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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06210230
• Other study ID #: RCT_MLCT_MetS
• Status: Completed
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: December 10, 2023

Study information

• Verified date: May 2023
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 10, 2023
• Est. primary completion date: November 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• MLCT supplementation
MLCT 25g/d for 6 months
• Olive oil
Matching placebo (olive oil) 25g/d for 6 months

Locations

Country	Name	City	State
China	Lanxi Traditional Chinese Medicine Hospital	Jinhua	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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