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

NCT05233917 | Completed

• 1 other identifier: RCT-Olive and MLCT
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidaemia; Metabolic Syndrome

Keywords

Olive oil; MLCT oil; plasma metabolome; gut microbiota

Outcome Measures

Primary Outcomes (3)

• Change in body weight from baseline

  The investigators will measure body weight of participants before and after treatment.

  6 month

• Change in triglycerides from baseline

  The investigators will measure triglyceride levels in blood samples before and after treatment.

  6 month

• Change in Body fat distribution and muscle conten from baseline

  The whole body of the patient was scanned and analyzed by a DXA (Prodigy Primo, Dalex-Ohmeda, Inc., USA) to measure the total and regional body fat mass (FM) and lean mass.

  6 month

Secondary Outcomes (4)

• Change in waist circumference from baseline

  6 month

• Change in MetS indicators from baseline

  6 month

• Change in gut microbiota from baseline

  6 month

• Change in blood metabolome

  6 month

Study Arms (2)

Olive oil group

EXPERIMENTAL

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

Dietary Supplement: Olive oil use

MLCT oil group

EXPERIMENTAL

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

Dietary Supplement: MLCT oil use

Interventions

Olive oil use DIETARY_SUPPLEMENT

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

Olive oil group

MLCT oil use DIETARY_SUPPLEMENT

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

MLCT oil group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• (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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Lanxi Hospital of Traditional Chinese Medicine

Jinhua, Zhejiang, China

Location

MeSH Terms

Conditions

Hyperlipidemias; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Yu Zhang, PhD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: February 10, 2022
• Study Start: June 9, 2023
• Primary Completion: December 9, 2023
• Study Completion: December 22, 2023
• Last Updated: November 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)