Effects of Olive Oil and MLCT on Glycolipid Homeostasis in Patients With Metabolic Syndrome

NCT ID: NCT05233917

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-09
• Study Completion Date: 2023-12-22

Brief Summary

The type of cooking oil used is a crucial factor influencing dietary quality. The purpose of this study is to investigate the effects of olive oil and MLCT oil intervention on glucose and lipid homeostasis in patients with MetS.

Detailed Description

We conducted a 6-month RCT to evaluate the effects of olive oil and MLCT as cooking oils on glucose and lipid homeostasis in patients with MetS; investigate the changes in lipoprotein subfractions and metabolites using NMR spectroscopy, alongside gut microbiota alterations, to elucidate potential mechanisms; and identify baseline variables associated with the anti-obesity effects of olive oil and MLCT.

Conditions

Hyperlipidaemia; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Olive oil group

Olive oil use，25-30 g per day for six month

Group Type: EXPERIMENTAL

Olive oil use

Intervention Type: DIETARY_SUPPLEMENT

Olive oil, 25-30g/d by day for 6 month

MLCT oil group

MLCT oil use，25-30 g per day for six month

Group Type: EXPERIMENTAL

MLCT oil use

Intervention Type: DIETARY_SUPPLEMENT

MLCT oil, 25-30g/d by day for 6 month

Interventions

Olive oil use

Olive oil, 25-30g/d by day for 6 month

Intervention Type: DIETARY_SUPPLEMENT

MLCT oil use

MLCT oil, 25-30g/d by day for 6 month

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Participants eligible for the study were those with a confirmed MetS diagnosis according to the IDF criteria53, aged between 40 and 70, and who reported infrequent consumption of meals outside the home (≤3 times per week)

Exclusion Criteria

(i) current breastfeeding or pregnancy; (ii) history of cardiovascular disease, including heart disease, coronary artery disease, stroke, cerebral infarction, viral hepatitis (e.g., hepatitis A or B), chronic kidney disease (estimated glomerular filtration rate [GFR] <60 ml/min), or malignancy; (iii) presence of diabetic ketoacidosis or hyperketonemia; (iv) recent alterations in prescribed medication within the previous 6 months; (v) current use of insulin therapy; (vi) consumption of MLCT in the preceding 6 months; (vii) participation in other clinical research studies within the last 6 months; and (viii) premenopausal women

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Yu Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

Lanxi Hospital of Traditional Chinese Medicine

Jinhua, Zhejiang, China

Countries

China

Other Identifiers

RCT-Olive and MLCT

Identifier Type: -

Identifier Source: org_study_id