Embase, and CINAHL from inception to April 2023 was conducted, using a combination of the following concepts: sex, obesity, cytokines, and immune cell phenotypes/function. Forty-one publications reporting on systemic inflammation (61%), cell phenotype (44%), and/or function (7%) were included. Females had lower systemic inflammation compared with males in response to DIO intervention and a higher proportion of macrophage (M)2-like cells compared with males that had a higher proportion of M1-like in adipose tissue. Although there were no clear sex differences in immune function, high-fat DIO intervention remains an important factor in the development of immune dysfunction in both males and females, including disturbances in cytokine production, proliferation, and migration of immune cells. Yet, the mechanistic links between diet and obesity on such immune dysfunction remain unclear. Future studies should investigate the role of diet and obesity in the functionality of immune cells and employ adequate methods for a high-quality investigation of sex differences in this context.

Corrigendum: The nutrition and immunity (nutrIMM) study: protocol for a non-randomized, four-arm parallel-group, controlled feeding trial investigating immune function in obesity and type 2 diabetes.

[This corrects the article DOI: 10.3389/fnut.2023.1243359.].

The nutrition and immunity (nutrIMM) study: protocol for a non-randomized, four-arm parallel-group, controlled feeding trial investigating immune function in obesity and type 2 diabetes.

Introduction: Individuals with obesity and/or type 2 diabetes are at higher risk of infection and have worse prognoses compared to healthy individuals. Several factors may influence immune responses in this population, including high adiposity, hyperglycemia, and unhealthy dietary habits. However, there is insufficient data on the independent or clustered contribution of these factors to obesity-related immune dysfunction, especially accounting for dietary intake. This study aims to establish the independent contribution of obesity and hyperglycemia to immune dysfunction independent of diet in adults with and without obesity with or without type 2 diabetes. Methods: The Nutrition and Immunity (nutrIMM) study is a single-centre, non-randomized, four-arm, parallel-group, controlled feeding trial. It will enroll adults without obesity (Lean-NG) and with obesity and three metabolic phenotypes of normoglycemia, glucose intolerance, and type 2 diabetes. Participants will be assigned to one of four groups and will consume a standard North American-type diet for 4 weeks. The primary outcomes are plasma concentration of C-reactive protein and concentration of ex-vivo interleukin-2 secreted upon stimulation of T cells with phytohemagglutinin. Discussion: This will be the first controlled feeding study examining the contribution of obesity, hyperglycemia, and diet on systemic inflammation, immune cell phenotype, and function in adults of both sexes. Results of this clinical trial can ultimately be used to develop personalized dietary strategies to optimize immune function in individuals with obesity with different immune and metabolic profiles. Clinical trial registration: ClinicalTrials.gov, identifier NCT04291391.

Ginger supplementation does not increase energy expenditure in female adults.

Food components with thermogenic properties are promising antiobesity agents. Ginger (Zingiber officinale Rosc.) bioactive compounds have a capsaicin-like vanillyl portion, which has been attributed to thermogenic effect in previous experimental studies. However, studies conducted in humans have evaluated only the acute thermogenic effect of ginger, and demonstrated contradictory results. We evaluated the effect of long-term consumption of dry ginger extract on the resting energy expenditure (REE) of female adults with high body adiposity. METHODS: This is a secondary analysis of a randomized, double-blind, placebo-controlled clinical trial (NCT02570633). Participants age 18 to 60 y were randomly assigned into two groups: Intervention (600 mg of ginger extract daily) and placebo (cellulose). The intervention lasted 3 mo. Anthropometric measurements, blood pressure, and REE were assessed at each visit. RESULTS: A total of 66 female participants with high body adiposity were included in the analysis (mean age: 29 y [range, 20-55 y]; body mass index: 23.3 ± 2.7), with 30 participants in the ginger group and 36 in the placebo group. There were no significant differences in baseline characteristics between the groups. No differences were observed for group × time interaction on REE. Body composition and blood pressure followed the same pattern (all P > 0.05). CONCLUSIONS: Ginger extract consumption for 3 mo did not change the REE, anthropometric, and clinical data of female adults with excess adiposity.

