Medium Chain Fatty Acids and Ketones (MCFA)

February 25, 2024 updated by: Bente Kiens, University of Copenhagen

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, 2100
        • University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bente Kiens, D.sci, PhD, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

February 25, 2024

First Submitted That Met QC Criteria

February 25, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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