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Completed

NCT Number: NCT06881706

Link Between Biochemical, Anthropometric Variables and CD36 in Metabolic Syndrome After a Low-calorie Diet

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.

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Key information

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordu University

Ordu, Altınordu, 52200, Turkey (Türkiye)

About this study

This research aimed to assess the impact of a weight loss diet on biochemical and anthropometric variables, as well as CD36 levels, in 80 patients newly diagnosed with metabolic syndrome (MetS) who began a weight loss program. The study was completed all of whom were diagnosed with MetS and had applied to the Internal Medicine Outpatient Clinic at Ordu University Training and Research Hospital. At the start of the study, participants were provided with medical nutrition therapy (MNT) tailored to their energy and nutritional needs, as well as their lifestyle, with the goal of achieving at least a 5% weight loss within 8 weeks. Patients were monitored regularly throughout the process.

Before initiating MNT, participants' general characteristics and dietary habits were collected through face-to-face interviews. Additionally, 24-hour dietary recalls and anthropometric measurements were taken both before and at the end of the 8th week. Biochemical data were retrieved from patient records, blood pressure was measured by a physician, and fasting blood samples were collected for CD36 analysis, which were then stored at -80°C until further examination.

By the end of the study, some individuals adhered strictly to the MNT. Statistical differences were observed in some biochemical parameters and blood pressure between those who complied with MNT and those who did not. Correlations were observed between CD36 levels and some variables.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Medical Nutrition Therapy

Other

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.

Other names: hypocaloric diet intervention, weight loss intervention

Primary outcomes

  1. Change in the intervention group

    Time frame: Week 0 - Week 8

    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.

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

Relationship Between Biochemical and Anthropometric Variables and CD36 Levels in Metabolic Syndrome Patients After Low Calorie Diet

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

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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