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

NCT06431308 | Recruiting

• 1 other identifier: ASMC-0003-24
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Obesity; Drug

Outcome Measures

Primary Outcomes (4)

• Gastrointestinal symptoms assessment

  GI symptoms rating scale (GSRS) - assess the degree of specific GI complaints Every question is rated by seven graded Likert-type scale (1 represents the absence of troublesome symptoms and 7 represents very troublesome symptoms) while a higher score of the whole questionnaire and by dimension represents more severe symptoms.

  Baseline and at the end of the study period (20 weeks)

• Defecation texture

  Bristol stool scale - classifying the form of human feces into seven categories. Type 1-2 are considered abnormal hard stools and indicative of constipation type, and type 5-7 are considered abnormally loose/liquid stools and indicative of diarrhea or urgency

  Baseline and at the end of the study period (20 weeks)

• Bowel Movement (BM) frequency

  will be assessed according to five acceptable categories: \>3 BMs/day, 2-3 BMs/day, 1-2 BMs/day, 3-4 BMs/week, \<3 BMs/week

  Baseline and at the end of the study period (20 weeks)

• Participants gastrointestinal symptoms report

  Participant subjective and objective reporting of GI symptoms

  Baseline, at the end of the study period (20 weeks) and weekly until 20 weeks (for subjective GI symptoms report only)

Secondary Outcomes (15)

• Incretin-based AOM treatment discontinuation rate

  At the end of the study period (20 weeks) and weekly until 20 weeks

• Anthropometric measures - weight

  Change from baseline at the end of the study period (20 weeks)

• Anthropometric measures - waist circumference (WC)

  Change from baseline at the end of the study period (20 weeks)

• Body composition - fat mass (kg)

  Change from baseline at the end of the study period (20 weeks)

• Dietary intake

  Change from baseline at the end of the study period (20 weeks)

Other Outcomes (13)

• Biochemical tests

  At baseline

• Demographics - age

  At baseline

• Demographics - marital status

  At baseline

Study Arms (2)

Nutritional intervention group

EXPERIMENTAL

Nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s).

Behavioral: nutritional intervention

Control group

NO INTERVENTION

* 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.

Interventions

nutritional intervention BEHAVIORAL

A nutrition guidance before initiation of AOM treatment include recommendations for food choices and eating habits to minimize the occurrence and severity of GI symptoms during the up-titration phase, will be given by registered dietitian (RD) from the study team. Next, each week, participants will provide weekly reports of GI symptoms occurrence and severity, by responding to queries sent via WhatsApp/SMS and for occurring symptoms, an automatically structured nutrition and behavioral treatment recommendations will be sent . If participants expressed an interest in personalized dietary guidance on this matter, the study team RD will contact him/her by telephone, within a range of 48 hours, to provide individualized recommendations. Three days after each report of GI symptom(s), participants will receive an additional message and will be asked to report the occurrence and severity of the GI symptom, and their compliance with the specific dietary instructions received.

Nutritional intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ariel University: lead

Study Sites (3)

Ariel University

Ariel, 40700, Israel

RECRUITING

Rabin Medical Center, Beilinson Hospital

Petah Tikva, 4941492, Israel

NOT YET RECRUITING

Assuta Medical Center

Tel Aviv, 6971028, Israel

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shiri Sherf-dagan, Ph.D

CONTACT

+972747288004; shiris@ariel.ac.il

Rotem Refaeli

CONTACT

+972545797995; rotem2310@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: May 28, 2024
• Study Start: January 30, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 30, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

IL (3)