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

The Precision Nutritional Management for MetS (PNMM)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05233917
Enrollment
240
Registered
2022-02-10
Start date
2023-06-09
Completion date
2023-12-22
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidaemia, Metabolic Syndrome

Keywords

Olive oil, MLCT oil, plasma metabolome, gut microbiota

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.

Interventions

DIETARY_SUPPLEMENTOlive oil use

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

DIETARY_SUPPLEMENTMLCT oil use

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

Sponsors

Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Body fat distribution and muscle conten from baseline6 monthThe 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.
Change in body weight from baseline6 monthThe investigators will measure body weight of participants before and after treatment.
Change in triglycerides from baseline6 monthThe investigators will measure triglyceride levels in blood samples before and after treatment.

Secondary

MeasureTime frameDescription
Change in waist circumference from baseline6 monthThe investigators will measure waist circumference of participants before and after treatment.
Change in blood metabolome6 monthThe investigators will collect blood samples from every participant and the high-throughput NMR metabolomics platform will be used to analyze the blood metabolomics profile.
Change in MetS indicators from baseline6 monthThe investigators will measure TC, LDL-C, HDL-C, and glucose levels in blood samples and blood pressure before and after treatment.
Change in gut microbiota from baseline6 monthThe investigators will collect faeces sample from every participants and 16S rDNA sequencing will be used to analyze the composition of gut microbiota.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026