Comparing Mediterranean and High Protein/Low Carb Diets for Obese Patients on Semaglutide
The Effect of Mediterranean or High Protein/Low Carbohydrate Diet on Arterial Stiffness in Non-diabetic, Obese Patients on Semaglutide: A Randomized Controlled Trial
This study is testing whether a Mediterranean diet or a high protein/low carb diet can help Lebanese adults with obesity improve their health while using Semaglutide for weight loss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | American University of Beirut Medical Center Academic / other |
| Locations | 1 site (Beirut, Riad El Solh) |
| Trial ID | NCT04990024 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of two different dietary approaches, the Mediterranean diet and a high protein/low carbohydrate diet, on arterial stiffness and metabolic indicators in obese patients starting Semaglutide for weight management. The study will involve Lebanese adults aged 18-49 with obesity, who will be randomized into one of the two diet groups for a duration of six months. Key measurements will include arterial stiffness assessed by carotid-femoral pulse wave velocity and changes in visceral adipose tissue. Participants will be recruited from the Endocrine clinics at the American University of Beirut Medical Center and nearby clinics.
Who should consider this trial
Good fit: Ideal candidates are men and premenopausal women aged 18-49 with obesity (BMI ≥ 30 kg/m2) who are starting Semaglutide for weight management.
Not a fit: Patients with diabetes, uncontrolled hypertension, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal dietary strategies for improving cardiovascular health in obese patients undergoing weight management with Semaglutide.
How similar studies have performed: While similar dietary interventions have been explored, this specific comparison in the context of Semaglutide is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beirut, Riad El Solh
- American University of Beirut - Medical Center — Beirut, Riad El Solh, Lebanon (Recruiting)
Study contacts
- Principal investigator: Marlene Chakhtoura, MD, MSc — American University of Beirut Medical Center
- Study coordinator: Marlene Chakhtoura, MD, MSc
- Email: mc39@aub.edu.lb
- Phone: +9611350000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.