Indole-3-PROpionic Acid Clinical Trials - a Pilot Study (iPROACT-pilot)

Glostrup University Hospital, Copenhagen

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Indole-3-propionic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06674018

H-24008127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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
• Pregnant or lactating women or birth within the last five months
• Use of medicine that requires prescription

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo

50 mg IPA

Experimental group

Description:

50 mg indole-3-propionic acid

Treatment:

Dietary Supplement: Indole-3-propionic acid

120 mg IPA

Experimental group

Description:

120 mg indole-3-propionic acid

Treatment:

Dietary Supplement: Indole-3-propionic acid

500 mg IPA

Experimental group

Description:

500 mg indole-3-propionic acid

Treatment:

Dietary Supplement: Indole-3-propionic acid