RecruitingNot ApplicableNCT07105514

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

Indole-3-PROpionic Acid Clinical Trials - a Pilot Study Part 2 (iPROACT-pilot2)


Sponsor

Glostrup University Hospital, Copenhagen

Enrollment

32 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

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

Exclusion Criteria4

  • 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

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Interventions

DIETARY_SUPPLEMENTIndole-3-propionic acid (IPA)

Two capsules are taken every morning and two capsules are taken every evening for 14 consecutive days. Active capsules are taken orally and contain 250 mg of IPA each.

DIETARY_SUPPLEMENTPlacebo

Two capsules are taken every morning and two capsules are taken every evening for 14 consecutive days. Placebo capsules are taken orally and contain maltodextrin.


Locations(1)

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

Glostrup Municipality, Denmark

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NCT07105514


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