Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events

Launched by ARIEL UNIVERSITY · May 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how nutrition support can help reduce stomach-related side effects for people starting treatment with anti-obesity medications, specifically Wegovy© or Mounjaro©. The study will explore how nutritional guidance may improve symptoms, support better eating habits, and enhance overall quality of life as patients begin their weight loss journey. Initially, the trial will involve a small group of 10 patients, followed by a larger study with 120 participants at two medical centers in Israel.

To participate, individuals must be at least 18 years old, have a body mass index (BMI) of 27 or higher with related health issues like diabetes, or a BMI of 30 or more. Participants should be able to read and speak Hebrew. Those with certain health conditions or who have had specific surgeries may not qualify. If chosen for the study, participants will receive personalized nutrition advice from a registered dietitian before starting their medication, while those in the control group will follow standard care. Throughout the trial, participants will complete interviews and questionnaires to share their experiences and any changes they notice.

Gender

ALL

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