Adjuvant Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events During the Up-titration Phase
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ariel University
- Enrollment
- 120
- Locations
- 6
- Primary Endpoint
- Defecation texture
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
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
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.
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
Secondary Outcomes
- 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))
- Eating habits assessment(Change from baseline at the end of the study period (20 weeks))
- Eating habits assessment - Control of Eating(Change from baseline at the end of the study period (20 weeks))
- Functional parameters - muscle strength(Change from baseline at the end of the study period (20 weeks))
- Functional parameters- leg strength and endurance(Change from baseline at the end of the study period (20 weeks))
- Quality of life assessment(Change from baseline at the end of the study period (20 weeks))
- Eating habits assessment - Food preferences(Change from baseline at the end of the study period (20 weeks))
- Anthropometric measures - height (cm)(Change from baseline at the end of the study period (20 weeks))
- Body composition- percentage of body fat (BF%)(Change from baseline at the end of the study period (20 weeks))
- Body composition - fat-free mass (kg)(Change from baseline at the end of the study period (20 weeks))
- Body composition - skeletal muscle mass (kg)(Change from baseline at the end of the study period (20 weeks))
Investigators
Shiri Sherf Dagan
Principal Investigator
Ariel University