Double-blind and Placebo-controlled Study on Intervention Effect of Medium and Long Chain Fatty Acid Triglyceride on Glycolipid Homeostasis in Patients With Metabolic Syndrome and Mechanisms

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: MLCT supplementation; Dietary Supplement: Olive oil

• Registration Number: NCT06210230
• Lead Sponsor: Zhejiang University

Brief Summary

Double-blind and placebo-controlled study on intervention effect of medium and long chain fatty acid triglyceride on glycolipid homeostasis in patients with metabolic syndrome and mechanisms

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-22
• Primary Completion: 2023-11-22
• Study Completion: 2023-12-10
• Study First Submitted: 2024-01-06
• Study First Submitted QC: 2024-01-06
• Study First Posted: 2024-01-18
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Diagnosed metabolic syndrome according to IDF diagnostic criteria;
• Rarely eating out of home;
• Aged between 40 and 70 years.

Exclusion Criteria

• Breastfeeding or pregnancy;
• History of heart disease, coronary heart disease, stroke, cerebral infarction, viral liver disease (hepatitis A, hepatitis B, etc.), chronic kidney disease (GFR<60 ml/min) or cancer;
• Diabetic ketoacidosis or hyperketosis;
• Drug use has changed in the past six months;
• Taking insulin;
• Used MLCT edible oil in the past six months;
• Have participated in other clinical trials in the last three months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	MLCT supplementation	-
Control group	Olive oil	-

Primary Outcome Measures

Name	Time	Method
Change in blood lipids from baseline	6 months	The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.
Change in blood glucose from baseline	6 months	The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment.

Trial Locations

Locations (1)

Lanxi Traditional Chinese Medicine Hospital; 🇨🇳 Jinhua, Zhejiang, China