Metabolic SyndromeNCT06210230
Double-blind and Placebo-controlled Study on Intervention Effect of Medium and Long Chain Fatty Acid Triglyceride on Glycolipid Homeostasis in Patients With Metabolic Syndrome and Mechanisms
A study testing MLCT supplementation and Olive oil in people with Metabolic Syndrome, run by Zhejiang University at 1 site in China.
Trial summary
Double-blind and placebo-controlled study on intervention effect of medium and long chain fatty acid triglyceride on glycolipid homeostasis in patients with metabolic syndrome and mechanisms Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- MLCT supplementation and Olive oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2023to 10 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
- Diagnosed metabolic syndrome according to IDF diagnostic criteria;
- Rarely eating out of home;
- Aged between 40 and 70 years.
Who cannot join
- Breastfeeding or pregnancy;
- History of heart disease, coronary heart disease, stroke, cerebral infarction, viral liver disease (hepatitis A, hepatitis B, etc.), chronic kidney disease (GFR<60 ml/min) or cancer;
- Diabetic ketoacidosis or hyperketosis;
- Drug use has changed in the past six months;
- Taking insulin;
- Used MLCT edible oil in the past six months;
- Have participated in other clinical trials in the last three months.
Trial locations and contacts
1 site in 1 country.
China1 site
Lanxi Traditional Chinese Medicine Hospital
Jinhua, Zhejiang, 321102
About this study
Double-blind and placebo-controlled study on intervention effect of medium and long chain fatty acid triglyceride on glycolipid homeostasis in patients with metabolic syndrome and mechanisms
- Conditions
- Metabolic Syndrome
- Being tested
- MLCT supplementation, Olive oil
- Keywords
- metabolic syndrome, MLCT
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLCT supplementationDietary supplement
MLCT 25g/d for 6 months
Olive oilDietary supplement
Matching placebo (olive oil) 25g/d for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Not described Receives: Dietary Supplement: Olive oil |
| Intervention group | Experimental | Not described Receives: Dietary Supplement: MLCT supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose from baseline
The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment.
Measured: 6 months
Change in blood lipids from baseline
The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start22 May 2023
- Primary completion22 Nov 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210230
- Sponsor's protocol ID
- RCT_MLCT_MetS
- Status last verified
- May 2023
- First submitted
- 6 Jan 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind and Placebo-controlled Study on Intervention Effect of Medium and Long Chain Fatty Acid Triglyceride on Glycolipid Homeostasis in Patients With Metabolic Syndrome and Mechanisms
- ClinicalTrials.gov ID
- NCT06210230
- Acronym / sponsor ID
- RCT_MLCT_MetS
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, MLCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 18 Jan 2024 (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.
Double-blind and placebo-controlled study on intervention effect of medium and long chain fatty acid triglyceride on glycolipid homeostasis in patients with metabolic syndrome and mechanisms
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 |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: Olive oil |
| Intervention group | Experimental | Dietary Supplement: MLCT supplementation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed metabolic syndrome according to IDF diagnostic criteria;
- Rarely eating out of home;
- Aged between 40 and 70 years.
Key exclusion criteria (7 listed)
- Breastfeeding or pregnancy;
- History of heart disease, coronary heart disease, stroke, cerebral infarction, viral liver disease (hepatitis A, hepatitis B, etc.), chronic kidney disease (GFR<60 ml/min) or cancer;
- Diabetic ketoacidosis or hyperketosis;
- Drug use has changed in the past six months;
- Taking insulin;
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 |
|---|---|---|
| MLCT supplementationMLCT 25g/d for 6 months | Dietary supplement | Intervention group |
| Olive oilMatching placebo (olive oil) 25g/d for 6 months | Dietary supplement | Control group |
Primary outcome
Change in blood glucose from baseline
Time frame: 6 months
The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment.
Change in blood lipids from baseline
Time frame: 6 months
The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.
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 18 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MLCT supplementation and Olive oil in people with 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 3 inclusion and 7 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 18 Mar 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. Some participants in this study may receive a placebo. 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 blood glucose from baseline (time frame: 6 months). The study lists 2 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 18 Mar 2024.