Clinical trials

Background: Childhood obesity is a multifactorial health condition associated with profound metabolic, psychosocial, and socioeconomic ramifications across the lifespan. Among eating behaviors associated with obesity, limited attention has been given to chewing and food texture as pathways that may influence energy intake and weight regulation. Existing pediatric research remains scarce, methodologically heterogeneous, and often inconclusive. Aims: This study aims to examine associations between oral processing behaviors during a standardized meal, including eating duration, eating rate, Ghrelin levels, and anthropometric measures in healthy children. Methods: Participants responding to public advertisements will be screened for eligibility, including age (6-11 years), health status, absence of food allergies or intolerances, dental or developmental problems, and measured weight and height to achieve a sample of 40 children with obesity and 40 with normal weight. In a randomized crossover design, participants will consume two isocaloric, non-processed test meals differing in food texture (soft vs. hard) during separate laboratory visits. Eating behavior will be objectively assessed using a Universal Eating Monitor with synchronized video analysis to quantify chewing time, number of chews, and eating rate. Salivary ghrelin, subjective satiety (measured using visual analog scales), and total daily energy intake (assessed via 24-hour dietary recall) will be evaluated, along with anthropometric, body composition, strength measures, and sociodemographic and behavioral data. To account for familial and shared environmental influences on eating behavior, at least one parent will undergo a parallel assessment, conducted separately from the participating child. Participants will receive a modest shopping voucher to facilitate retention. Associations between oral processing behaviors, physiological responses, and weight status will be examined using multivariable regression models. Exploratory mediation analyses will be conducted to assess whether ghrelin and satiety responses partially account for the observed associations.

The UPGRADE Study will examine how food-processing level and nutritional quality affect energy intake, eating rate, satiety, and glycemic response. In a randomized-order crossover design, each participant will consume three laboratory test meals: low processing/high nutritional quality, high processing/high nutritional quality, and high processing/low nutritional quality. Food intake and eating rate will be measured using a Universal Eating Monitor, alongside satiety, glycemic response, and energy intake during the remainder of the day. The study will also explore whether anxiety and nutrition insecurity influence these responses. Comparisons between participants in Israel and the United States will assess whether background Mediterranean versus Western dietary patterns modify meal responses. The high-processing, low-nutritional-quality meal is expected to result in greater energy intake and eating rate, lower satiety, and a more pronounced glycemic response. Findings will inform future trials and dietary recommendations concerning ultra-processed foods and nutritional quality.

Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden. Recent evidence highlights the role of low-grade inflammation, impaired intestinal permeability and gut microbiota dysbiosis in the pathophysiology of non-constipated IBS (IBS with predominate diarrhea; IBS-D and mixed type IBS; IBS-M). Most patients report food-related symptom exacerbation, making dietary intervention a cornerstone of treatment. While the low-FODMAP diet (LFD) is widely used to reduce fermentable carbohydrates and alleviate symptoms, it may negatively affect microbial diversity and lacks anti-inflammatory effects. In contrast, the Crohn's Disease Exclusion Diet (CDED), developed for Crohn's disease, has demonstrated the ability to reduce intestinal inflammation, improve barrier function, and promote a favorable microbiota profile. These mechanisms may be relevant and beneficial in IBS, but have yet to be studied in this population. Objectives: To compare the efficacy of a modified CDED to the LFD for the treatment of non-constipated IBS symptoms, Hypothesis: A modified CDED will be at least as effective as the LFD in alleviating non-constipation IBS symptoms, stool consistency, quality of life, and psychological distress, while demonstrating superior effects on markers of low-grade inflammation, gut microbiota composition, and intestinal permeability. Methods: This is a single-center, open-label, randomized study to be conducted at the Gastroenterology Department of Sheba Medical Center. 136 adults diagnosed with Rome IV-defined IBS-D or IBS-M and an IBS Symptom Severity Score (IBS-SSS) ≥175 will be randomized 1:1 to receive either a modified CDED or the LFD for 6 weeks. Accounting for a 10% dropout rate, the total sample size will be 150. Following a 14-day screening period, eligible participants will undergo data collection at baseline, week 3 and week 6. Visit 1 (screening) will be conducted on-site; visits 2-4 will be remote. Participants will complete daily symptom diaries \[Bristol Stool Form Scale (BSFS) and GI Visual Analogue Scale (VAS)\], and weekly IBS-SSS. Validated questionnaires assessing psychological distress, somatization, extraintestinal symptoms, and quality of life will be administered at each time point. Stool samples will be collected at baseline, week 3, and week 6. Fecal calprotectin (FC) and α1-Antitrypsin (A1AT) will be analyzed as markers of intestinal inflammation and permeability. Microbiota analysis will be conducted using 16S rRNA gene sequencing, with evaluation of microbial diversity, taxonomic shifts, and associations with clinical and biological outcomes. Significance: This is the first study to evaluate the modified CDED as a dietary intervention for the treatment of IBS. It may offer a novel, inflammation-targeted alternative treatment for IBS.