Sex Differences Distinctly Impact High-Fat Diet-Induced Immune Dysfunction in Wistar Rats.

BACKGROUND: Immune function is altered during obesity. Moreover, males and females across different species demonstrate distinct susceptibility to several diseases. However, less is known regarding the interplay between high-fat diet (HFD) and sex in the context of immune function. OBJECTIVES: The objective was to determine sex differences on immune function in response to an HFD compared with a control low-fat diet (LFD) in Wistar rats. METHODS: At 5 wk of age, male and female Wistar rats were randomly assigned to 1 of 2 diets for 9 wk: ad libitum control LFD (20 kcal% fat, 53 kcal% carbohydrate, and 27 kcal% protein) or HFD (50 kcal% fat, 23 kcal% carbohydrate, and 27 kcal% protein). At 13 wk of age, rats were killed and splenocytes were isolated. Immune cell subsets were determined by flow cytometry. Immune cell function was determined by measuring the ex vivo cytokine production following stimulation with mitogens. Two-factor ANOVA was used to assess the main effect of sex, diet, and their interaction. RESULTS: Males gained more weight than females (410 ± 46 vs. 219 ± 45 g), independently of diet (P-sex < 0.01). The HFD led to a lower production of IL-2 while increasing the production of IL-10 (both P-diet ≤ 0.05), independently of sex. HFD-fed females had increased production of cytokines (IL-2 and IL-6) after stimulation with phorbol 12-myristate 13-acetate plus ionomycin (PMA+I), as well as a higher T-helper (Th) 1:Th2 balance compared with HFD-fed males (all P < 0.05). Males fed the HFD had significantly lower production of IL-2 upon stimulation compared with all other groups. CONCLUSIONS: Female Wistar rats developed a milder obesity phenotype and maintained enhanced cytokine production compared with males fed the HFD. Sex differences modulate immune function in the context of high-fat feeding and it should be considered in research design to establish personalized health-related recommendations.

Diabetes and mood disorders: shared mechanisms and therapeutic opportunities.

OBJECTIVE: The objective of this manuscript is to provide a comprehensive and critical overview of the current evidence on the association between Diabetes mellitus (DM) and mood disorders [i.e., Major depressive disorder (MDD) and bipolar disorder (BD)], and therapeutic opportunities. METHODS: We searched in MEDLINE (via Ovid) for placebo-controlled clinical trials published in the last 20 years that assessed drug repurposing approaches for the treatment of DM or mood disorders. RESULTS: We found seven studies that aimed to verify the effects of antidepressants in patients diagnosed with DM, and eight studies that tested the effect of antidiabetic drugs in patients diagnosed with MDD or BD. Most studies published in the last two decades did not report a positive effect of antidepressants on glycemic control in patients with DM. On the other hand, antidiabetic drugs seem to have a positive effect on the treatment of MDD and BD. CONCLUSIONS: While effect of antidepressants on glycemic control in patients with DM is still controversial, the use of antidiabetic drugs may be a promising strategy for patients with MDD or BD. Prospective studies are still needed.Key pointsMood disorders in patients with DM affect glycemic control, potentially increasing mortality risk.The effect of antidepressants on glycemic control in patients with DM is still controversial. The coexistence of complicated DM and a mood disorders would require a careful, individualised, and comprehensive evaluation.Insulin resistance may increase the risk of depressive symptoms and is associated with worse outcomes in BD.The use antidiabetic drugs may be a promising strategy for patients with MDD or BD. However, prospective trials are needed to prove a potential antidepressant activity of antidiabetic drugs.

The quality and inflammatory index of the diet of patients with migraine.

BACKGROUND: The association between diet and migraine has been reported in the literature, but only a few studies have evaluated whether the diet consumed by patients with migraine differs from individuals without migraine. OBJECTIVE: Herein, we aimed to investigate whether the quality and the Dietary Inflammatory Index (DII) of diet consumed by migraine patients differ from that consumed by healthy controls. We also evaluated whether the severity of migraine and headache frequency were associated with these parameters. METHODS: Patients of both sexes, aged between 18 and 65, with episodic migraine and healthy controls were enrolled in this cross-sectional study. Disability and impact caused by migraine and depressive symptoms were evaluated. Dietary intake was assessed using a 24-hour dietary recall and a three-day non-consecutive food record. The quality of the diet was calculated using the Healthy Eating Index (HEI)-2015 adapted to the Brazilian population, and DII was calculated based on the method developed by Shivappa et al. (2014). RESULTS: Ninety patients with migraine and 62 individuals without migraine were included in this study. The groups did not differ regarding age, sex, marital status, years of schooling, anthropometric characteristics, and depressive symptoms. Patients with migraine had lower HEI total score than controls, indicating that these patients have a lower quality of the diet. Patients with migraine also had higher DII than controls. Nevertheless, HEI and DII scores did not correlate with migraine frequency and severity. CONCLUSION: This study corroborates the view that the characteristics of the diet might be involved in migraine pathophysiology.

Nutrition-based interventions for mood disorders.

Introduction: 'Nutritional Psychiatry' is an emerging area of research that has great potential as an adjunctive tool for the prevention and treatment of diverse neuropsychiatric disorders. Several nutrition-related aspects, such as obesity, dietary patterns, gut microbiome composition and gut permeability, bioactive food compounds, and nutrients can influence pathways implicated in the pathophysiology of mood disorders.Areas covered: Here, the authors review the current evidence on nutrition-mood interaction and nutrition-based treatments for the two main mood disorders, i.e., major depressive disorder and bipolar disorder.Expert opinion: Consistent evidence from observational studies has pointed out the association between a 'healthy' diet, generally characterized by a higher intake of fruits, vegetables, legumes, nuts, whole grains, and good quality sources of protein (i.e. fish and/or seafood), and decreased risk of mood disorders and the parallel association between a 'Western' diet pattern and increased risk. However, only a few clinical trials have evaluated the effect of nutritional interventions on the treatment of these conditions. The bidirectional interaction between the brain and the gut, named 'brain-gut-microbiome axis' or 'gut-brain axis', plays a key role in the link between nutrition and mood disorders. Therefore, nutrition-based strategies for gut microbiota modulation are promising fields in mood disorders.

Accuracy of the MedGem® portable indirect calorimeter for measuring resting energy expenditure in adults with class II or III obesity.

BACKGROUND AND AIMS: The accuracy of some portable indirect calorimeters in estimating resting energy expenditure (REE) - and hence energy recommendations - among pre-bariatric patients is unknown. Our objective was to assess the accuracy of the MedGem® among individuals with class II or III obesity awaiting bariatric surgery. METHODS: Male and female adults who were awaiting bariatric surgery were recruited to this cross-sectional study. MedGem-derived oxygen consumption (O2) and REE were compared to O2 and REE from a metabolic cart. REE was also calculated using several common equations to assess the clinical utility of this portable tool. Body composition was assessed by dual energy X-Ray absorptiometry. Paired t-test and Bland-Altman analysis (expressed as bias [average difference] and limits of agreement [bias ± 2 standard deviations]) evaluated O2 and REE accuracy. RESULTS: Twenty-six individuals were included (34 ± 9 years old; n = 20, 76.9% female), with the majority (n = 15, 57.7%) having class II obesity. Neither O2 (MedGem: 283 ± 63 vs. metabolic cart: 293 ± 64 ml/min, p = 0.114) nor REE (MedGem: 1963 ± 437 vs. metabolic cart: 2047 ± 440 kcal/day, p = 0.057) were different between devices. Body composition did not relate to bias. The MedGem had wide limits of agreement for REE (-504 to 336 kcal/day), which was similar to predictive equations. CONCLUSIONS: Although REE from the MedGem was not different than REE from the metabolic cart, individual-level accuracy was poor and similar to predictive equations in patients with class II or III obesity. Nonetheless, efficacy of repeated assessments during weight loss warrant future investigation.

Altered Serum Levels of Renin-Angiotensin System Markers in Migraine.

