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

Obesity; Drug Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06431308
• Other study ID #: ASMC-0003-24
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2024
• Source: Ariel University
• Contact: Shiri Sherf-dagan, Ph.D
• Phone: +972747288004
• Email: shiris[@]ariel.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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©. 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© titration phase [20 weeks (T1)] and weekly during the study period (for GI symptoms assessment).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 for treatment with Wegovy© [i.e., personal or family history of medullary thyroid cancer (MTC), personal history of multiple endocrine neoplasia type 2 (MEN2) syndrome, a history of acute pancreatitis from an unknown etiology, attempting conception, current pregnancy or breastfeeding]
• previous bariatric surgery or endo-bariatric procedure
• history of chronic pancreatitis
• treatment with AOM within 6 months 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 (32). In addition, Participants who will decide not to initiate or stop Wegovy© treatment for a period of more than two consecutive weeks for any reason or who undergo bariatric surgery or endoscopic sleeve gastroplasty during the study period will be excluded from the study.

Related Conditions & MeSH terms

• Obesity
• Obesity; Drug

Intervention

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 recommendations will be sent. 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. 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

Locations

Country	Name	City	State
Israel	Ariel University	Ariel

Sponsors (1)

Lead Sponsor	Collaborator
Ariel University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biochemical tests	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, and vitamin D	At baseline
Other	Demographics - age	years	At baseline
Other	Demographics - marital status	married, single, divorced or widowed	At baseline
Other	Demographics - education	less than high school, high school graduate, high school diploma, bachelors degree, masters degree, MD or doctoral degree	At baseline
Other	Demographics - occupation status	employee full time, employee part time, self-employed or other	At baseline
Other	Health status - Number of participants with coexisting medical conditions and their types	T2DM, prediabetes, dyslipidemia, HTN,sleep apnea, orthopedic problems, GERD, mental disorder or other	Baseline and at the end of the study period (20 weeks)
Other	Number of participants using regular medications and their types	usual medications	Baseline and at the end of the study period (20 weeks)
Other	Smoking habits	smoker, former smoker or never	Baseline and at the end of the study period (20 weeks)
Other	Number of participants ysing supplementation and their Types	multiviamin, Iron, vitamin D, folic acid, vitamin B12, calcium or other	Baseline and at the end of the study period (20 weeks)
Other	Lifestyle factors - Sleeping habits	sleeping quality on a scale of 0-3 (0- very good, 1-quite good, 2- quite bad, 3- very bad)	Baseline and at the end of the study period (20 weeks)
Other	Lifestyle factors - frequency of physical activity	number of exercises per week	Baseline and at the end of the study period (20 weeks)
Other	Lifestyle factors - duration of physical activity	exercise time in minutes	Baseline and at the end of the study period (20 weeks)
Other	Lifestyle factors - type of physical activity	aerobic or anaerobic	Baseline and at the end of the study period (20 weeks)
Primary	Gastrointestinal symptoms assessment	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.	Baseline and at the end of the study period (20 weeks)
Primary	Defecation texture	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	Baseline and at the end of the study period (20 weeks)
Primary	Bowel Movement (BM) frequency	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	Baseline and at the end of the study period (20 weeks)
Primary	Participants gastrointestinal symptoms report	Participant subjective and objective reporting of GI symptoms	Baseline, at the end of the study period (20 weeks) and weekly until 20 weeks (for subjective GI symptoms report only)
Secondary	Incretin-based AOM treatment discontinuation rate		At the end of the study period (20 weeks) and weekly until 20 weeks
Secondary	Anthropometric measures - BMI	Weight (kg) by digital scale, height (cm) by altimeter. weight and height will be combined to report BMI in kg/(meter)^2	Change from baseline at the end of the study period (20 weeks)
Secondary	Anthropometric measures - waist circumference (WC)	will be measured by tape measure (cm)	Change from baseline at the end of the study period (20 weeks)
Secondary	Body composition	Body composition analysis using Inbody370S® includes measuring of fat mass (kg) , percentage of body fat (BF%), fat-free mass (kg), and skeletal muscle mass (kg).	Change from baseline at the end of the study period (20 weeks)
Secondary	Dietary intake	3-days food diaries and Israeli Ministry of Health Food Frequency Questionnaire (FFQ) that will be modified for the current study population	Change from baseline at the end of the study period (20 weeks)
Secondary	Eating habits assessment	General questions regarding eating patterns, hydration and foods intolerance	Change from baseline at the end of the study period (20 weeks)
Secondary	Eating habits assessment - Control of Eating	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.	Change from baseline at the end of the study period (20 weeks)
Secondary	Functional parameters - muscle strength	Handgrip (HG) muscle Strength - measure static muscle strength (kg) of the upper extremities by a digital hand dynamometer (Jamar plus digital©)	Change from baseline at the end of the study period (20 weeks)
Secondary	Functional parameters- leg strength and endurance	30-seconds sit and stand test - counts the number of times the patient stands in 30 seconds. Higher scores means a better outcome.	Change from baseline at the end of the study period (20 weeks)
Secondary	Quality of life assessment	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.	Change from baseline at the end of the study period (20 weeks)