Rapid Response of Stem Cells and Immune Cells for Efficacy

Официальное название

Rapid Response of Stem Cells and Immune Cells for Efficacy: An Acute Randomized Double-blind Placebo-controlled Cross-over Trial

Обзор

The goal for this clinical trial is to compare rapid effects of four products on stem cells, immune activation, and mitochondrial function. A double-blind, placebo-controlled, cross-over study design will be used.

Подробное описание

This clinical trial aims at documenting acute effects of consuming four products through evaluation of stem cell surveillance and mitochondrial resilience.

Data on stem cell trafficking will be collected. The testing will show whether consuming the products leads to a rapid change in stem cell surveillance. Data on cellular energy production and mitochondrial resilience in white blood cells under oxidative and inflammatory stress ex vivo will be collected. This testing will show whether consuming the test products leads to support of energy production within mitochondria, under normal and stressed conditions.

Вмешательства

• Пищевая добавка Placebo
  2 capsules
• Пищевая добавка Chaga Mushroom
  2 capsules
• Пищевая добавка Ginseng extract
  2 capsules
• Пищевая добавка Olive extract
  2 capsules
• Пищевая добавка Potassium Hydrogen Glucarate
  2 capsules

Первичные конечные точки

• Stem cell trafficking [Срок оценки: Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug]

Вторичные конечные точки (2)

• Mitochondrial volume per cell [Срок оценки: Baseline. 1 hour, 2 hours, 3 and hours after ingestion of study drug]
• Mitochondrial membrane potential per cell [Срок оценки: Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug]

Критерии участия

Критерии включения

• Healthy adults;
• Age 18 - 75 years (inclusive);
• BMI between 18.0 and 34.9 (inclusive);
• Veins easy to see in one or both arms (to allow for the multiple blood draws);
• Willing to comply with study procedures, including:

• Maintaining a consistent diet and lifestyle routine throughout the study,
• Consistent habit of bland breakfasts on days of clinic visits,
• Abstaining from exercising and nutritional supplements on the morning of a study visit,
• Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit;
• Abstaining from music, candy, gum, computer/cell phone use (airplane mode is allowed), during clinic visits.

Критерии исключения

• Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);
• Taking anti-inflammatory medications on a daily basis;
• Currently experiencing intense stressful events/ life changes;
• Currently in intensive athletic training (such as marathon runners);
• Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
• An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
• Unwilling to maintain a constant intake of supplements over the duration of the study;
• Anxiety about having blood drawn;
• Pregnant, nursing, or trying to become pregnant;
• Known food allergies related to ingredients in active test product or placebo.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• NIS Labs — Klamath Falls

Идентификаторы

NCT: NCT07127705 · 186-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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