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

Condition(s) studied

Investigational drug(s) / intervention(s)

Indole-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.

Placebo: 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.

Study 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

Primary outcome measure(s)

• Regulatory T cells (first primary outcome) — Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).
  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.
• Brain-derived neurotrophic factor (second primary outcome) — Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).
  Brain-derived neurotrophic factor measured in platelet-free plasma samples using ELISA or mesoscale.

Trial sites (1)

More Glostrup University Hospital, Copenhagen trials in Denmark

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