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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Israel
Ariel University
RECRUITING
Ariel
Rabin Medical Center, Beilinson Hospital
NOT_YET_RECRUITING
Petah Tikva
Assuta Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
Shiri Sherf-dagan, Ph.D
shiris@ariel.ac.il
+972747288004
Backup
Rotem Refaeli
rotem2310@gmail.com
+972545797995
Time Frame
Start Date: 2025-01-30
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 120
Treatments
Experimental: Nutritional intervention group
Nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s).
No_intervention: Control group
* Usual nutrition care treatment for patients treated with Wegovy© or Mounjaro© (RCT).~* Prior to the initiation of AOM treatment, participant will receive general nutrition guidance based on national recommendations according to the Mediterranean diet.
Related Therapeutic Areas
Sponsors
Leads: Ariel University

This content was sourced from clinicaltrials.gov