The goal of the study is to evaluate the effect of nutrition intervention on gastrointestinal symptoms, treatment discontinuation rate, nutritional parameters (e.g., dietary intake and eating habits), anthropometric measures, functional parameters, and QOL during the initiation and up-titration phase of incretin-based Anti Obesity Medications (AOM) treatment in patients with overweight/obesity. The nutrition intervention protocol will be developed based on literature review, focus groups with health care professionals, and patient interviews. A single-center pilot study will be performed at the Tel-Aviv Assuta Medical Center, among 10 patients who are about to initiate long-term weight management treatment with Wegovy© (semaglutide 2.4 mg), followed by a multi-center, parallel design open-label, RCT, which will be conducted at the Tel-Aviv Assuta Medical Center and Rabin Medical Center - Beilinson Hospital, in 120 patients who are about to initiate long-term weight management treatment with Wegovy© or Mounjaro© . The intervention group will receive nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). The control group will receive the usual nutrition care for patients treated with AOM. Primary outcomes (gastrointestinal symptom assessment) and secondary outcomes (incretin-based AOM discontinuation rate, nutritional parameters, anthropometrics, functional parameters and QOL) will be evaluated by interviews, questionnaires and measurements at baseline, at the end of Wegovy© or Mounjaro© titration phase \[20 weeks (T1)\] and weekly during the study period (for GI symptoms assessment).

Background: The Bedouin community in the Negev faces high rates of type 2 diabetes, low treatment adherence, and increased disease complications. Transition to urban living and changing dietary patterns have exacerbated these issues. Current interventions often overlook the potential of culturally tailored approaches leveraging kinship ties and community resources. This study seeks to address these gaps by examining the impact of a family-centered intervention program. Objectives: Primary: Assess the effect of community intervention on Mediterranean diet adherence. Secondary: Evaluate changes in fasting glucose, HbA1c, lipid profiles, BMI, physical activity, and quality of life. Methodology: Study Design: Controlled community intervention trial with two groups (intervention and control). Participants: 170 Bedouin adults diagnosed with overweight, obesity, metabolic syndrome, prediabetes, or type 2 diabetes. Intervention: 10 sessions over 12 months focusing on nutrition, physical activity, and behavioral changes, tailored to cultural norms. Control: Routine care without added intervention. Outcome Measures: Lab tests (HbA1c, lipid profiles), anthropometric measures, Mediterranean diet adherence, physical activity, quality of life, and social belonging. Recruitment and Data Collection: Participants will be recruited via Clalit clinics in Rahat, with the support of local community leaders. Data will be collected through medical records, questionnaires, and physical assessments at baseline, 6, and 12 months. Data Analysis: Statistical analysis will be performed using SAS/SPSS, employing ANOVA, Chi-square tests, and regression models for outcome prediction. Ethical Considerations: Participants' privacy will be ensured through coded data storage. The study will comply with Helsinki guidelines, and participants can withdraw at any time. Conclusion: This study aims to provide culturally tailored interventions to improve health outcomes in the Bedouin community, potentially serving as a model for similar minority groups globally.