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

Ariel University

Status: Enrolling

Conditions: Obesity; Drug

Treatments: Behavioral: nutritional intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06431308

ASMC-0003-24

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Nutritional intervention group

Experimental group

Description:

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

Treatment:

Behavioral: nutritional intervention

Control group

No Intervention group

Description:

* 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.