A Randomized Controlled Trial of Oral Suplementation With AM3, Hesperidin and Spermidine on Immunity Response and Biological Age in Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in Biological Age
研究概览
简要总结
The goal of this interventional study is to know the immune status of healthy participants and to obtain their biological age before and after two months of ingesting a dietary supplement. These individuals are compared with others who will be given a product of similar appearance, but without containing active components, being the constituents of the placebo group.
The study has a duration of 8 weeks, with 2 interventional visits (complete blood samples will be collected) at baseline and at 8 weeks.
In order to be included in the trial, the patient must read the Patient Information Sheet and sign the informed consent form.
The dosage regimen is two capsules per day in a single dose.
详细描述
Forty consenting volunteers will be included in this prospective, randomized, double-blind study and will be randomized by a statistician independent of the research team.
The study consists of two milestones, in which different parameters are evaluated to finally reach the main goal, to measure their immune status and their biological age after taking the supplement (whose active ingredients include AM3, polyamines and flavonoids):
- Complete blood samples are collected from participants at milestone 1. To determine immune functions; neutrophils, lymphocytes and NK cells are measured. The adherence and chemotaxis capacity of neutrophils and lymphocytes is determined, as well as neutrophil phagocytosis and lymphocyte proliferation. In addition, the release of pro-inflammatory and anti-inflammatory cytokines is assessed.
In parallel, each participant will be given a survey to assess their perception of stress, which they will have to complete before and after 2 months of ingestion of the product (experimental and placebo).
- In milestone 2, oxidative and inflammatory stress parameters are analyzed. Regarding oxidative stress: catalase activity, glutathione reductase activity and reduced glutathione concentration are measured. In terms of inflammatory stress: concentrations of both proinflammatory and anti-inflammatory cytokines released are measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 29 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers who give their consent for the study will be included after having read and understood the information provided in the informed consent document
- •Between 29-65 years old
- •Residents in the Community of Madrid
排除标准
- •Volunteers with no allergies or intolerances to the product
- •Patologies
- •Excessive alcohol consumption
- •Pregnant women
- •Antioxidants intake from supplements
结局指标
主要结局
Change in Biological Age
时间窗: Baseline and Week 8
The Biological Age will be determined at baseline and week 8, by using the mathematical model 'Immunity Clock', based on the the natural killer activity, Lymphoproliferation and phagocytosis, and neutrophils and lymphocyts chemotaxis
次要结局
- Change in Glutathione peroxidase levels(Baseline and week 8)
- Change in Glutathione reductase levels(Baseline and week 8)
- Change in cytotoxic activity of natural killer(Baseline and week 8)
- Change in phagocytosis activity(Baseline and week 8)
- Change in catalase activity with the use of a spectrophotometer(Baseline and week 8)
- Change in inflammatory and anti-inflammatory cytokines levels(Baseline and week 8)
- Change in Malondialdehyde concentrations(Baseline and week 8)
- Change in neutrophil levels(Baseline and week 8)
- Change in reduced/oxized glutathione concentrations (GSH/GSSG)(Baseline and week 8)
- Change in lymphocyte levels(Baseline and week 8)
- Change in lymphoproliferation levels(Baseline and week 8)
- Change in chemotaxis index(Baseline and week 8)