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Recruiting NCT07105514

NCT07105514 Indole-3-PROpionic Acid Clinical Trials - a Pilot Study Part 2

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Clinical Trial Summary
NCT ID NCT07105514
Status Recruiting
Phase
Sponsor Glostrup University Hospital, Copenhagen
Condition Healthy
Study Type INTERVENTIONAL
Enrollment 32 participants
Start Date 2025-08-04
Primary Completion 2025-10-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
Indole-3-propionic acid (IPA)Placebo

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 32 participants in total. It began in 2025-08-04 with a primary completion date of 2025-10-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The goal of this trial is to investigate the biological effects of oral supplementation with indole-3-propionic acid (IPA) taken twice daily in healthy adults. The main scientific questions are: * Does supplementation with IPA increase the abundance of 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? Participants will: * Take capsules to achieve a total daily dose of 1000 mg of IPA or placebo: 500 mg every morning and 500 mg every evening for 14 days. * Visit the clinic at the beginning (day 1) and at the end (day 15) of the supplementation period to deliver blood, urine and fecal samples, have simple measurements performed, fulfil questionnaires and report any side effects.

Eligibility 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

Contact & Investigator

Central Contact

Moschoula Passali, MSc, PhD

✉ moschoula.passali@regionh.dk

📞 +45 38633467

Principal Investigator

Jette Frederiksen, Prof, MD

PRINCIPAL INVESTIGATOR

Copenhagen University Hospital, Rigshospitalet-Glostrup

Frequently Asked Questions

Who can join the NCT07105514 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07105514 currently recruiting?

Yes, NCT07105514 is actively recruiting participants. Contact the research team at moschoula.passali@regionh.dk for enrollment information.

Where is the NCT07105514 trial being conducted?

This trial is being conducted at Glostrup Municipality, Denmark.

Who is sponsoring the NCT07105514 clinical trial?

NCT07105514 is sponsored by Glostrup University Hospital, Copenhagen. The principal investigator is Jette Frederiksen, Prof, MD at Copenhagen University Hospital, Rigshospitalet-Glostrup. The trial plans to enroll 32 participants.

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