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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Diet | Experimental | 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. |
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| High Protein/Low Carbohydrate Diet | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marlene Chakhtoura, MD, MSc | Contact | +9611350000 | 7411 | mc39@aub.edu.lb |
| Rachelle El Haber, BSc | Contact | +9611350000 | 8314 | re136@aub.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Marlene Chakhtoura, MD, MSc | American University of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut - Medical Center | Recruiting | Beirut | Riad El Solh | 1107 2020 | Lebanon |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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A computer-generated allocation sequence will be used, with a permuted block randomization (1:1). The biostatistician (MB) will generate the randomization sequence and will share it with a trial coordinator (MR) who is independent of the study team. Upon the recruitment of every participant, the study RA will contact the independent trial coordinator to receive the randomization code, in an opaque and sealed envelope.
Randomization will take place at 1-30 days after starting Semaglutide. Treatment allocation will be in batches at the end of each month.
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The design is open label as it is impossible to blind the participants and the research team for the study intervention. Each of the dietary interventions will be delivered in the format of intensive individual sessions about the diet, food selection and food recipes. Outcome assessors will be blind to the intervention
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| 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. |
|
| 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 |
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |