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

Glostrup University Hospital, Copenhagen

Status: Enrolling

Conditions: Healthy

Treatments: Dietary Supplement: Indole-3-propionic acid (IPA); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07105514

H-24008127 - 116180

Details and patient eligibility

About

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.

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: 32 estimated 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
• Pregnancy, lactation or childbirth within the last five months
• Use of prescription medication

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo

Indole-3-propionic acid (IPA)

Experimental group

Description:

IPA: total daily dose of 1000 mg

Treatment:

Dietary Supplement: Indole-3-propionic acid (IPA)