Comparison of Cardiometabolic Markers in Individuals With Hypertriglyceridemia With Low and High Weight Loss Responses to an Energy-restricted Diet

NCT07012226 | Completed

• 1 other identifier: 43014022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Total RNA is extracted from isolated white blood cells, and cDNA is synthesized from these samples. Subsequently, the expression levels of the SIRT1 and leptin receptor genes are determined through quantitative PCR.

Conditions

Hypertriglyceridaemia; Obesity and Overweight

Outcome Measures

Primary Outcomes (2)

• Gene expression of SIRT1

  Expression levels of SIRT1 gene in white blood cells

  up to 2 months

• Plasma lipid profile

  The plasma concentrations of triglycerides, cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol

  up to 2 months

Secondary Outcomes (3)

• Plasma adipokines

  up to 2 months

• Gene expression of leptin receptor

  up to 2 months

• Plasma inflammatory markers

  up to 2 months

Study Arms (1)

Low-calorie diet

OTHER

Low-calorie diet

Other: Low-calorie diet

Interventions

Low-calorie diet OTHER

Low-calorie diet based on calculated calorie needs

Low-calorie diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate hypertriglyceridemia (TG=150-500 mg/dL)
• Body mass index (BMI) greater than 25
• Not using fibrates

You may not qualify if:

• Advanced chronic kidney disease patients
• Patients with liver cirrhosis
• Unwillingness to continue cooperating with the study
• Any change in the treatment plan during the study, including changes in the type and dose of medications taken or the start of medications that affect blood lipids

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Nutrition Clinic located in the Faculty of Nutrition Sciences, Shahid Beheshti University of Medical Sciences

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Obesity; Overweight; Hypertriglyceridemia

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 10, 2025
• Study Start: June 10, 2025
• Primary Completion: January 12, 2026
• Study Completion: January 27, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)