NCT06289296

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

February 25, 2024

Last Update Submit

February 25, 2024

Conditions

Keywords

medium-chain fatty acidsketonesObesity

Outcome Measures

Primary Outcomes (1)

  • Ketone bodies in plasma

    an increase in plasma ketone bodies induced by intake of medium-chain fatty acids in lean and obese participants

    Day 0 to day 7

Study Arms (2)

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.

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.

Other: Fatty acid intake in lean and obese males

Interventions

Acute and chronic intake of MCT and LCT

Fatty acid intake in lean malesFatty acid intake in obese males

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

KetosisObesity

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bente Kiens, D.sci, PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 25, 2024

First Posted

March 1, 2024

Study Start

January 1, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations