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Идёт набор NCT07733362

Assessment of the Immunomodulatory Potential of Spirulina Blue Protein Capsule on Immunomodulation in Healthy Volunteers

Без фазы С лечением Healthy Volunteers Immune System

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Spirulina capsules.
Кому может быть актуально
Состояния в реестре: Healthy Volunteers, Immune System. Базовые параметры: 25 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Таиланд
Следующий шаг
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Официальное название

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunomodulatory Potential and Safety of Spirulina Blue Protein Capsules in Healthy Volunteers

Обзор

This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and immunomodulatory effects of Spirulina Blue Protein capsules in healthy adults. Participants will be randomly assigned to receive placebo, 200 mg/day, or 1,000 mg/day of Spirulina Blue Protein capsules for 12 weeks. The study will assess changes in immune cell populations (CD4+, CD8+, and natural killer cells), circulating cytokine levels, hematological and biochemical parameters, and the occurrence of adverse events. The findings will provide evidence regarding the safety and potential immunomodulatory benefits of Spirulina Blue Protein supplementation in healthy individuals and support the development of evidence-based functional food and nutraceutical products.

Подробное описание

Spirulina Blue Protein (SBP) from Arthrospira platensis or Spirulina platensis, which is rich in the bioactive pigment-protein phycocyanin, has demonstrated antioxidant, anti-inflammatory, and immunomodulatory activities in preclinical studies. Previous in vitro investigations have shown that SBP can enhance immune cell function and modulate cytokine production; however, evidence regarding its safety and immunomodulatory effects in healthy humans remains limited. This study aims to evaluate the safety and immunomodulatory potential of SBP capsules in healthy adults under controlled clinical conditions.

This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Healthy adults aged 25-60 years will be randomly assigned three groups: placebo, SBP 200 mg/day, or SBP 1,000 mg/day. Participants will receive the assigned intervention orally for 12 weeks.

The primary objective is to evaluate the effects of SBP supplementation on immune function by assessing changes in immune cell populations and circulating cytokine levels after 12 weeks of intervention. Safety will be evaluated through the monitoring of adverse events, vital signs, complete blood count, and clinical chemistry parameters, including liver and kidney function tests. Secondary assessments include changes in hematological and biochemical parameters and tolerability of the study product.

Blood samples will be collected before and after the intervention to evaluate immune cell populations (CD4+ T cells, CD8+ T cells, and natural killer cells) and circulating cytokines, including interleukin-2 (IL-2), interleukin-6 (IL-6), interferon-gamma (IFN-γ), and tumor necrosis factor-alpha (TNF-α). Participants will also undergo routine safety assessments throughout the study.

The results of this trial will provide clinical evidence regarding the safety and immunomodulatory effects of Spirulina Blue Protein supplementation in healthy adults and will support the development of evidence-based functional foods and nutraceutical products.

Вмешательства

  • Пищевая добавка Spirulina capsules
    Spirulina Blue Protein Capsule

Первичные конечные точки

  • Change in Peripheral Blood Immune Cell Subsets [Срок оценки: 12 weeks]
Вторичные конечные точки (1)
  • Change in Serum Cytokine Concentrations [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Healthy male or female adults aged 25-60 years.
  • Body mass index (BMI) between 18.5 and 24.9 kg/m².
  • Able and willing to provide written informed consent.
  • Willing and able to comply with all study procedures and scheduled visits

Критерии исключения

  • History of diseases affecting the immune system or metabolism, including cardiovascular disease, diabetes mellitus, liver disease, kidney disease, autoimmune disorders, or chronic inflammatory diseases.
  • Abnormal laboratory findings outside the reference range, including complete blood count, liver function tests, or renal function tests.
  • Current use of medications or dietary supplements that may affect the study outcomes.
  • Known allergy to Spirulina, algae-containing dietary supplements, or any component of the study capsules.
  • Pregnant or breastfeeding women.

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
Тройное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Таиланд · 1 центр
  • School of Medical Sciences, University of Phayao — Phayao

Идентификаторы

NCT: NCT07733362 · HREC-UP-2026-001 · UP401/2569 · TCTR20260719002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