NCT06881706

Brief Summary

This study evaluated the effects of a weight loss diet on biochemical, anthropometric variables, and cluster of differentiation 36 (CD36) levels in 65 patients newly diagnosed with metabolic syndrome (MetS). Participants followed an 8-week medical nutrition therapy (MNT) designed to achieve at least 5% weight loss. Significant changes were observed in some biochemical parameters and blood pressure among those who adhered to the diet. CD36 levels showed correlations with various metabolic and body composition parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

February 25, 2025

Last Update Submit

March 11, 2025

Conditions

Keywords

metabolic syndromeweight losscd36fatty acidsfatty acid receptor

Outcome Measures

Primary Outcomes (1)

  • Change in the intervention group

    A decrease in body weight, improvement in biochemical findings and a decrease in serum CD36 levels are expected in individuals who follow the given diet.

    Week 0 - Week 8

Study Arms (2)

Intervention Group

EXPERIMENTAL

At the beginning of the study, all participants were given a hypocaloric diet to induce weight loss. Individuals who followed the diet and lost at least 5% of their starting weight constituted this group.

Other: medical nutrition therapy

Control Group

NO INTERVENTION

At the beginning of the study, all participants were given a hypocaloric diet to induce weight loss. Individuals who did not follow the diet and did not lose at least 5% of their starting weight constituted this group.

Interventions

Medical nutrition treatment was planned for all participants with metabolic syndrome. A diet plan was created considering age, gender, blood findings and nutritional habits. Individuals with MetS were given a weight loss diet planned at the basal energy level calculated with the Harris-Benedict equation and applied for 8 weeks. Individuals who applied the weight loss diet were targeted to lose at least 5% of their initial weight at the end of 8 weeks. Individuals who strictly followed the given medical nutrition treatment and achieved the targeted weight loss formed the intervention group, and individuals who did not follow the medical nutrition treatment formed the control group. At the end of the 8 weeks, all parameters, blood pressure and anthropometric measurements of all individuals who participated in the study and retrospective 24-hour food consumption records were recorded again and the study was concluded.

Also known as: hypocaloric diet intervention, weight loss intervention
Intervention Group

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 19-64
  • Being diagnosed with MetS by a physician according to the International Diabetes Federation (IDF)-2005 metabolic syndrome diagnostic criteria
  • Being a volunteer to participate in the study

You may not qualify if:

  • Being pregnant and breastfeeding
  • Smoking and drinking alcohol
  • Having any chronic disease other than metabolic syndrome
  • Taking regular medication
  • Taking regular nutritional supplements
  • Having a change in weight within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, Altınordu, 52200, Turkey (Türkiye)

Location

Related Publications (14)

  • Khaleel AA, Al-Barzinji RMGT. Soluble CD36 Concentration in Diabetic Hypertensive Patients with Coronary Atherosclerosis. Cell Mol Biol (Noisy-le-grand). 2022 May 22;68(1):109-116. doi: 10.14715/cmb/2022.68.1.14.

  • Rac ME, Safranow K, Garanty-Bogacka B, Dziedziejko V, Kurzawski G, Goschorska M, Kuligowska A, Pauli N, Chlubek D. CD36 gene polymorphism and plasma sCD36 as the risk factor in higher cholesterolemia. Arch Pediatr. 2018 Apr;25(3):177-181. doi: 10.1016/j.arcped.2018.01.008. Epub 2018 Mar 23.

  • Blomquist C, Chorell E, Ryberg M, Mellberg C, Worrsjo E, Makoveichuk E, Larsson C, Lindahl B, Olivecrona G, Olsson T. Decreased lipogenesis-promoting factors in adipose tissue in postmenopausal women with overweight on a Paleolithic-type diet. Eur J Nutr. 2018 Dec;57(8):2877-2886. doi: 10.1007/s00394-017-1558-0. Epub 2017 Oct 26.

  • do Amaral CL, Milagro FI, Curi R, Martinez JA. DNA methylation pattern in overweight women under an energy-restricted diet supplemented with fish oil. Biomed Res Int. 2014;2014:675021. doi: 10.1155/2014/675021. Epub 2014 Jan 22.

