Effects of structured Ramadan Nutrition Plan on glycemic control and variability using continuous glucose monitoring in individuals with type 2 diabetes: A pilot study.

BACKGROUND AND AIMS: Continuous glucose monitoring (CGM) has been increasingly used in recent years to evaluate glycemic control and variability in individuals with diabetes observing Ramadan fasting. However, the effectiveness of the Ramadan Nutrition Plan (RNP) in individuals with type 2 diabetes (T2D) using CGM-derived measures has not been investigated. The study aimed to evaluate the effects of structured RNP versus standard care using CGM in individuals with T2D. METHODS: This parallel non-randomized interventional study with patients' preference design involved 21 individuals with T2D (mean age: 49 ± 10 years, BMI: 30.0 ± 6.2 kg/m2). Participants chose to receive either structured RNP (sRNT; structured Ramadan Nutrition Therapy group; n = 14) or standard care (SC; n = 7). Participants wore CGM 5 days before Ramadan and during Ramadan. CGM-derived measures of glycemic variability were calculated using Glyculator version 2.0. RESULTS: Compared to the SC group, the sRNT group significantly reduced their fasting blood glucose levels, HbA1c, total cholesterol, diastolic blood pressure, and increased dietary fiber intake. CGM data showed the sRNT group had significantly lower average sensor glucose, peak sensor value, estimated A1c, percentage and duration of time-above-range, J-index, mean amplitude of glycemic excursion (MAGE), and continuous overall net glycemic action (CONGA); and a significantly higher percentage of time-in-range (TIR). CONCLUSIONS: The structured RNP significantly improved clinical outcomes, glycemic control and variability in individuals with T2D. The study highlights the importance of utilizing CGM sensor data to monitor glycemic excursions during Ramadan fasting. Adequately powered randomized controlled trials are needed to confirm the findings.

The Underestimated and Overlooked Burden of Diarrhea and Constipation in Cancer Patients.

PURPOSE OF REVIEW: This review aims to summarize and discuss the diverse causes of two major gastrointestinal dysfunction symptoms, diarrhea and constipation, in cancer patients. We also discuss short- and long-term clinical, economic, and humanistic consequences, including the impact on cancer treatment regimens and patient quality of life, highlighting the limitations of the literature. RECENT FINDINGS: Diarrhea and constipation as a result of cancer and its treatment can risk the success of anti-cancer therapies by requiring treatment delay or withdrawal, and imposes a substantial humanistic burden in patients with cancer. Despite its importance and frequency, gastrointestinal side effects may be overlooked due to the focus on cancer treatment, and the impact on patients may be underestimated. Additionally, the burden reported may not fully reflect current cancer management, particularly the true impact of economic consequences. A full understanding of the burden of diarrhea and constipation in patients with cancer is required, including broad evaluation of clinical considerations, the patient experience, and an updated assessment of economic burden. This would improve caregivers' appreciation of the impact of gastrointestinal dysfunction and aid the prioritization of future research efforts.

Changes in dietary intake improve glycemic control following a structured nutrition therapy during Ramadan in individuals with type 2 diabetes.

BACKGROUND AND AIMS: It is unknown whether dietary modifications during Ramadan could influence glycemic control in diabetes. This study assessed dietary intake following structured Ramadan nutrition therapy and determined the association between changes in dietary intake and glycemic control parameters in patients with type 2 diabetes. METHODS: This was an 8-week, parallel-group, non-randomised study of 60 type 2 diabetes patients who opted for structured Ramadan Nutrition Therapy (sRNT; n = 38) or standard care (SC; n = 22) group. The sRNT group received a structured Ramadan Nutrition Plan incorporated with diabetes-specific formula throughout the study, while SC received standard nutrition care. The 3-day food records assessed dietary intake at three-time points. RESULTS: At baseline, dietary characteristics were comparable; both groups had macronutrient intakes within the recommended range, but inadequate intakes of fiber and 11 essential micronutrients. After 8 weeks, the sRNT group significantly reduced intakes of carbohydrate, dietary glycemic index, glycemic load, and increased percentage of total energy intake from protein, fiber, pyridoxine, vitamin C, vitamin D, calcium, and chromium compared with the SC group. In the sRNT group, compliance to diabetes-specific formula predicted changes in HbA1c (p = 0.024), while fiber intake predicted fasting plasma glucose (p = 0.035), after adjusting for age, sex, weight changes and other dietary variables. CONCLUSION: Intakes of certain nutrients improved significantly in sRNT group after 8 weeks of receiving a structured Ramadan Nutrition Plan compared to the standard care. The structured Ramadan Nutrition Plan with the incorporation of diabetes-specific formula significantly improved glycemic control and dietary adequacy during Ramadan fasting.

