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NCT Number: NCT04990024

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

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American University of Beirut - Medical Center

Beirut, Riad El Solh, 1107 2020, Lebanon

Location status: Recruiting

Location contact

AUBMC

CONTACT

[email protected]

+961350000

Marlene Chakhtoura, MD, MSc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention Med Diet

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.

Dietary Intervention HP/LC Diet

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.

Primary outcomes

  1. cfPWV measurement and pulse wave analysis (PWA) using SphygmoCorCvMS V9 (AtCor Medical)

    Time frame: 6 months after enrollment

    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.

Secondary outcomes

  1. Body composition - visceral adipose tissue using dual x-ray absorptiometry (DXA)

    Time frame: 6 months after enrollment

    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.

  2. Body composition - percent fat-free body mass using dual x-ray absorptiometry (DXA)

    Time frame: 6 months after enrollment

    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.

  3. Body composition - percent body fat using dual x-ray absorptiometry (DXA)

    Time frame: 6 months after enrollment

    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.

Other outcomes

  1. Dietary Assessment using 24-hour recalls

    Time frame: 6 months after enrollment

    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.

  2. Dietary Assessment using adherence questionnaires

    Time frame: 6 months after enrollment

    During the individual sessions, brief adherence assessment questionnaires for each diet, adapted from PREDIMED protocol, will be administered to calculate dietary adherence scores.

  3. Anthropometric measurements - weight in kilograms, height in centimetres, aggregated into BMI (kilogram per meter squared).

    Time frame: 6 months after enrollment

    Weight and height will be measured following standard operating procedures (SOP) and BMI will be computed by dividing weight by height squared.

  4. Anthropometric measurements - waist and hip circumference in centimetres, aggregated into waist to hip ratio ratio

    Time frame: 6 months after enrollment

    Waist and hip circumference will be measured following standard operating procedures (SOP).

  5. Vital signs - blood pressure

    Time frame: 6 months after enrollment

    Blood pressure will be measured following standard operating procedures (SOP).

  6. Vital signs - heart rate

    Time frame: 6 months after enrollment

    Heart rate will be measured following standard operating procedures (SOP).

  7. Genetic studies

    Time frame: 6 months after enrollment

    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.

  8. Metabolic, inflammatory and appetite hormones in pg/mL

    Time frame: 6 months after enrollment

    Gastric inhibitory polypeptide (GIP), Leptin, Adiponectin, Orexin, IL6. These tests will be run at the endocrine core research Lab in batches at study completion.

  9. Metabolic, inflammatory and appetite hormones in pmol/L

    Time frame: 6 months after enrollment

    Insulin and Ghrelin.These tests will be run at the endocrine core research Lab in batches at study completion.

  10. Metabolic, inflammatory and appetite hormones in ng/mL

    Time frame: 6 months after enrollment

    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.

  11. Quality of Life Measurement as assessed by the SF-36 questionnaire

    Time frame: 6 months after enrollment

    SF-36 questionnaire filled by participant

Study contacts

Contact information is provided by the study sponsor or research team.

Marlene Chakhtoura, MD, MSc

CONTACT

[email protected]

+9611350000 ext. 7411

Rachelle El Haber, BSc

CONTACT

[email protected]

+9611350000 ext. 8314

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

The Effect of Mediterranean or High Protein/Low Carbohydrate Diet on Arterial Stiffness in Non-diabetic, Obese Patients on Semaglutide: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2021
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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