The Effect of Different Diets on Arterial Stiffness in Obese Patients on Semaglutide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2025-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In patients initiating Semaglutide for weight management, the objective is to compare the effect of the Mediterranean diet and the high protein/low carbohydrate (HP/LC) diet CV parameters, namely arterial stiffness, measured by carotid-femoral pulse wave velocity (cfPWV), and visceral adipose tissue, in addition to other metabolic indicators.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of a Low-carbohydrate Diet on Weight Loss in People Using the Injectable GLP-1 Agonist Semaglutide for Weight Loss: a Pilot Trial

NCT07280403

Weight Loss

ACTIVE_NOT_RECRUITING NA

A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity

NCT03842202

Overweight Obesity

COMPLETED PHASE1

A Research Study to Compare How Much Semaglutide is Found in the Blood With Different Tablets of Oral Semaglutide in Healthy Participants

NCT05784402

Healthy Participants

COMPLETED PHASE1

Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

NCT03548987

Metabolism and Nutrition Disorder Obesity

COMPLETED PHASE3

Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medications Affect the Amount of Food Left in the Stomach in People Using Liraglutide (Injected), Semaglutide (Taken by Mouth) or Semaglutide (Injected)

NCT07225816

Obesity

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a 6-month open label pilot RCT that will be conducted on Lebanese subjects with obesity, upon the initiation of Semaglutide for medical weight management, as recommended by their physician. Patients will be randomized to 2 treatment arms: Med diet and HP/LC diet. Med diet will be hypocaloric, allowing the same energy restriction, of 500 Kcal/d, while the HP/LC diet will be ad libitum. Participants will be recruited from the Endocrine clinics at AUB-MC, and from satellite clinic next in Beirut. Brochures and posters of the trial will be available in the clinic waiting areas. Patients of both participating and non-participating physicians will be recruited in the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Weight Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A computer-generated allocation sequence will be used, with a permuted block randomization (1:1). The biostatistician (MB) will generate the randomization sequence and will share it with a trial coordinator (MR) who is independent of the study team. Upon the recruitment of every participant, the study RA will contact the independent trial coordinator to receive the randomization code, in an opaque and sealed envelope.

Randomization will take place at 1-30 days after starting Semaglutide. Treatment allocation will be in batches at the end of each month.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The design is open label as it is impossible to blind the participants and the research team for the study intervention. Each of the dietary interventions will be delivered in the format of intensive individual sessions about the diet, food selection and food recipes. Outcome assessors will be blind to the intervention

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mediterranean Diet

30 participants will be randomized to this arm. The intervention consists of 8 visits, over a period of 24 weeks, including 6 individual educational sessions on Mediterranean diet in patients on Semaglutide and 2 reinforcement educational sessions towards the end of the trial. Dietary assessments and adherence questionnaires will be conducted on several visits to assess adherence.

Group Type EXPERIMENTAL

Dietary Intervention Med Diet

Intervention Type OTHER

The diet will consist of a calorie-restricted Med diet, with 500 Kcal/d energy restriction. The intervention consists of individual and reinforcement sessions on Med diet. During these sessions, the RA will go over the benefits of Med diet, what composition it should have, and how to make appropriate choices for meal planning, in addition to providing food lists, by season. The individual sessions with subjects will also allow to individualize the diet plan.

High Protein/Low Carbohydrate Diet

30 participants will be randomized to this arm. The intervention consists of 8 visits, over a period of 24 weeks, including 6 individual educational sessions on High Protein/Low Carbohydrate diet in patients on Semaglutide and 2 reinforcement educational sessions towards the end of the trial. Dietary assessments and adherence questionnaires will be conducted on several visits to assess adherence.

Group Type EXPERIMENTAL

Dietary Intervention HP/LC Diet

Intervention Type OTHER

This is a non-ketogenic diet consisting of ad libitum intake of proteins, fat, and vegetables, with restriction of daily carbohydrates to \<130 g/d. The intervention consists of individual and reinforcement educational sessions on HP/LC, same as with Med diet (above). The individual sessions with subjects will also allow to individualize the diet plan.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary Intervention Med Diet

The diet will consist of a calorie-restricted Med diet, with 500 Kcal/d energy restriction. The intervention consists of individual and reinforcement sessions on Med diet. During these sessions, the RA will go over the benefits of Med diet, what composition it should have, and how to make appropriate choices for meal planning, in addition to providing food lists, by season. The individual sessions with subjects will also allow to individualize the diet plan.

Intervention Type OTHER

Dietary Intervention HP/LC Diet

This is a non-ketogenic diet consisting of ad libitum intake of proteins, fat, and vegetables, with restriction of daily carbohydrates to \<130 g/d. The intervention consists of individual and reinforcement educational sessions on HP/LC, same as with Med diet (above). The individual sessions with subjects will also allow to individualize the diet plan.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men and premenopausal women, 18-49 years, with obesity defined as BMI ≥ 30 kg/m2
* Upon the initiation of Semaglutide (within the first 1-4 weeks) for medical weight management, for clinical purposes, as advised by the primary physician
* Able to commit for a 6-month trial visits

Exclusion Criteria

* Pregnant women
* Patients who are taking or have taken other weight reducing drug therapies in the previous 6 months
* Patients who have undergone metabolic weight loss surgery
* Patients known to have diabetes (HbA1c ≥6.5% at screening)
* Patients with uncontrolled hypertension
* Patients with uncontrolled cardiac disease, pulmonary, renal or liver diseases, active cancer or psychiatric diseases
* Patients with excessive alcohol intake, defined as ≥ 2 glasses per day
* Patients known to have uncontrolled/ untreated thyroid disorders.
* Patients with cushing disease or polycystic ovaries, and those with neuro-endocrine or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy): Such patients are resistant to weight loss, and they need treatment of their primary disease and/or cessation of the culprit medication to lose weight
* Patients with untreated gout
* Patients who have undergone bariatric surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes