NCT07183488

Brief Summary

The primary objective of this study is to investigate the acute physiological and metabolic effects of ingesting the short-chain fatty acids (SCFA)s propionate (three carbon atoms long; C3:0) and butyrate (C4:0) in healthy men and women. This aim will be addressed through a block-randomized cross-over study including two visits with acute intake of propionate and butyrate, respectively. The hypothesis is that plasma ketone body levels will increase during the first three hours after intake of butyrate, but not propionate, in healthy individuals in the overnight fasted state.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
53mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress13%
Sep 2025Sep 2030

First Submitted

Initial submission to the registry

August 27, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

September 10, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Expected
Last Updated

March 10, 2026

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

August 27, 2025

Last Update Submit

March 9, 2026

Conditions

HealhtyOther: Short-Chain Fatty Acid (SCFA)Other: Butyrate (C4)Other: Propionate (C3)

Outcome Measures

Primary Outcomes (1)

  • Ketone Bodies

    To measure the effect of Short-Chain Fatty Acid Butyrate (SCFA-BUT) and Short-Chain Fatty Acid Propionate (SCFA-PRO) on circulating ketone body concentrations.

    On day 1 (test day 1) and day 2 (test day 2) at baseline (-30 min and 0 min) and post intake (10 min, 15 min, 22.5 min, 30 min, 45 min, 60 min, 90 min, 120 min, and 180 min).

Secondary Outcomes (10)

  • Glucose

    On day 1 (test day 1) and day 2 (test day 2) at baseline (-30 min and 0 min) and post intake (10 min, 15 min, 22.5 min, 30 min, 45 min, 60 min, 90 min, 120 min, and 180 min).

  • Fatty acids

    On day 1 (test day 1) and day 2 (test day 2) at baseline (-30 min and 0 min) and post intake (10 min, 15 min, 22.5 min, 30 min, 45 min, 60 min, 90 min, 120 min, and 180 min).

  • Flow mediated dilation measurement

    On day 1 (test day 1) and day 2 (test day 2) at baseline (min -15) and post intake (min 90).

  • Resting metabolic rate

    On day 1 (test day 1) and day 2 (test day 2) at baseline (min -15) and post intake (30 min, 60 min, 120 min)

  • Respiratory exchange ratio

    On day 1 (test day 1) and day 2 (test day 2) at baseline (min -15) and post intake (30 min, 60 min, 120 min)

  • +5 more secondary outcomes

Study Arms (2)

Female

EXPERIMENTAL
Other: Propionate followed by ButyrateOther: Butyrate followed by Propionate

Male

EXPERIMENTAL
Other: Propionate followed by ButyrateOther: Butyrate followed by Propionate

Interventions

Propionate followed by ButyrateOTHER

The participants will consume Short-chain fatty acid propionate (SCFA-PRO) followed by Short-Chain Fatty Acid Butyrate (SCFA-BUT).

Male
Butyrate followed by PropionateOTHER

• The participants will consume Short-chain fatty acid Butyrate (SCFA-BUT) followed by Short-Chain Fatty Acid Propionate (SCFA-PRO).

Male

Eligibility Criteria

Age18 Years - 40 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female.
  • Age between 18-40 years old
  • BMI between 18.5-29

You may not qualify if:

  • Diabetes
  • Kidney- or liver disease
  • Pregnant, lactating or planning to become pregnant within the study period
  • Supplementation with SCFAs
  • Supplementation with B12 vitamin
  • Special dietary habits (e.g. vegan/ketogenic diet)
  • Ongoing cancer treatment
  • Metabolic or absorptive disorders, gastric bypass operation, or use of medication affecting metabolism or food absorption
  • Crohn's disease, ulcerative colitis or short bowel syndrome
  • Inability, physically or mentally, to comply with the procedure required by the study protocol as evaluated by the primary investigator, study manager or clinical responsible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, Copenhagen N, 2200, Denmark

RECRUITING

Central Study Contacts

Amalie S Frederiksen, PhD student

CONTACT

+4528899561amalie.sfrederiksen@sund.ku.dk

Andreas M Fritzen, Associate Professor

CONTACT

amfritzen@sund.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 19, 2025

Study Start

September 10, 2025

Primary Completion

February 20, 2026

Study Completion (Estimated)

September 1, 2030

Last Updated

March 10, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)