NCT06674018

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

Indole-3-PROpionic Acid Clinical Trials - a Pilot Study (iPROACT-pilot)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Glostrup University Hospital, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Indole-3-propionic acid (IPA) is a gut bacterial metabolite with the amino acid tryptophan as substrate. In vitro and animal studies, suggest that IPA could contribute to regulating inflammation and metabolic function, preventing oxidative damage and upregulating expression of brain-derived neurotrophic factor. With this study we aim to investigate the biochemical effects of IPA at supraphysiological levels in humans.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Indole-3-propionic acid	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.
DIETARY_SUPPLEMENT	Placebo	Two capsules of placebo will be taken orally, once daily in the morning after an overnight fast for 14 consecutive days.

Timeline

• Start date: 2024-11-14
• Primary completion: 2025-02-25
• Completion: 2025-02-25
• First posted: 2024-11-05
• Last updated: 2025-03-05

Locations

1 site across 1 country: Denmark