Two-week indole-3-propionic acid (IPA) supplementation in healthy adults
Indole-3-PROpionic Acid Clinical Trials - a Pilot Study Part 2 (iPROACT-pilot2)
This study will test whether taking indole-3-propionic acid (IPA) capsules twice daily for 14 days changes immune cell levels, the brain-support protein BDNF, or common metabolic blood markers in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Glostrup University Hospital, Copenhagen Academic / other |
| Locations | 1 site (Glostrup Municipality) |
| Trial ID | NCT07105514 on ClinicalTrials.gov |
What this trial studies
Healthy adults will take capsules to reach a total daily dose of 1,000 mg of IPA (500 mg morning, 500 mg evening) or matching placebo for 14 days. Participants visit the clinic at baseline (day 1) and at the end of supplementation (day 15) to give blood samples. Primary laboratory endpoints include the abundance of regulatory T cells, circulating brain-derived neurotrophic factor (BDNF), and standard metabolic risk blood tests. The placebo comparator and short, controlled dosing period are designed to detect short-term biochemical effects and inform larger human studies.
Who should consider this trial
Good fit: Healthy men and women aged 18–65 who are mentally and physically able to participate and who are not taking prescription medications or recently treated with antibiotics are ideal candidates.
Not a fit: People with chronic gut, heart, liver, kidney, or immune disorders, those who recently used antibiotics, pregnant or breastfeeding individuals, or those on prescription medications are unlikely to be eligible or to benefit from this pilot supplementation.
Why it matters
Potential benefit: If successful, short-term IPA supplementation could raise regulatory T cells or BDNF and point to a new approach for supporting immune regulation and brain health.
How similar studies have performed: Preclinical in vitro and animal studies suggest IPA can modulate inflammation, metabolism, and BDNF, but human data are limited and this pilot human supplementation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy women and men ≥18 and ≤65 years of age * Deemed mentally and physically able to participate Exclusion Criteria: * Diagnosis of gut-, heart-, liver-, kidney or immune-related disorders * Use of antibiotics within the last month * Pregnancy, lactation or childbirth within the last five months * Use of prescription medication
Where this trial is running
Glostrup Municipality
- Optic Neuritis Clinic, Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet-Glostrup — Glostrup Municipality, Denmark (Recruiting)
Study contacts
- Principal investigator: Jette Frederiksen, Prof, MD — Copenhagen University Hospital, Rigshospitalet-Glostrup
- Study coordinator: Moschoula Passali, MSc, PhD
- Email: moschoula.passali@regionh.dk
- Phone: +45 38633467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.