  • Mora-Rodriguez R, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M. Weight loss but not gains in cardiorespiratory fitness after exercise-training predicts improved health risk factors in metabolic syndrome. Nutr Metab Cardiovasc Dis. 2018 Dec;28(12):1267-1274. doi: 10.1016/j.numecd.2018.08.004. Epub 2018 Aug 23.

  • Alkhatatbeh MJ, Ayoub NM, Mhaidat NM, Saadeh NA, Lincz LF. Soluble cluster of differentiation 36 concentrations are not associated with cardiovascular risk factors in middle-aged subjects. Biomed Rep. 2016 May;4(5):642-648. doi: 10.3892/br.2016.622. Epub 2016 Mar 3.

  • Yanai H, Chiba H, Morimoto M, Jamieson GA, Matsuno K. Type I CD36 deficiency in humans is not associated with insulin resistance syndrome. Thromb Haemost. 2000 May;83(5):786. No abstract available.

  • Furuhashi M, Ura N, Nakata T, Shimamoto K. Insulin sensitivity and lipid metabolism in human CD36 deficiency. Diabetes Care. 2003 Feb;26(2):471-4. doi: 10.2337/diacare.26.2.471.

  • Lopez-Carmona MD, Plaza-Seron MC, Vargas-Candela A, Tinahones FJ, Gomez-Huelgas R, Bernal-Lopez MR. CD36 overexpression: a possible etiopathogenic mechanism of atherosclerosis in patients with prediabetes and diabetes. Diabetol Metab Syndr. 2017 Jul 18;9:55. doi: 10.1186/s13098-017-0253-x. eCollection 2017.

  • Griffin E, Re A, Hamel N, Fu C, Bush H, McCaffrey T, Asch AS. A link between diabetes and atherosclerosis: Glucose regulates expression of CD36 at the level of translation. Nat Med. 2001 Jul;7(7):840-6. doi: 10.1038/89969.

  • Marechal L, Laviolette M, Rodrigue-Way A, Sow B, Brochu M, Caron V, Tremblay A. The CD36-PPARgamma Pathway in Metabolic Disorders. Int J Mol Sci. 2018 May 21;19(5):1529. doi: 10.3390/ijms19051529.

  • Pardina E, Ferrer R, Rossell J, Ricart-Jane D, Mendez-Lara KA, Baena-Fustegueras JA, Lecube A, Julve J, Peinado-Onsurbe J. Hepatic CD36 downregulation parallels steatosis improvement in morbidly obese undergoing bariatric surgery. Int J Obes (Lond). 2017 Sep;41(9):1388-1393. doi: 10.1038/ijo.2017.115. Epub 2017 May 10.

  • Botha J, Nielsen MH, Christensen MH, Vestergaard H, Handberg A. Bariatric surgery reduces CD36-bearing microvesicles of endothelial and monocyte origin. Nutr Metab (Lond). 2018 Oct 23;15:76. doi: 10.1186/s12986-018-0309-4. eCollection 2018.

  • Knosgaard L, Kazankov K, Birkebaek NH, Holland-Fischer P, Lange A, Solvig J, Horlyck A, Kristensen K, Rittig S, Vilstrup H, Gronbaek H, Handberg A. Reduced sCD36 following weight loss corresponds to improved insulin sensitivity, dyslipidemia and liver fat in obese children. Eur J Clin Nutr. 2016 Sep;70(9):1073-7. doi: 10.1038/ejcn.2016.88. Epub 2016 Jun 8.

MeSH Terms

Conditions

Metabolic SyndromeWeight Loss

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Mehmet FISUNOGLU, Assoc. Prof.

    Hacettepe University

    STUDY DIRECTOR
  • Ozlem Ozdemir, Assist. Prof

    Ordu University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are 2 groups in the study. Both groups consist of individuals with newly diagnosed metabolic syndrome. The first group (intervention group) is the group that applied a weight loss diet and achieved weight loss. The second group (control group) is the group that did not apply a diet and did not achieve weight loss.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 18, 2025

Study Start

June 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 30, 2020

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

I do not want to share this before publishing the research as a research article.

Locations