Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events
- Conditions
- Obesity; Drug
- Interventions
- Behavioral: nutritional intervention
- Registration Number
- NCT06431308
- Lead Sponsor
- Ariel University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutritional intervention group nutritional intervention Nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s).
- Primary Outcome Measures
Name Time Method Defecation texture 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
Participants gastrointestinal symptoms report 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
Gastrointestinal symptoms assessment 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.
Bowel Movement (BM) frequency 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
- Secondary Outcome Measures
Name Time Method 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) Weight (kg) by digital scale
Anthropometric measures - waist circumference (WC) Change from baseline at the end of the study period (20 weeks) will be measured by tape measure (cm)
Body composition - fat mass (kg) Change from baseline at the end of the study period (20 weeks) Body composition analysis using Inbody370S®
Dietary intake Change from baseline at the end of the study period (20 weeks) 24-hour dietary recall (24HR)
Eating habits assessment Change from baseline at the end of the study period (20 weeks) General questions regarding eating patterns, hydration and foods intolerance
Eating habits assessment - Control of Eating 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.
Functional parameters - muscle strength 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©)
Functional parameters- leg strength and endurance 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.
Quality of life assessment 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.
Eating habits assessment - Food preferences 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
Anthropometric measures - height (cm) Change from baseline at the end of the study period (20 weeks) (cm) by altimeter
Body composition- percentage of body fat (BF%) Change from baseline at the end of the study period (20 weeks) Body composition analysis using Inbody370S®
Body composition - fat-free mass (kg) Change from baseline at the end of the study period (20 weeks) Body composition analysis using Inbody370S®
Body composition - skeletal muscle mass (kg) Change from baseline at the end of the study period (20 weeks) Body composition analysis using Inbody370S®
Trial Locations
- Locations (3)
Rabin Medical Center, Beilinson Hospital
🇮🇱Petah Tikva, Israel
Ariel University
🇮🇱Ariel, Israel
Assuta Medical Center
🇮🇱Tel Aviv, Israel