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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

• Regulatory T cells (first primary outcome) [Срок оценки: 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) [Срок оценки: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).]

Вторичные конечные точки (12)

• Th1/Th2 ratio in PBMCs [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).]
• CRP [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Results from samples taken on day 15 and adjusted for results from day 1.]
• 8-oxo-dG [Срок оценки: Results from samples taken on day 15 and adjusted for results from day 1.]
• Serum metabolomics [Срок оценки: 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 [Срок оценки: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).]

Критерии участия

Критерии включения

• Healthy women and men ≥18 and ≤65 years of age
• Deemed mentally and physically able to participate

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Дания · 1 центр

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

Идентификаторы

NCT: NCT07105514 · H-24008127 - 116180

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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