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NCT Number: NCT06431308

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ariel University, Ariel, Israel

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Gastrointestinal symptoms assessment

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

    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.

  2. Defecation texture

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

    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

  3. Bowel Movement (BM) frequency

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

    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

  4. Participants gastrointestinal symptoms report

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

    Participant subjective and objective reporting of GI symptoms

Secondary outcomes

  1. Incretin-based AOM treatment discontinuation rate

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

  2. Anthropometric measures - weight

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

    Weight (kg) by digital scale

  3. Anthropometric measures - waist circumference (WC)

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

    will be measured by tape measure (cm)

  4. Body composition - fat mass (kg)

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

    Body composition analysis using Inbody370S®

  5. Dietary intake

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

    24-hour dietary recall (24HR)

  6. Eating habits assessment

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

    General questions regarding eating patterns, hydration and foods intolerance

  7. Eating habits assessment - Control of Eating

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

    Control of Eating Questionnaire (CoEQ) - The of CoEQ consists of 21 items (19 questions are rated by 100 mm VAS, and two question are open-ended). Greater score represents greater levels of Craving Control.

  8. Functional parameters - muscle strength

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

    Handgrip (HG) muscle Strength - measure static muscle strength (kg) of the upper extremities by a digital hand dynamometer (Jamar plus digital©)

  9. Functional parameters- leg strength and endurance

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

    30-seconds sit and stand test - counts the number of times the patient stands in 30 seconds. Higher scores means a better outcome.

  10. Quality of life assessment

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

    EQ-5D-3L questionnaire -include the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) .The EQ-5D-3L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.The EQ VAS records the patient's self-rated health. Participants will be asked to subjectively rate their overall state of health by using a 0 to 100 VAS, with a higher score reflects a better outcome.

  11. Eating habits assessment - Food preferences

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

    Leeds Food Preference Questionnaire (LFPQ). The questionnaire involves an explicit evaluation of "liking" and "wanting" for 16 food items that can be categorized as high-fat savory (HFSA), low-fat savory (LFSA), high-fat sweet (HFSW) and low-fat sweet (LFSW). Each food image is scored on a 100-mm VAS, while a higher score indicates a stronger preference for that food category. The second sub-task evaluates "implicit wanting" and requires rapid choice between 96 paired combinations of the food images from different categories

  12. Anthropometric measures - height (cm)

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

    (cm) by altimeter

  13. Body composition- percentage of body fat (BF%)

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

    Body composition analysis using Inbody370S®

  14. Body composition - fat-free mass (kg)

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

    Body composition analysis using Inbody370S®

  15. Body composition - skeletal muscle mass (kg)

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

    Body composition analysis using Inbody370S®

Other outcomes

  1. Biochemical tests

    Time frame: At baseline

    Participants will be asked to provide at T0 biochemical tests obtained during the last 3 months, including complete blood count, lipid profile, fasting glucose, HbA1c, iron, transferrin, ferritin, vitamin B12, folate, vitamin D, albumin and total protein

  2. Demographics - age

    Time frame: At baseline

    years

  3. Demographics - marital status

    Time frame: At baseline

    married, single, divorced or widowed

  4. Demographics - education

    Time frame: At baseline

    less than high school, high school graduate, high school diploma, bachelors degree, masters degree, MD or doctoral degree

  5. Demographics - occupation status

    Time frame: At baseline

    employee full time, employee part time, self-employed or other

  6. Health status - Number of participants with coexisting medical conditions and their types

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

    T2DM, prediabetes, dyslipidemia, HTN,sleep apnea, orthopedic problems, GERD, mental disorder or other

  7. Number of participants using regular medications and their types

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

    usual medications

  8. Smoking habits

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

    smoker, former smoker or never

  9. Number of participants using supplementation and their Types

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

    multiviamin, Iron, vitamin D, folic acid, vitamin B12, calcium or other

  10. Lifestyle factors - Sleeping habits

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

    sleeping quality on a scale of 0-3 (0- very good, 1-quite good, 2- quite bad, 3- very bad)

  11. Lifestyle factors - frequency of physical activity

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

    number of exercises per week

  12. Lifestyle factors - duration of physical activity

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

    exercise time in minutes

  13. Lifestyle factors - type of physical activity

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

    aerobic or anaerobic

Study contacts

Contact information is provided by the study sponsor or research team.

Rotem Refaeli

CONTACT

[email protected]

+972545797995

Shiri Sherf-dagan, Ph.D

CONTACT

[email protected]

+972747288004

Sponsors and collaborators

Lead sponsor

Ariel University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2024
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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