A Meal Replacement Program for the Treatment of Obesity: A Cost-Effectiveness Analysis from the Swiss Payer's Perspective.

BACKGROUND: Obesity is a disease associated with high direct medical costs and high indirect costs resulting from productivity loss. The high prevalence of obesity generates the need for payers to identify cost-effective weight loss approaches. Among various weight management techniques, the OPTI (Optifast®) program is a clinically recognised total meal replacement diet that can lead to significant weight loss and reduction in complications. This study's objective is to assess OPTI program's cost-effectiveness in Switzerland in comparison to "no intervention" and pharmacotherapy. METHODS: An event-driven decision-analytic model was used to estimate the payer's cost savings through the reimbursement of OPTI program over a 1-year period as well as a lifetime in Switzerland. The analysis was performed on a broad population of people with obesity with a body mass index (BMI) higher than 30 kg/m2 following the OPTI program vs two comparators (liraglutide and "no intervention"). The model incorporated a higher risk of complications due to an increased BMI and their related healthcare costs. Data sources included published literature, clinical trials, official Swiss price/tariff lists and national population statistics. The primary perspective was that of a Swiss payer. Scenario analyses - for example, for patients with existing complications (such as myocardial infarction, stroke, type 2 diabetes mellitus) or severe obesity - were conducted to test the robustness of the results. RESULTS: The OPTI program results in cost savings of CHF 20,886 (€ 18,724) and CHF 15,382 (€ 13,790) per person compared with "no intervention" and liraglutide 3 mg, respectively. In addition, OPTI program led to 1.133 and 0.734 quality-adjusted life years (QALYs) gained respectively against its comparators. Scenario analyses showed similar outcomes with cost savings and QALYs gained. CONCLUSION: OPTI program is a dominant strategy compared to "no intervention" and liraglutide 3 mg as it leads to both cost savings and QALY gain. Therefore, reimbursing the OPTI program for patients with obesity would be cost-effective for Swiss payers.

Health-Related Quality of Life in Weight Loss Interventions: Results from the OPTIWIN Trial.

Obesity is highly prevalent and associated with several adverse outcomes including health-related quality-of-life (HRQoL), work productivity, and activity impairment. The objective of this study is to examine group differences in HRQoL and labor-related health outcomes among participants in the OPTIWIN program, which compared the effectiveness of two intensive behavioral weight loss interventions. Participants (n = 273) were randomized to OPTIFAST®(OP) or food-based (FB) dietary interventions for 52 weeks. HRQoL and labor-related health outcomes were measured at baseline, week 26, and week 52, using two questionnaires. At baseline, there were no differences between groups on the Impact of Weight on Quality-of-Life Questionnaire (IWQOL-Lite). At week 26, the OP group had statistically significant differences towards better HRQoL for Physical Function, Self-Esteem, and the total score compared with the FB group. At week 52, the OP group showed better HRQoL in the total score (p = 0.0012) and in all but one domain. Moreover, the adjusted change-from-baseline normalized total score at week 52 was -5.9 points (p = 0.0001). Finally, the mean IWQOL-Lite normalized score showed that HRQoL improves by 0.4442 units (p < 0.0001) per kg lost, and that greater weight reduction was positively associated with better HRQoL. No statistically significant group differences were found with the Work Productivity and Activity Impairment (General Health) (WPAI-GH) Questionnaire. HRQoL improves with highly intensive, well-structured weight loss interventions. Greater weight loss lead to larger improvements. The lack of negative effect on productivity and activity suggests that these interventions may be compatible with an active work lifestyle.

