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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Other: Dietary Intervention Med Diet; Other: Dietary Intervention HP/LC Diet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marlene Chakhtoura, MD, MSc; Phone Number: 7411 +9611350000; Email: mc39@aub.edu.lb
• Study Contact Backup: Name: Rachelle El Haber, BSc; Phone Number: 8314 +9611350000; Email: re136@aub.edu.lb

Study Locations

• Lebanon
  • Riad El Solh
    • Beirut, Riad El Solh, Lebanon, 1107 2020
      • Recruiting
      • American University of Beirut - Medical Center
      • Contact: AUBMC; Phone Number: +961350000; Email: aubmc@aub.edu.lb
      • Principal Investigator: Marlene Chakhtoura, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after enrollment
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.	6 months after enrollment
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.	6 months after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after enrollment
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.	6 months after enrollment
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.	6 months after enrollment
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).	6 months after enrollment
Vital signs - blood pressure	Blood pressure will be measured following standard operating procedures (SOP).	6 months after enrollment
Vital signs - heart rate	Heart rate will be measured following standard operating procedures (SOP).	6 months after enrollment
Genetic studies	Genetic studies will consist of Single Nucleoside Polymorphism (SNP) analysis of genes of the GLP1 receptors and cannabinoid receptor 1 will be performed in the molecular lab. These tests will be run at the endocrine core research Lab in batches at study completion.	6 months after enrollment
Metabolic, inflammatory and appetite hormones in pg/mL	Gastric inhibitory polypeptide (GIP), Leptin, Adiponectin, Orexin, IL6. These tests will be run at the endocrine core research Lab in batches at study completion.	6 months after enrollment
Metabolic, inflammatory and appetite hormones in pmol/L	Insulin and Ghrelin.These tests will be run at the endocrine core research Lab in batches at study completion.	6 months after enrollment
Metabolic, inflammatory and appetite hormones in ng/mL	Irisin and mineral hormones and markers, including Crosslaps, Osteocalcin, GLP1. These tests will be run at the endocrine core research Lab in batches at study completion.	6 months after enrollment
Quality of Life Measurement as assessed by the SF-36 questionnaire	SF-36 questionnaire filled by participant	6 months after enrollment

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Marlene Chakhtoura, MD, MSc, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): September 15, 2025

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 3, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: BIO-2020-0136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No