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

Overview

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).

Interventions

• Behavioral nutritional intervention
  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

Primary outcome measures

• Gastrointestinal symptoms assessment [Time frame: Baseline and at the end of the study period (20 weeks)]
• Defecation texture [Time frame: Baseline and at the end of the study period (20 weeks)]
• Bowel Movement (BM) frequency [Time frame: Baseline and at the end of the study period (20 weeks)]
• 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)]

Secondary outcome measures (12)

• Incretin-based AOM treatment discontinuation rate [Time frame: At the end of the study period (20 weeks) and weekly until 20 weeks]
• Anthropometric measures - weight [Time frame: Change from baseline at the end of the study period (20 weeks)]
• Anthropometric measures - waist circumference (WC) [Time frame: Change from baseline at the end of the study period (20 weeks)]
• Body composition - fat mass (kg) [Time frame: Change from baseline at the end of the study period (20 weeks)]
• Dietary intake [Time frame: Change from baseline at the end of the study period (20 weeks)]
• Eating habits assessment [Time frame: Change from baseline at the end of the study period (20 weeks)]
• Eating habits assessment - Control of Eating [Time frame: Change from baseline at the end of the study period (20 weeks)]
• Functional parameters - muscle strength [Time frame: Change from baseline at the end of the study period (20 weeks)]
• Functional parameters- leg strength and endurance [Time frame: Change from baseline at the end of the study period (20 weeks)]
• Quality of life assessment [Time frame: Change from baseline at the end of the study period (20 weeks)]
• Eating habits assessment - Food preferences [Time frame: Change from baseline at the end of the study period (20 weeks)]
• Anthropometric measures - height (cm) [Time frame: Change from baseline at the end of the study period (20 weeks)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Israel · 3 centers

• Ariel University — Ariel
• Rabin Medical Center, Beilinson Hospital — Petah Tikva
• Assuta Medical Center — Tel Aviv

Identifiers

NCT: NCT06431308 · ASMC-0003-24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