Ramadan-focused nutrition therapy for people with diabetes: A narrative review.

AIMS: This narrative review aimed to synthesize the evidence on the effects of Ramadan-focused nutrition therapy for people with diabetes. METHODS: We searched MEDLINE (via PubMed) and Science Direct databases for articles that included the component of nutrition for adult patients with type 2 diabetes (T2D), published in English between 2010 and 2020. RESULTS: Fourteen studies met the criteria. Eight of 14 studies had an intervention with a control arm. In comparison to the control group, all studies (n = 8) showed a reduction in hypoglycemic events. However, only half of these studies (n = 4) had shown at least one positive clinical outcome. Features of nutrition therapy that appeared to have favorable clinical outcomes include individualized caloric prescription; distributing carbohydrates equally between Suhoor, Iftar and snacks; providing meal plans; adjusting food intake to suit Ramadan; and incorporating diabetes-specific formula as part of Suhoor or snack. CONCLUSIONS: The review provides evidence for the effectiveness of Ramadan-focused nutrition therapy among people with T2D and identifies key features of nutrition therapy that may provide favourable clinical outcomes. Additional data on dietary quality and adequacy during Ramadan fasting warrants further studies.

Comparison of Structured Nutrition Therapy for Ramadan with Standard Care in Type 2 Diabetes Patients.

(1) Background: Structured nutrition therapy (NT) is essential for the management of type 2 diabetes (T2D), but the optimal delivery during Ramadan fasting remains unclear. The present study aimed to evaluate the effect of structured NT program versus standard care in patients with T2D during Ramadan. (2) Methods: The present study was an 8-week, parallel, non-randomized study with patients' preference design involving 64 patients with T2D. The participants were asked to choose their preferred group, i.e., structured NT (Structured Ramadan NT, sRNT) or standard care (SC). The participants in the sRNT group received a Ramadan-focused nutrition plan, including a diabetes-specific formula throughout the study, whereas the patients in the SC group received standard nutrition care. Study outcomes included clinical outcomes and quality of life (QoL). Data was analyzed using two-way repeated-measures ANOVA and linear mixed-effects model. (3) Results: More than half of the participants (n = 38, 63%) chose sRNT as their preferred group. Both groups had comparable baseline characteristics. After 8-weeks of the respective intervention, participants in the sRNT group had lower levels of fasting plasma glucose (-0.9 ± 0.3 mmol/L vs. 0.2 ± 0.3 mmol/L, p < 0.05), triglycerides (-0.21 ± 0.08 mmol/L vs. 0.20 ± 0.17 mmol/L, p < 0.05), and self-monitoring glucose at pre-dawn (6.9 mmol/L vs. 7.8 mmol/L, p < 0.05) and pre-bedtime (7.6 mmol/L vs. 8.6 mmol/L, p < 0.05) than participants in the SC group. Although not different between groups, HbA1c levels decreased significantly in the sRNT (-0.72 ± 0.16%, p < 0.001) but not in the SC group (-0.35 ± 0.24%, p = 0.155). QoL and satisfaction scores improved significantly in sRNT group, but not in SC group. (4) Conclusions: The structured NT regimen for Ramadan is a feasible and beneficial program for T2D patients observing Ramadan fasting as it showed an improvement in clinical outcomes and QoL.

A health economic model to assess the cost-effectiveness of OPTIFAST for the treatment of obesity in the United States.

OBJECTIVES: Obesity is associated with high direct medical costs and indirect costs resulting from productivity loss. The high prevalence of obesity generates a justified need to identify cost-effective weight loss approaches from a payer's perspective. Within the variety of weight management techniques, OPTIFAST is a clinically recognized and scientifically proven total meal replacement Low Calorie Diet that provides meaningful results in terms of weight loss and reduction in comorbidities. The objective of this study is assess potential cost-savings of the OPTIFAST program in the US, as compared to "no intervention" and pharmacotherapy. METHODS: An event-driven decision analytic model was used to estimate payer's cost-savings from reimbursement of the 1-year OPTIFAST program over 3 years in the US. The analysis was performed for the broad population of obese persons (BMI >30 kg/m2) undergoing the OPTIFAST program vs liraglutide 3 mg, naltrexone/bupropion and vs "no intervention". The model included the risk of complications related to increased BMI. Data sources included published literature, clinical trials, official US price/tariff lists, and national population statistics. The primary perspective was that of a US payer; costs were provided in 2016 US dollars. RESULTS: OPTIFAST leads over a period of 3 years to cost-savings of USD 9,285 per class I and II obese patient (BMI 30-39.9 kg/m2) as compared to liraglutide and USD 685 as compared to naltrexone/bupropion. In the same time perspective, the OPTIFAST program leads to a reduction of cost of obesity complications of USD 1,951 as compared to "no intervention", with the incremental cost-effectiveness ratio of USD 6,475 per QALY. Scenario analyses also show substantial cost-savings in patients with class III obesity (BMI ≥ 40.0 kg/m2) and patients with obesity (BMI = 30-39.9 kg/m2) and type 2 diabetes vs all three previous comparators and bariatric surgery. CONCLUSIONS: Reimbursing OPTIFAST leads to meaningful cost-savings for US payers as compared with "no intervention" and liraglutide and naltrexone/bupropion in obese patients. Similar results can be expected in matching healthcare settings of other countries. Moreover, OPTIFAST has additional clinical and economic advantages through very low complication and adverse events rates.

Mini Nutritional Assessment in patients with Parkinson's disease: correlation between worsening of the malnutrition and increasing number of disease-years.

OBJECTIVE: To monitor the nutritional status of patients with Parkinson's disease using the Mini Nutritional Assessment (MNA) questionnaire. PATIENTS AND METHODS: This was a 3-year longitudinal study conducted in a national referral centre for Parkinson's disease and other movement disorders. The cohort included 61 Parkinson's disease patients, 37 men and 24 women, mean age of 70.5 +/- 5.5 years, mean duration of disease 9 +/- 6.3 years; 35 patients were followed-up after 3 years. RESULTS: MNA score diminished from 24.9 +/- 1.6 to 24 +/- 2.5 (P = 0.02); the proportion of patients at risk of malnutrition increased from 22.9% to 34.3%. A linear correlation was observed between MNA score and the duration of disease (P = 0.0096). The dietary assessment subscore significantly diminished (8.6 versus 8.1; P = 0.0009) as did body mass index (25.9 +/- 3.5 kg/m(2) versus 27.1 +/- 3.1 kg/m(2); P = 0.001). CONCLUSIONS: The evaluation of nutritional status should be part of the routine work-up of a Parkinson's disease patient. Dietary education should be included amongst the therapeutic measures designed to improve the general conditions in Parkinson's disease.

Diet with LPP for renal patients increases daily energy expenditure and improves motor function in parkinsonian patients with motor fluctuations.

OBJECTIVE: To establish whether a diet based on the usage of low-protein products for renal patients (LPP) is associated with higher energy expenditure (EE) than a free low-protein diet (NO-LPP) by calculating 24 h EE by indirect calorimetry using an electronic armband monitor. DESIGN: Randomized, cross-over, single-blind, pilot clinical trial performed comparing two different low-protein dietary regimens. SUBJECTS: Forty-two days with LPP and 42 days with NO-LPP regimen in six patients with Parkinson's disease with levodopa. METHODS: Monitoring patient response to two different nutritional schemes through indirect calorimetry (armband), BMI, Patient Global Improvement Scale. RESULTS: Mean total EE was 1731 +/- 265 kcal/day with NO-LPP vs. 1903 +/- 265 kcal/day with LPP (p = 0.02). CONCLUSIONS: The usage of LPP increases EE and improves motor function in PD patients to a greater extent than NO-LPP dietary regimen. Calorie intake should be increased to prevent malnutrition in the long-term.

