Indole-3-PROpionic Acid Clinical Trials - a Pilot Study Part 2
NCT ID: NCT07105514
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
32 participants
INTERVENTIONAL
2025-08-04
2026-06-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Placebo
Placebo
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.
Indole-3-propionic acid (IPA)
IPA: total daily dose of 1000 mg
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Deemed mentally and physically able to participate
Exclusion Criteria
* Use of antibiotics within the last month
* Pregnancy, lactation or childbirth within the last five months
* Use of prescription medication
18 Years
65 Years
ALL
Yes
Sponsors
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University of Copenhagen
OTHER
University of Southampton
OTHER
Glostrup University Hospital, Copenhagen
OTHER
Responsible Party
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Jette Lautrup Frederiksen
Prof, DMSc, MD
Principal Investigators
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Jette Frederiksen, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital, Rigshospitalet-Glostrup
Locations
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Optic Neuritis Clinic, Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet-Glostrup
Glostrup Municipality, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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H-24008127 - 116180
Identifier Type: -
Identifier Source: org_study_id
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