Healthy NutritionLipidomixNCT06368271
Acute Effects of Dietary Medium-chain Fatty Acids on Lipid Profile
A study testing Lipidomics in people with Healthy Nutrition and Diet, Healthy, run by University of Copenhagen at 2 sites in Denmark.
Trial summary
In the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (MCT) and long chain fatty acids (LCT),, respectively. In addition oxygen uptake was measured to study energy turnover. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition, Diet, Healthy
- What is being tested?
- Lipidomics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Oct 2021to 28 Feb 2024
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males BMI:20-27 recreationally physical active non-smoker no medicine
- -
Who cannot join
- high habitual intake of MCT-rich foods as coconut, coconut oil and dairy products
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
University of Copenhagen
Copenhagen, 2100
Department of Nutrition, Exercise and Sports
Copenhagen
About this study
Official title: Acute Effects of Dietary Medium-chain Fatty Acids on Llipid Profile
In the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (MCT) and long chain fatty acids (LCT),, respectively. In addition oxygen uptake was measured to study energy turnover.
Read the detailed description
Four participants ingested MCT or LCT oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consumed a eucaloric control diet, and abstained from alcohol and vigorous physical activity to ensure similar conditions on experimental days.
On the test days, participants arrived by passive transport in the overnight fasted state (12 h) at 8 a.m., and a catheter was inserted into an antecubital vein. Following 30 min in supine rest, an overnight-fasted, basal venous blood sample was obtained. Subsequently, participants ingested the same test drink as in study 1 (containing 35g of MCT or LCT oil diluted in 100g of low-fat, low-carbohydrate cocoa milk) within five min. 100 ml water was provided together with the test drink. Venous blood samples were drawn every 30 min for the first two hours and every 60 minutes for the last two hours following intake. Participants rested in a bed throughout the test day. this This process was repeated on the second test day.
- Conditions
- Healthy Nutrition, Diet, Healthy
- Being tested
- Lipidomics
- Keywords
- medium-chain fatty acids, lipidomics, acute intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipidomicsDietary supplement
Health beneficial effects of medium-chain fatty acids
| Study group | Role | What they receive |
|---|---|---|
| Intake of fatty acids | Experimental | ,Participants ingest a test drink containing 35g of MCT or LCT oil diluted in 100g of low-fat, low-carb cocoa milk) within five min. Blood and oxygen uptake are obtained frequently during the following 4 hours. Receives: Dietary Supplement: Lipidomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meal test including medium-chain fatty acids
In this study the effect of an acute intake of MCT oil compared with the intake of LCT (containing 35g of MCT or LCT oil diluted in 100g of low-fat, low-carb cocoa milk ) on the plasma lipid profile is studied in healthy men. Blood is obtained postprandially ( frequently during 4 hours) and analyzed for the plasma lipid profile
Measured: 0-4 hours
Secondary outcomes (1)
Resting metabolic rate
The secondary outcome of this study is to investigate the effect of an acute intake of MCT or LCT oil (35g of MCT or LCT) on resting metabolic rate in healthy lean men
Measured: 0-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Oct 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a randomized, double-blinded crossover design. Participants ingest Medium-chain-fatty acids (MCT) or Long-chain fatty acids (LCT) oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consume a eucaloric control diet, and abstain from alcohol and vigorous physical activity to ensure similar conditions on experimental days.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bente Kiens, University of Copenhagen
- Investigators
- Bente Kiens, D.sci, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368271
- Sponsor's protocol ID
- Lipidomix
- Acronym
- Lipidomix
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 16 Apr 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Dietary Medium-chain Fatty Acids on Llipid Profile
- ClinicalTrials.gov ID
- NCT06368271
- Acronym / sponsor ID
- Lipidomix / Lipidomix
- Conditions
- Healthy Nutrition, Diet, Healthy
- Keywords
- medium-chain fatty acids, lipidomics, acute intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 16 Apr 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.
In the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (MCT) and long chain fatty acids (LCT),, respectively. In addition oxygen uptake was measured to study energy turnover.
Detailed description
Four participants ingested MCT or LCT oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consumed a eucaloric control diet, and abstained from alcohol and vigorous physical activity to ensure similar conditions on experimental days.
On the test days, participants arrived by passive transport in the overnight fasted state (12 h) at 8 a.m., and a catheter was inserted into an antecubital vein. Following 30 min in supine rest, an overnight-fasted, basal venous blood sample was obtained. Subsequently, participants ingested the same test drink as in study 1 (containing 35g of MCT or LCT oil diluted in 100g of low-fat, low-carbohydrate cocoa milk) within five min. 100 ml water was provided together with the test drink. Venous blood samples were drawn every 30 min for the first two hours and every 60 minutes for the last two hours following intake. Participants rested in a bed throughout the test day. this This process was repeated on the second test day.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a randomized, double-blinded crossover design. Participants ingest Medium-chain-fatty acids (MCT) or Long-chain fatty acids (LCT) oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consume a eucaloric control diet, and abstain from alcohol and vigorous physical activity to ensure similar conditions on experimental days.
| Arm | Type | Receives |
|---|---|---|
| Intake of fatty acids | Experimental | Dietary Supplement: Lipidomics,Participants ingest a test drink containing 35g of MCT or LCT oil diluted in 100g of low-fat, low-carb cocoa milk) within five min. Blood and oxygen uptake are obtained frequently during the following 4 hours. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy males BMI:20-27 recreationally physical active non-smoker no medicine
- -
Key exclusion criteria (1 listed)
- high habitual intake of MCT-rich foods as coconut, coconut oil and dairy products
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 |
|---|---|---|
| LipidomicsHealth beneficial effects of medium-chain fatty acids | Dietary supplement | Intake of fatty acids |
Primary outcome
Meal test including medium-chain fatty acids
Time frame: 0-4 hours
In this study the effect of an acute intake of MCT oil compared with the intake of LCT (containing 35g of MCT or LCT oil diluted in 100g of low-fat, low-carb cocoa milk ) on the plasma lipid profile is studied in healthy men. Blood is obtained postprandially ( frequently during 4 hours) and analyzed for the plasma lipid profile
1 secondary outcome
Resting metabolic rate
Time frame: 0-4 hours
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 16 Apr 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.
Bente Kiens, D.sci, PhD principal investigator
University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipidomics in people with Healthy Nutrition and Diet, Healthy, run by University of Copenhagen at 2 sites in Denmark.
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 2 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 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Meal test including medium-chain fatty acids (time frame: 0-4 hours). 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 16 Apr 2024.