NCT06431308Completed
Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events
Adjuvant Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events During the Up-titration Phase
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 28 Mar 2024
- Start date
- 30 Jan 2025
- Primary completion date
- 5 Aug 2026
- Lead sponsor
- Ariel University
- Diseases
- Obesity
- NCT number
- NCT06431308
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From 30 Jan 2025 to the primary completion date, 5 Aug 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications or precautious for treatment with Wegovy© or Mounjaro© \[i.e., personal or family history of medullary thyroid cancer (MTC), personal history of multiple endocrine neoplasia type 2 (MEN2) syndrome, attempting conception, current pregnancy or breastfeeding\]
- previous bariatric surgery or endo-bariatric procedure
- treatment with AOM within a month before enrollment
- patients who underwent other major GI surgery prior to medication treatment
- chronic usage of promotility drugs or laxatives
- alcohol consumption exceeding 1 drink per day for women and 2 drinks per day for men .
- In addition, participants who decide not to initiate or stop Wegovy© or Mounjaro© treatment for more than two consecutive injections for any reason or who undergo bariatric surgery or endoscopic sleeve gastroplasty during the study period will be excluded from the study
Other illness
- patients with type 1 diabetes mellitus
- patient with underlying GI disease \[e.g., gastroparesis, celiac, Inflammatory Bowel Disease (IBD)\]
- patients with uncontrolled mental illness
Other
- presence of chronic pancreatitis
- a positive diagnosis of small-intestinal bacterial overgrowth (SIBO)
- patients with active gastritis, gastroenteritis
- significant cognitive deterioration
Who the study is looking for
- individuals aged ≥ 18 years
- eligible to receive AOM \[i.e., BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with at least one adiposity-related coexisting condition (e.g., diabetes or pre-diabetes, hypertension, dyslipidemia, obstructive sleep apnea, fatty liver, cardiovascular disease)\]
- who can read and speak Hebrew.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ariel University Coordinator of this site? Confirm its status | Ariel | Israel | Unknown status |
| Rabin Medical Center- Beilinson Hospital Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Assuta Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.