The Effect of Different Diets on Arterial Stiffness in Obese Patients on Semaglutide
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-49
SponsorAmerican University of Beirut Medical Center
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary Intervention Med Diet
Other interventionThe 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.
Dietary Intervention HP/LC Diet
Other interventionThis 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Mediterranean DietExperimental treatment 1 intervention
Group B: High Protein/Low Carbohydrate DietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
cfPWV measurement and pulse wave analysis (PWA) using SphygmoCorCvMS V9 (AtCor Medical)
Measured by an RA or a technician, based on the American Heart Association Council recommendations on arterial stiffness measurement in research. The distance from the suprasternal notch to the carotid pulse, and to the femoral site on the same side will be measured; the former distance is subtracted from the latter one. Ten seconds of carotid and 10 seconds of femoral arterial waveforms will be recorded, and the average of the data will be obtained for each of the sites.
Time frame
6 months after enrollmentSecondary outcomes
1
Body composition - visceral adipose tissue using dual x-ray absorptiometry (DXA)
Measured by an RA or a technician, assessed using dual x-ray absorptiometry (DXA), Hologic machine, version 13.6.0.5, the preferred method for the assessment of body composition. The ISCD recommendations will be followed for body composition measurement.
Time frame
6 months after enrollment2
Body composition - percent fat-free body mass using dual x-ray absorptiometry (DXA)
Measured by an RA or a technician, assessed using dual x-ray absorptiometry (DXA), Hologic machine, version 13.6.0.5, the preferred method for the assessment of body composition. The ISCD recommendations will be followed for body composition measurement.
Time frame
6 months after enrollment3
Body composition - percent body fat using dual x-ray absorptiometry (DXA)
Measured by an RA or a technician, assessed using dual x-ray absorptiometry (DXA), Hologic machine, version 13.6.0.5, the preferred method for the assessment of body composition. The ISCD recommendations will be followed for body composition measurement.
Time frame
6 months after enrollmentOther outcomes
1
Dietary Assessment using 24-hour recalls
Three-repeated 24-hour recalls (24 HR) administered via phone (2-week days and one week-end day, during one specific week). During the phone call, the participant will be asked to recall all what she/he has consumed during the past 24 hours, and the multiple pass approach of the USDA will be adopted.
Time frame
6 months after enrollment2
Dietary Assessment using adherence questionnaires
During the individual sessions, brief adherence assessment questionnaires for each diet, adapted from PREDIMED protocol, will be administered to calculate dietary adherence scores.
Time frame
6 months after enrollment3
Anthropometric measurements - weight in kilograms, height in centimetres, aggregated into BMI (kilogram per meter squared).
Weight and height will be measured following standard operating procedures (SOP) and BMI will be computed by dividing weight by height squared.
Time frame
6 months after enrollment4
Anthropometric measurements - waist and hip circumference in centimetres, aggregated into waist to hip ratio ratio
Waist and hip circumference will be measured following standard operating procedures (SOP).
Time frame
6 months after enrollmentSponsors and contacts
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Source ClinicalTrials.gov