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NCT Number: NCT05233917

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

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lanxi Hospital of Traditional Chinese Medicine

Jinhua, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olive oil use

Dietary Supplement

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

MLCT oil use

Dietary Supplement

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

Primary outcomes

  1. Change in body weight from baseline

    Time frame: 6 month

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

  2. Change in triglycerides from baseline

    Time frame: 6 month

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

  3. Change in Body fat distribution and muscle conten from baseline

    Time frame: 6 month

    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.

Secondary outcomes

  1. Change in waist circumference from baseline

    Time frame: 6 month

    The investigators will measure waist circumference of participants before and after treatment.

  2. Change in MetS indicators from baseline

    Time frame: 6 month

    The investigators will measure TC, LDL-C, HDL-C, and glucose levels in blood samples and blood pressure before and after treatment.

  3. Change in gut microbiota from baseline

    Time frame: 6 month

    The investigators will collect faeces sample from every participants and 16S rDNA sequencing will be used to analyze the composition of gut microbiota.

  4. Change in blood metabolome

    Time frame: 6 month

    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.

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

The Precision Nutritional Management for MetS (PNMM)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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