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

The Precision Nutritional Management for MetS (PNMM)

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Hyperlipidaemia
• Intervention / Treatment: Dietary supplement: Olive oil use; Dietary supplement: MLCT oil use

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Jinhua, Zhejiang, China
      • Lanxi Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Subjects are eligible residents from 10 government-administered units including 7 urban towns and 3 rural villages of Jinhua, China.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olive oil group; Olive oil use，25-30 g per day for six month	Dietary supplement: Olive oil use; Olive oil, 25-30g/d by day for 6 month
Experimental: MLCT oil group; MLCT oil use，25-30 g per day for six month	Dietary supplement: MLCT oil use; MLCT oil, 25-30g/d by day for 6 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in waist circumference from baseline	The investigators will measure waist circumference of participants before and after treatment.	6 month
Change in MetS indicators from baseline	The investigators will measure TC, LDL-C, HDL-C, and glucose levels in blood samples and blood pressure before and after treatment.	6 month
Change in gut microbiota from baseline	The investigators will collect faeces sample from every participants and 16S rDNA sequencing will be used to analyze the composition of gut microbiota.	6 month
Change in blood metabolome	The investigators will collect blood samples from every participant and the high-throughput NMR metabolomics platform will be used to analyze the blood metabolomics profile.	6 month

Collaborators and Investigators

• Sponsor: Zhejiang University
• Investigators: Principal Investigator: Yu Zhang, PhD, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Actual): December 9, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: gut microbiota; Olive oil; MLCT oil; plasma metabolome
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Dyslipidemias; Lipid Metabolism Disorders; Syndrome; Metabolic Syndrome; Hyperlipidemias
• Other Study ID Numbers: RCT-Olive and MLCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No