Clinical Proof-of-concept Study on Immunological Effects of Consuming Increasing Doses of a Natural Peptide in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Changes to ex vivo PHA-mediated Th-17 cytokine secretion
研究概览
简要总结
A trial monitoring the immune effects in 24 people with 4 different doses (1 gram per day, 2 grams per day, 4 grams per day, 8 grams per day) of a natural plant-based protein hydrolysate.
详细描述
The goal for this clinical proof-of-concept study is to compare immune effects of a novel plant-based peptide on IL-17, Th17 and related immunological mechanisms.
An open-label, escalating dose study design monitoring immune effects in which healthy men and women take doses of a natural protein hydrolysate daily for 6 weeks.
During the first 2 weeks, participants will consume 1 gram/day. For the next 2 weeks, participants will consume 2 grams/day. For the final 2 weeks, participants will be randomly assigned to consume either 4 grams/day or 8 grams/day.
Blood samples are collected at baseline and every 2 weeks. The blood will be used for testing of the numbers of T lymphocytes that secrete Interleukin-17 after ex vivo cell cultures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •24 men and women
- •Eating a typical diet that does not exceed an estimated average of 9 grams of salt per day;
- •Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements;
- •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.
排除标准
- •Previous major gastrointestinal surgery Vaccination during past month;
- •Vaccination planned during study;
- •Cancer during past 12 months;
- •Chemotherapy during past 12 months;
- •Diagnosed with an autoimmune disorder;
- •Diagnosed with obstructive sleep apnea syndrome (OSAS);
- •Currently taking medication containing Levodopa (L-dopa);
- •Having received a cortisone shot within the past 6 months;
- •Taking anti-inflammatory medications on a daily basis;
- •Currently experiencing intense stressful events/life changes;
- •Currently in intensive athletic training (such as marathon runners);
- •An unusual sleep routine
- •Changes to nutritional supplements during the past month;
- •Currently taking Vitamin D at a dose higher than 1,000 IU/day;
- •Currently taking omega-3 at a dose higher than 1 gram/day;
- •Unwilling to maintain a constant intake of supplements over the duration of the study;
- •Women of childbearing potential: Pregnant, nursing, or trying to become pregnant;
- •Known food intolerances related to ingredients in active test product.
结局指标
主要结局
Changes to ex vivo PHA-mediated Th-17 cytokine secretion
时间窗: 2 weeks, 4 weeks, 6 weeks
Ex vivo PBMC cultures with the mitogen PHA, followed by testing of cytokine production using a Th-17 Luminex array.
次要结局
- Evaluation of lymphocytes(2 weeks, 4 weeks, 6 weeks)
研究者
Gitte Jensen, Ph.D.
Research Director
Natural Immune Systems Inc