Indole-3-PROpionic Acid Clinical Trials - a Pilot Study

NCT06674018 | Completed

• 1 other identifier: H-24008127
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot intervention trial is to investigate the biological effects of daily supplementation with different doses of indole-3-propionic acid (IPA) in healthy adults. The main scientific questions are:

• Does supplementation with IPA increase the abundance regulatory T cells in the blood? Regulatory T cells are believed to play an important role in preventing autoimmune diseases.
• Does supplementation with IPA increase the concentration of brain-derived neurotrophic factor (BDNF) in the blood? BDNF is believed to play an important role in maintaining brain health.
• Does supplementation with IPA affect blood analyses commonly performed to assess the risk of metabolic disorders like type 2 diabetes and cardiovascular diseases?
• How big a dose of IPA is necessary to achieve the above benefits? Participants will:
• Take 50 mg IPA or 120 mg IPA or 500 mg IPA or placebo every morning for 14 days.
• Visit the clinic at the beginning (day 1) and at the end (day 15) of IPA supplementation to deliver blood, urine and fecal samples, have simple measurements performed, fulfil questionnaires and report any side effects.

Conditions

Healthy

Keywords

Indole-3-propionic acid; gut bacterial metabolite; regulatory T cells; brain-derived neurotrophic factor; dietary supplement

Outcome Measures

Primary Outcomes (2)

• Regulatory T cells (first primary outcome)

  FoxP3+CD25+CD127- regulatory T cells expressed as a percentage of single, live CD3+CD4+CD8- lymphocytes. Analysed in freshly isolated peripheral blood mononuclear cells using a Symphony A3 flowcytometer.

  Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).

• Brain-derived neurotrophic factor (second primary outcome)

  Brain-derived neurotrophic factor measured in plasma samples using ELISA or mesoscale.

  Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).

Secondary Outcomes (27)

• Flowcytometric profiling of T cells

  Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).

• CRP

  Results from blood samples taken on day 15 (just before last supplement/placebo dosis) and adjusted for results from day 1 (just before first supplement/placebo dosis).

• Triglycerides

  Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).

• non-HDL cholesterol

  Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).

• C-peptide

  Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).

Other Outcomes (20)

• Gastrointestinal comfort

  Gastrointestinal symptoms are assessed on day 1 and day 15.

• Gastrointestinal transit time

  Maize is ingested five days before visit 1 and again five days before visit 2.

• Stool consistency

  Bristol stool chart is used in association with each maize test and collection of fecal samples (earliest 48 hours prior to first visit and day 3 or soonest thereafter and again earliest 48 hours prior to last visit (day 15)).

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

50 mg IPA

EXPERIMENTAL

50 mg indole-3-propionic acid

Dietary Supplement: Indole-3-propionic acid

120 mg IPA

EXPERIMENTAL

120 mg indole-3-propionic acid

Dietary Supplement: Indole-3-propionic acid

500 mg IPA

EXPERIMENTAL

500 mg indole-3-propionic acid

Dietary Supplement: Indole-3-propionic acid

Interventions

Indole-3-propionic acid DIETARY_SUPPLEMENT

A dosis of either 50 mg IPA, 120 mg IPA or 500 mg IPA (two capsules) will be taken orally, once daily in the morning after an overnight fast for 14 consecutive days.

120 mg IPA; 50 mg IPA; 500 mg IPA

Placebo DIETARY_SUPPLEMENT

Two capsules of placebo will be taken orally, once daily in the morning after an overnight fast for 14 consecutive days.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy women and men ≥18 and ≤65 years of age
• Deemed mentally and physically able to participate

You may not qualify if:

• Diagnosis of gut-, heart-, liver-, kidney or immune-related disorders
• Use of antibiotics within the last month
• Pregnant or lactating women or birth within the last five months
• Use of medicine that requires prescription

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead
• University of Copenhagen: collaborator
• University of Southampton: collaborator

Study Sites (1)

Optic Neuritis Clinic, Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet-Glostrup

Glostrup Municipality, 2600, Denmark

Location

Study Officials

• Jette Lautrup Frederiksen, Prof, DMSc, MD

  Jette Lautrup Frederiksen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization is performed by external party. Each capsule bottle is named with a unique number (1-96) and no other identifier. Capsule bottles have already been randomized by the external party using block randomization with random block sizes of 4 or 8. Study participants receive the next available capsule bottle based on their order of recruitment. This way, everyone involved in the study is fully blinded and it is also impossible to guess which participants belong to the same group. Only after all study participants have been recruited and the collected data have been cleaned and quality checked, are the researchers performing the statistical analyses informed about which participants belong to the same group as well as the identity of the groups. This is a prerequisite for performance of statistical analyses, as the primary analysis is defined as the comparison between the group with the highest treatment dose and placebo.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Clinical Consultant, DMSc, MD

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 5, 2024
• Study Start: November 14, 2024
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following publication of the article they are presented in.
• Access Criteria: Researchers who provide a methodologically sound proposal can access the IPD to achieve the aims of the approved proposal. Proposals should be directed to jette.lautrup.battistini@regionh.dk. To gain access, data requestors will need to sign a data access agreement. Data and explanatory files will be made available at a third party website.

Locations

DK (1)