- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06289296
Medium Chain Fatty Acids and Ketones (MCFA)
Metabolic Effects of Dietary Medium-Chain Fatty Acids.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- University of Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fatty acid intake in lean males
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.
|
Acute and chronic intake of MCT and LCT
|
Experimental: Fatty acid intake in obese males
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.
|
Acute and chronic intake of MCT and LCT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 0 to day 7
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bente Kiens, D.sci, PhD, University of Copenhagen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MCT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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