HyperlipidaemiaNCT05233917
Effects of Olive Oil and MLCT on Glycolipid Homeostasis in Patients With Metabolic Syndrome
A study testing Olive oil use and MLCT oil use in people with Hyperlipidaemia and Metabolic Syndrome, run by Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hyperlipidaemia, Metabolic Syndrome
- What is being tested?
- Olive oil use and MLCT oil use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2023to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Olive oil use, MLCT oil use
- Keywords
- Olive oil, MLCT oil, plasma metabolome, gut microbiota
- Medical subject headings
- Hyperlipidemias, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive oil useDietary supplement
Olive oil, 25-30g/d by day for 6 month
MLCT oil useDietary supplement
MLCT oil, 25-30g/d by day for 6 month
| Study group | Role | What they receive |
|---|---|---|
| Olive oil group | Experimental | Olive oil use，25-30 g per day for six month Receives: Dietary Supplement: Olive oil use |
| MLCT oil group | Experimental | MLCT oil use，25-30 g per day for six month Receives: Dietary Supplement: MLCT oil use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight from baseline
The investigators will measure body weight of participants before and after treatment.
Measured: 6 month
Change in triglycerides from baseline
The investigators will measure triglyceride levels in blood samples before and after treatment.
Measured: 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.
Measured: 6 month
Secondary outcomes (4)
Change in waist circumference from baseline
The investigators will measure waist circumference of participants before and after treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start9 Jun 2023
- Primary completion9 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidaemiaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Zhang, Zhejiang University
- Investigators
- Yu Zhang, PhD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233917
- Sponsor's protocol ID
- RCT-Olive and MLCT
- Status last verified
- Feb 2024
- First submitted
- 29 Dec 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Precision Nutritional Management for MetS (PNMM)
- ClinicalTrials.gov ID
- NCT05233917
- Acronym / sponsor ID
- RCT-Olive and MLCT
- Conditions
- Hyperlipidaemia, Metabolic Syndrome
- Keywords
- Olive oil, MLCT oil, plasma metabolome, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 9 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olive oil group | Experimental | Dietary Supplement: Olive oil useOlive oil use，25-30 g per day for six month |
| MLCT oil group | Experimental | Dietary Supplement: MLCT oil useMLCT oil use，25-30 g per day for six month |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive oil useOlive oil, 25-30g/d by day for 6 month | Dietary supplement | Olive oil group |
| MLCT oil useMLCT oil, 25-30g/d by day for 6 month | Dietary supplement | MLCT oil group |
Primary outcome
Change in body weight from baseline
Time frame: 6 month
The investigators will measure body weight of participants before and after treatment.
Change in triglycerides from baseline
Time frame: 6 month
The investigators will measure triglyceride levels in blood samples before and after treatment.
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.
4 secondary outcomes
Change in waist circumference from baseline
Time frame: 6 month
Change in MetS indicators from baseline
Time frame: 6 month
Change in gut microbiota from baseline
Time frame: 6 month
Change in blood metabolome
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Zhang, PhD principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive oil use and MLCT oil use in people with Hyperlipidaemia and Metabolic Syndrome, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight from baseline (time frame: 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.