OBJECTIVE: To compare the serum levels of renin-angiotensin system (RAS) components between patients with migraine and healthy controls, and to evaluate whether these levels are associated with migraine severity. We hypothesized that migraine would be associated with the activation of the inflammatory arm of the RAS, possibly leading to increased levels of angiotensin (Ang) II. BACKGROUND: Recent studies have proposed the use of drugs that interfere with RAS, a hormonal system primarily implicated in blood pressure regulation, as a prophylactic strategy for migraine. However, no previous studies have directly assessed RAS components in migraine. METHODS: This was a cross-sectional study involving 30 patients with episodic migraine who were in the interictal period and 20 healthy controls. This study was conducted at Hospital das Clínicas (Universidade Federal de Minas Gerais, Belo Horizonte, Brazil) outpatient clinic. Headache severity was evaluated using the Headache Impact Test, version 6 (HIT-6) and the Migraine Disability Test (MIDAS) questionnaires. Given that migraine is comorbid with mood disorders, depressive and anxious symptoms were evaluated using the Beck Anxiety and Depression Inventories (BDI and BAI), respectively. Clinical and demographic data were also collected. Serum levels of angiotensin-converting enzyme (ACE), ACE2, Ang II, and Ang (1-7) were measured by enzyme-linked immunosorbent assay. RESULTS: Patients with migraine and controls were comparable in age, body mass index, blood pressure, and depressive and anxious symptoms. Patients with migraine showed lower levels of ACE [85.2 (66.8, 101.2) vs 65.5 (54.2, 77.5); P = .005] and lower ACE/ACE2 ratio [4.3 (3.4, 5.2) vs 3.5 (2.9, 4.1); P = .032] than controls. Conversely, patients with migraine had higher levels of Ang II [309.7 ± 147.4 vs 605.4 ± 200.4; difference: -287.1 (95% CI: -391.4--182.8), P < .001] and Ang (1-7) [214.4 ± 155.8 vs 397.9 ± 217.9; difference: -184.6 (95% CI: -296.7--72.6), P = .001] than controls. There were no correlations between RAS serum markers and migraine severity scores (HIT and MIDAS) or depressive and anxious symptoms (BDI and BAI) (P > .05). CONCLUSIONS: Altogether, our results suggest the participation of RAS in migraine pathophysiology, but not in its severity.

Accuracy and reliability of a portable indirect calorimeter compared to whole-body indirect calorimetry for measuring resting energy expenditure.

BACKGROUND/OBJECTIVES: Resting energy expenditure (REE) is the largest component of total energy expenditure. As such, inaccurate estimation or measurement of REE may impact the development of individualized energy intake recommendations. The objective of this observational study was to assess the accuracy and reliability of REE measured with a portable indirect calorimeter with ventilated hood - Fitmate GS - compared to REE from whole-body indirect calorimetry (WBC). METHODS: REE was assessed using the Fitmate GS and compared to REE from WBC in male and female adults. Fitmate GS tests were repeated on a separate visit. Body fat percent, fat mass, and fat-free mass were assessed using dual X-ray absorptiometry in a subset of individuals with body mass index (BMI) ≥35 kg/m2. Paired t-tests and Bland-Altman analyses were used to describe REE accuracy; intra-class correlation coefficient (ICC) examined test-retest reliability of repeated Fitmate GS assessments. RESULTS: Fitmate GS and WBC REE was assessed in 77 adults (age 32 ± 8 years; 63.6% females; 53.2% with BMI ≥ 30 kg/m2). The Fitmate GS underestimated REE (1680 ± 420 vs. 1916 ± 461 kcal/day, p < 0.001) and wide limits of agreement were observed (95% confidence intervals [CI]: -727, 246 kcal/day). Bias was similar across sex and BMI categories and did not correlate to any body composition parameter. Fitmate GS ICC was 0.80 (95% CI: 0.70-0.87), indicating 'good' reliability with repeated testing after median follow-up of 4 days (interquartile range 2-7 days). CONCLUSION: The Fitmate GS did not accurately quantify REE but produced reliable REE measurements.