Special low-protein foods ameliorate postprandial off in patients with advanced Parkinson's disease.

Protein intake interferes with levodopa therapy. Patients with advanced Parkinson's disease (PD) should restrict daily protein intake and shift protein intake to the evening. For further reduction of protein intake in the first part of the day, special low-protein products (LPP) should be used instead of normal food products at breakfast and lunch. We studied the efficacy of LPP on postprandial off periods, in PD patients on levodopa therapy. The methods included a randomized, cross-over, single-blind, pilot clinical trial comparing a 2-month balanced diet with a 2-month LPP diet in 18 PD patients with motor fluctuations. The off phases were significantly shorter after LPP diet than after balanced diet (postprandial off, 49 +/- 73 min vs. 79 +/- 72 min and total off, 164 +/- 148 min vs. 271 +/- 174 min, both P < 0.0001). Moreover, a reduction in total off time during LPP diet (3.3 +/- 2.7 hr vs. 4.7 +/- 3.3 hr, P < 0.0001), occurred also in the 9 patients who did not experience subjective benefit. No significant changes in hematological and biochemical variables or body composition were recorded; a slight reduction in body weight (mean, -1.8%) was observed. Consumption of LPP in the first part of the day ameliorates off periods in PD patients, but additional studies including pharmacokinetics are needed.

Protein intake in Parkinsonian patients using the EPIC food frequency questionnaire.

The dietary habits of 45 Italian patients with Parkinson's disease (PD) and their spouses were investigated using the EPIC food frequency questionnaire. Average daily energy intake was similar, but PD patients consumed significantly more vegetable proteins and carbohydrates (both +18%; P = 0.01 and P = 0.001, respectively). Daily protein intake, which interferes with levodopa absorption, was 50% higher than the recommended daily allowance (1.2 vs. 0.8 g/kg) in both PD patients and spouses and was significantly higher in patients with moderate/severe symptoms (1.27 +/- 0.29 vs. 1.07 +/- 0.28 g/kg; P < 0.001). In patients taking levodopa, there was a correlation between daily levodopa dosage and protein intake (P = 0.027). Dietary habits of patients with advanced and/or fluctuating PD should always be checked, with particular reference to protein intake.

Body weight gain rate in patients with Parkinson's disease and deep brain stimulation.

We evaluated body weight changes in patients with Parkinson's disease (PD) after electrode implantation for deep brain stimulation (DBS) in the subthalamic nucleus (STN) in relation to clinical improvement. Thirty PD patients who received STN DBS were included (22 men, 8 women; mean age, 60.0 +/- 7.1 years; mean PD duration, 13.5 +/- 3.7 years; mean body mass index [BMI], 21.6 +/- 3.0 kg/m2). Body weight, physical activity, and Unified Parkinson's Disease Rating Scale (UPDRS) scores were noted before and 3 and 12 months after the procedure. Significant weight gain occurred in 29 patients; the mean increase was 14.8 +/- 9.8% of initial body weight in 1 year. Of the patients, 46.5% reported weight gain in the first 3 months, 21.4% gradual weight gain in the first 6 months, and 32.1% a slow increase for 1 year. Mean BMI increased up to 24.7 +/- 3.7 kg/m2. After 1 year, mean UPDRS motor score improved significantly in off and in on; and therapy complications improved by 91.0 +/- 17.0%. BMI changes at 3 and 12 months were significantly correlated to dyskinesia score changes, and levodopa dosage was not. In PD, STN DBS produces not only symptom control, but also weight gain. DBS candidates should be given nutritional counseling before the intervention to prevent rapid and/or excessive weight gain.