Diet, HealthyMCFANCT06289296
Medium Chain Fatty Acids and Ketones
A study testing Fatty acid intake in lean and obese males in people with Diet, Healthy and Health, run by University of Copenhagen at 1 site in Denmark.
Trial summary
16 participants were randomized to complete two seven-day intervention periods with twice-daily consumption of Medium-chain fatty acids (MCT) or long-chain fatty acids (LCT) oil. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Health
- What is being tested?
- Fatty acid intake in lean and obese males
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2022to 30 Sep 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 20 and 35
- Moderate physical activity level, defined as 1 to 3 weekly sessions of exercise.
- Non-smokers
- No use of medicine
- No known prediabetes or diabetes
Who cannot join
- High habitual intake of MCFA (e.g., coconut milk, coconut oil, or dairy products), A ketogenic diet, known diabetes or pre-diabetes, use of medications, daily use of nicotine products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Effects of Dietary Medium-Chain Fatty Acids.
16 participants were randomized to complete two seven-day intervention periods with twice-daily consumption of Medium-chain fatty acids (MCT) or long-chain fatty acids (LCT) oil. Before and after each intervention, participants completed a five-hour experimental day evaluating the response to a first intake of the MCT or LCT oils (pre MCT or LCT), which was repeated after the intervention period of daily intake (post MCT or LCT) (Fig. The intervention periods were separated by a 2-4-week washout period.
Read the detailed description
Prior to the experimental days, the participants abstained from alcohol and vigorous physical activity and consumed a controlled, eucaloric diet comprising 30 energy % (E%) fat, 52 E% carbohydrate, and 18E% protein to ensure similar conditions before each experimental day.
On the experimental days, participants arrived by passive transport in the overnight fasted state (12 h) at 8 a.m at the institute. At arrival, participants were weighed, and body composition was determined using dual-energy x-ray absorptiometry (DXA). Then a catheter was inserted into an antecubital vein. Following 30 min of supine rest, whole-body oxygen uptake and substrate oxidation were determined, whereafter a basal venous blood sample was obtained. Subsequently, participants ingested a test drink containing 35g of MCT or LCT oil diluted in 100g of a low-fat, low-carbohydrate cocoa milk within five min. 100 ml water was provided together with the test drink. Participants were blinded to the type of oil intake on the experimental days. The participants were then followed for five hours. Venous blood samples and indirect calorimetry measurements were performed frequently during the five hours. Participants rested in a bed throughout the test day.
Following the first test day, a seven-day intervention period (chronic intake) with twice-daily consumption of MCT or LCT oil was conducted. During the seven days of daily oil intake, the participants ingested 2x10g oil in 15g cocoa milk on day 1-2, 2x20g oil in 30g cocoa milk on day 3-5, and 2x30g oil in 40g cocoa milk on day 6-7. This corresponded to 812kJ on day 1-2, 1625kJ on day 3-5, and 2413kJ on day 6-7. The participants were instructed to maintain their habitual dietary patterns and physical activity level during the intervention. The participants were instructed to consume the oil together with breakfast and dinner and were supervised to ensure compliance.
After the chronic intake period, a second experimental day (post), mirroring the one of the pre day, was conducted.
After a wash-out period the intervention was repeated in a cross-over design.
- Conditions
- Diet, Healthy, Health
- Being tested
- Fatty acid intake in lean and obese males
- Keywords
- medium-chain fatty acids, ketones, Obesity
- Medical subject headings
- Ketosis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatty acid intake in lean and obese malesOther
Acute and chronic intake of MCT and LCT
| Study group | Role | What they receive |
|---|---|---|
| Fatty acid intake in lean males | Experimental | Lean males will be studied before and after 7 days daily intake of either Medium-chain fatty acids or Long-chain fatty acids. . After a wash-out period the intervention is repeated in opposite sequence. Receives: Other: Fatty acid intake in lean and obese males |
| Fatty acid intake in obese males | Experimental | In obese male participants will be studied before and after 7 days daily intake of either medium-chain fatty acids (MCT) or long-chain fatty acids (LCT). After a wash-out period the intervention is repeated in opposite sequence. Receives: Other: Fatty acid intake in lean and obese males |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ketone bodies in plasma
an increase in plasma ketone bodies induced by intake of medium-chain fatty acids in lean and obese participants
Measured: Day 0 to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Jan 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A parallel crossover design, in which a group of lean and a group of obese participants are allocated to complete two seven-day intervention periods with twice daily consumption of either medium-chain fatty acids or long-chain fatty acids.
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT06289296
- Sponsor's protocol ID
- MCT
- Acronym
- MCFA
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2024
- Last updated
- 1 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Dietary Medium-Chain Fatty Acids.
- ClinicalTrials.gov ID
- NCT06289296
- Acronym / sponsor ID
- MCFA / MCT
- Conditions
- Diet, Healthy, Health
- Keywords
- medium-chain fatty acids, ketones, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 Mar 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.
16 participants were randomized to complete two seven-day intervention periods with twice-daily consumption of Medium-chain fatty acids (MCT) or long-chain fatty acids (LCT) oil. Before and after each intervention, participants completed a five-hour experimental day evaluating the response to a first intake of the MCT or LCT oils (pre MCT or LCT), which was repeated after the intervention period of daily intake (post MCT or LCT) (Fig. The intervention periods were separated by a 2-4-week washout period.
Detailed description
Prior to the experimental days, the participants abstained from alcohol and vigorous physical activity and consumed a controlled, eucaloric diet comprising 30 energy % (E%) fat, 52 E% carbohydrate, and 18E% protein to ensure similar conditions before each experimental day.
On the experimental days, participants arrived by passive transport in the overnight fasted state (12 h) at 8 a.m at the institute. At arrival, participants were weighed, and body composition was determined using dual-energy x-ray absorptiometry (DXA). Then a catheter was inserted into an antecubital vein. Following 30 min of supine rest, whole-body oxygen uptake and substrate oxidation were determined, whereafter a basal venous blood sample was obtained. Subsequently, participants ingested a test drink containing 35g of MCT or LCT oil diluted in 100g of a low-fat, low-carbohydrate cocoa milk within five min. 100 ml water was provided together with the test drink. Participants were blinded to the type of oil intake on the experimental days. The participants were then followed for five hours. Venous blood samples and indirect calorimetry measurements were performed frequently during the five hours. Participants rested in a bed throughout the test day.
Following the first test day, a seven-day intervention period (chronic intake) with twice-daily consumption of MCT or LCT oil was conducted. During the seven days of daily oil intake, the participants ingested 2x10g oil in 15g cocoa milk on day 1-2, 2x20g oil in 30g cocoa milk on day 3-5, and 2x30g oil in 40g cocoa milk on day 6-7. This corresponded to 812kJ on day 1-2, 1625kJ on day 3-5, and 2413kJ on day 6-7. The participants were instructed to maintain their habitual dietary patterns and physical activity level during the intervention. The participants were instructed to consume the oil together with breakfast and dinner and were supervised to ensure compliance.
After the chronic intake period, a second experimental day (post), mirroring the one of the pre day, was conducted.
After a wash-out period the intervention was repeated in a cross-over design.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A parallel crossover design, in which a group of lean and a group of obese participants are allocated to complete two seven-day intervention periods with twice daily consumption of either medium-chain fatty acids or long-chain fatty acids.
| Arm | Type | Receives |
|---|---|---|
| Fatty acid intake in lean males | Experimental | Other: Fatty acid intake in lean and obese malesLean males will be studied before and after 7 days daily intake of either Medium-chain fatty acids or Long-chain fatty acids. . After a wash-out period the intervention is repeated in opposite sequence. |
| Fatty acid intake in obese males | Experimental | Other: Fatty acid intake in lean and obese malesIn obese male participants will be studied before and after 7 days daily intake of either medium-chain fatty acids (MCT) or long-chain fatty acids (LCT). After a wash-out period the intervention is repeated in opposite sequence. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI between 20 and 35
- Moderate physical activity level, defined as 1 to 3 weekly sessions of exercise.
- Non-smokers
- No use of medicine
- No known prediabetes or diabetes
Key exclusion criteria (1 listed)
- High habitual intake of MCFA (e.g., coconut milk, coconut oil, or dairy products), A ketogenic diet, known diabetes or pre-diabetes, use of medications, daily use of nicotine 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 |
|---|---|---|
| Fatty acid intake in lean and obese malesAcute and chronic intake of MCT and LCT | Other | Fatty acid intake in lean males, Fatty acid intake in obese males |
Primary outcome
Ketone bodies in plasma
Time frame: Day 0 to day 7
an increase in plasma ketone bodies induced by intake of medium-chain fatty acids in lean and obese participants
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 1 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.
Bente Kiens, D.sci, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatty acid intake in lean and obese males in people with Diet, Healthy and Health, run by University of Copenhagen at 1 site 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 5 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 1 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 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?
Ketone bodies in plasma (time frame: Day 0 to day 7). 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 1 Mar 2024.