Clinical trial NCT06431308: Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events
Official title: Adjuvant Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events During the Up-titration Phase
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity; Drug
Lead sponsor: Ariel University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Gastrointestinal symptoms assessment
timeFrame: Baseline and at the end of the study period (20 weeks)
measure: Defecation texture
timeFrame: Baseline and at the end of the study period (20 weeks)
measure: Bowel Movement (BM) frequency
timeFrame: Baseline and at the end of the study period (20 weeks)
measure: Participants gastrointestinal symptoms report
timeFrame: Baseline, at the end of the study period (20 weeks) and weekly until 20 weeks (for subjective GI symptoms report only)
Secondary outcomes:
measure: Incretin-based AOM treatment discontinuation rate
timeFrame: At the end of the study period (20 weeks) and weekly until 20 weeks
measure: Anthropometric measures - weight
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Anthropometric measures - waist circumference (WC)
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Body composition - fat mass (kg)
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Dietary intake
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Eating habits assessment
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Eating habits assessment - Control of Eating
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Functional parameters - muscle strength
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Functional parameters- leg strength and endurance
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Quality of life assessment
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Eating habits assessment - Food preferences
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Anthropometric measures - height (cm)
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Body composition- percentage of body fat (BF%)
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Body composition - fat-free mass (kg)
timeFrame: Change from baseline at the end of the study period (20 weeks)
measure: Body composition - skeletal muscle mass (kg)
timeFrame: Change from baseline at the end of the study period (20 weeks)
Other outcomes:
measure: Biochemical tests
timeFrame: At baseline
measure: Demographics - age
timeFrame: At baseline
measure: Demographics - marital status
timeFrame: At baseline
measure: Demographics - education
timeFrame: At baseline
measure: Demographics - occupation status
timeFrame: At baseline
measure: Health status - Number of participants with coexisting medical conditions and their types
timeFrame: Baseline and at the end of the study period (20 weeks)
measure: Number of participants using regular medications and their types
timeFrame: Baseline and at the end of the study period (20 weeks)
measure: Smoking habits
timeFrame: Baseline and at the end of the study period (20 weeks)
measure: Number of participants using supplementation and their Types
timeFrame: Baseline and at the end of the study period (20 weeks)
measure: Lifestyle factors - Sleeping habits
timeFrame: Baseline and at the end of the study period (20 weeks)
measure: Lifestyle factors - frequency of physical activity
timeFrame: Baseline and at the end of the study period (20 weeks)
measure: Lifestyle factors - duration of physical activity
timeFrame: Baseline and at the end of the study period (20 weeks)
measure: Lifestyle factors - type of physical activity
timeFrame: Baseline and at the end of the study period (20 weeks)
Locations:
city: Ariel
country: Israel
facility: Ariel University
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
Study officials:
References: