Obesity; DrugNCT06431308
Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events
A study testing nutritional intervention in people with Obesity; Drug, run by Ariel University at 3 sites in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity; Drug
- What is being tested?
- nutritional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesIsrael
- Study dates
- 30 Jan 2025to 5 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Ariel University
Ariel, 40700
Rabin Medical Center, Beilinson Hospital
Petah Tikva, 4941492
Assuta Medical Center
Tel Aviv, Israel, 6971028
About this study
Official title: Adjuvant Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events During the Up-titration Phase
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.
Read more
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).
- Conditions
- Obesity; Drug
- Being tested
- nutritional intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional interventionBehavioural
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 . 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. 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.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional intervention group | Experimental | Nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). Receives: Behavioral: nutritional intervention |
| Control group | No intervention | * Usual nutrition care treatment for patients treated with Wegovy© or Mounjaro© (RCT). * Prior to the initiation of AOM treatment, participant will receive general nutrition guidance based on national recommendations according to the Mediterranean diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at the end of the study period (20 weeks)
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
Measured: Baseline and at the end of the study period (20 weeks)
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
Measured: Baseline and at the end of the study period (20 weeks)
Participants gastrointestinal symptoms report
Participant subjective and objective reporting of GI symptoms
Measured: Baseline, at the end of the study period (20 weeks) and weekly until 20 weeks (for subjective GI symptoms report only)
Secondary outcomes (15)
Incretin-based AOM treatment discontinuation rate
Measured: At the end of the study period (20 weeks) and weekly until 20 weeks
Anthropometric measures - weight
Weight (kg) by digital scale
Measured: Change from baseline at the end of the study period (20 weeks)
Anthropometric measures - waist circumference (WC)
will be measured by tape measure (cm)
Measured: Change from baseline at the end of the study period (20 weeks)
Body composition - fat mass (kg)
Body composition analysis using Inbody370S®
Measured: Change from baseline at the end of the study period (20 weeks)
Dietary intake
24-hour dietary recall (24HR)
Measured: Change from baseline at the end of the study period (20 weeks)
Eating habits assessment
General questions regarding eating patterns, hydration and foods intolerance
Measured: Change from baseline at the end of the study period (20 weeks)
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.
Measured: Change from baseline at the end of the study period (20 weeks)
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©)
Measured: Change from baseline at the end of the study period (20 weeks)
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.
Measured: Change from baseline at the end of the study period (20 weeks)
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.
Measured: Change from baseline at the end of the study period (20 weeks)
Eating habits assessment - Food preferences
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
Measured: Change from baseline at the end of the study period (20 weeks)
Anthropometric measures - height (cm)
(cm) by altimeter
Measured: Change from baseline at the end of the study period (20 weeks)
Body composition- percentage of body fat (BF%)
Body composition analysis using Inbody370S®
Measured: Change from baseline at the end of the study period (20 weeks)
Body composition - fat-free mass (kg)
Body composition analysis using Inbody370S®
Measured: Change from baseline at the end of the study period (20 weeks)
Body composition - skeletal muscle mass (kg)
Body composition analysis using Inbody370S®
Measured: Change from baseline at the end of the study period (20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start30 Jan 2025
- Primary completion5 Aug 2026
- Study completion5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity; DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiri Sherf Dagan, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431308
- Sponsor's protocol ID
- ASMC-0003-24
- Status last verified
- Oct 2026
- First submitted
- 28 Mar 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events During the Up-titration Phase
- ClinicalTrials.gov ID
- NCT06431308
- Acronym / sponsor ID
- ASMC-0003-24
- Conditions
- Obesity; Drug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional intervention group | Experimental | Behavioral: nutritional interventionNutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). |
| Control group | No intervention | –* Usual nutrition care treatment for patients treated with Wegovy© or Mounjaro© (RCT). * Prior to the initiation of AOM treatment, participant will receive general nutrition guidance based on national recommendations according to the Mediterranean diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional interventionA 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 . 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. 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. | Behavioural | Nutritional intervention group |
Primary outcome
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.
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
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
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
15 secondary outcomes
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)
Body composition- percentage of body fat (BF%)
Time frame: Change from baseline at the end of the study period (20 weeks)
Body composition - fat-free mass (kg)
Time frame: Change from baseline at the end of the study period (20 weeks)
Body composition - skeletal muscle mass (kg)
Time frame: Change from baseline at the end of the study period (20 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional intervention in people with Obesity; Drug, run by Ariel University at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal symptoms assessment (time frame: Baseline and at the end of the study period (20 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.