Acute Effects on Stem Cell Surveillance

Официальное название

Clinical Trial on Rapid Effects on Stem Cell Surveillance. A Randomized Placebo-controlled Acute Cross-over Trial.

Обзор

The goal for this clinical trial is to compare acute immune effects of three nutraceutical ingredients and blends to a placebo.

Подробное описание

The goal for this clinical trial is to compare acute immune effects of anthocyanin-rich botanical extracts and blends to a placebo.

Stem cell mobilization and homing will be evaluated through monitoring of changes to the numbers of various types of stem cells in the blood circulation.

The testing will show whether consuming the active test products lead to changes in stem cell numbers in circulation above the normal circadian changes for each participant. The normal circadian changes are documented on the clinic visit where placebo is consumed. Several different stem cell populations will be evaluated using flow cytometry.

Вмешательства

• Пищевая добавка Anthocyanin-rich berry extract
  0.5 grams
• Пищевая добавка Anthocyanin-rich flower/leaf extract
  0.5 grams
• Пищевая добавка Berry /leaf blend
  0.5 grams
• Пищевая добавка Placebo
  Placebo (white rice-based)

Первичные конечные точки

• Stem cell surveillance [Срок оценки: Baseline, 1 hour, 2 hours after consumption]

Вторичные конечные точки (1)

• Serum cytokine levels [Срок оценки: Baseline, 1 hour, 2 hours after consumption]

Критерии участия

Критерии включения

• Healthy adults;
• Age 18-75 years (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, 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 anxiolytic, hypnotic, or anti-depressant prescription medication;
• 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.

Prescription medication will be evaluated on a case-by-case basis.

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

Фундаментальное исследование

Центры проведения

США · 1 центр

• NIS Labs — Klamath Falls

Идентификаторы

NCT: NCT07341178 · 211-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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