Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06674018
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2024-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Indole-3-PROpionic Acid Clinical Trials - a Pilot Study
Sponsor:
Glostrup University Hospital, Copenhagen
Organization:
Study Overview
Official Title:
Indole-3-PROpionic Acid Clinical Trials - a Pilot Study (iPROACT-pilot)
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iPROACT-pilot
Brief Summary:
The goal of this pilot intervention trial is to investigate the biological effects of daily supplementation with different doses of indole-3-propionic acid (IPA) in healthy adults. The main scientific questions are:
* Does supplementation with IPA increase the abundance 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?
* How big a dose of IPA is necessary to achieve the above benefits?
Participants will:
* Take 50 mg IPA or 120 mg IPA or 500 mg IPA or placebo every morning for 14 days.
* Visit the clinic at the beginning (day 1) and at the end (day 15) of IPA supplementation to deliver blood, urine and fecal samples, have simple measurements performed, fulfil questionnaires and report any side effects.
* Does supplementation with IPA increase the abundance 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?
* How big a dose of IPA is necessary to achieve the above benefits?
Participants will:
* Take 50 mg IPA or 120 mg IPA or 500 mg IPA or placebo every morning for 14 days.
* Visit the clinic at the beginning (day 1) and at the end (day 15) of IPA supplementation 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: