Nutritional therapy for managing gastrointestinal issues in obesity medication

Adjuvant Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events During the Up-titration Phase

This study is testing if a special nutrition plan can help people starting new obesity medications feel better and improve their overall health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ariel University (other)
• Locations: 3 sites (Ariel and 2 other locations)
• Trial ID: NCT06431308 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of a nutritional intervention on gastrointestinal symptoms and other health parameters in patients starting incretin-based anti-obesity medications. Initially, a pilot study will be conducted with 10 patients at the Tel-Aviv Assuta Medical Center, followed by a larger multi-center randomized controlled trial involving 120 patients at both the Assuta Medical Center and Rabin Medical Center. The nutritional protocol will be developed based on literature reviews and consultations with healthcare professionals and patients. The study aims to improve treatment adherence and quality of life during the medication initiation phase.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a BMI of 30 or higher, or 27 or higher with related health conditions, who can read and speak Hebrew.

Not a fit: Patients with contraindications to the medications, previous bariatric surgery, or certain gastrointestinal diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance patient tolerance to obesity medications and improve overall treatment outcomes.

How similar studies have performed: While this specific approach is novel, similar studies have shown promise in improving patient outcomes with nutritional interventions in obesity treatment.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* presence of chronic pancreatitis
* treatment with AOM within a month before enrollment
* patients with type 1 diabetes mellitus
* patients who underwent other major GI surgery prior to medication treatment
* patient with underlying GI disease \[e.g., gastroparesis, celiac, Inflammatory Bowel Disease (IBD)\]
* a positive diagnosis of small-intestinal bacterial overgrowth (SIBO)
* patients with active gastritis, gastroenteritis
* chronic usage of promotility drugs or laxatives
* patients with uncontrolled mental illness
* significant cognitive deterioration
* 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

Where this trial is running

Ariel and 2 other locations

• Ariel University — Ariel, Israel (RECRUITING)
• Rabin Medical Center, Beilinson Hospital — Petah Tikva, Israel (NOT_YET_RECRUITING)
• Assuta Medical Center — Tel Aviv, Israel (RECRUITING)

Study contacts

• Study coordinator: Shiri Sherf-dagan, Ph.D

Conditions: Obesity, Drug