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Recruiting NCT07105514

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

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indole-3-propionic acid (IPA), Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Dietary supplement 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.
  • Dietary supplement 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.

Primary outcome measures

  • Regulatory T cells (first primary outcome) [Time frame: 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 (second primary outcome) [Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).]
Secondary outcome measures (12)
  • Th1/Th2 ratio in PBMCs [Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).]
  • Th17/mTreg ratio in PBMCs [Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).]
  • Th17.1 cells in PBMCs [Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).]
  • CRP [Time frame: Results from blood samples taken on day 15 (just before last supplement/placebo dose) and adjusted for results from day 1 (just before first supplement/placebo dose).]
  • Triglycerides [Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).]
  • non-HDL cholesterol [Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).]
  • C-peptide [Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).]
  • Fasting glucose [Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).]
  • F2-isoprostanes [Time frame: Results from samples taken on day 15 and adjusted for results from day 1.]
  • 8-oxo-dG [Time frame: Results from samples taken on day 15 and adjusted for results from day 1.]
  • Serum metabolomics [Time frame: Four samples in total. Day 1 prior to and again 1.5 hour after intake of first capsule of IPA/ placeblo. Day 15 prior to and again 1.5 hour after intake of last capsule of IPA/ placebo.]
  • Total cholesterol [Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Optic Neuritis Clinic, Danish Multiple Sclerosis Center, Department of Neurology, Copenhag — Glostrup Municipality

Identifiers

NCT: NCT07105514 · H-24008127 - 116180

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