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

NCT ID: NCT06210230

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2023-12-10

Brief Summary

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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

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

Group Type PLACEBO_COMPARATOR

Olive oil

Intervention Type DIETARY_SUPPLEMENT

Matching placebo (olive oil) 25g/d for 6 months

Intervention group

Group Type EXPERIMENTAL

MLCT supplementation

Intervention Type DIETARY_SUPPLEMENT

MLCT 25g/d for 6 months

Interventions

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MLCT supplementation

MLCT 25g/d for 6 months

Intervention Type DIETARY_SUPPLEMENT

Olive oil

Matching placebo (olive oil) 25g/d for 6 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Yu Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lanxi Traditional Chinese Medicine Hospital

Jinhua, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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RCT_MLCT_MetS

Identifier Type: -

Identifier Source: org_study_id

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