RecruitingNot ApplicableNCT04990024

The Effect of Different Diets on Arterial Stiffness in 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

Sponsor

American University of Beirut Medical Center

Enrollment

60 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

Obesity Weight Loss

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 49 Years

Inclusion Criteria3

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 Criteria11

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

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Interventions

OTHERDietary 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.

OTHERDietary 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.