A Single Center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Ability of a Euglena Beta Glucan Supplementation to Augment Immune Function in Endurance Athletes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence of upper respiratory tract infections
研究概览
简要总结
Upper respiratory tract infections cause cold and flu-like symptoms and are the most common form of acute illness. Certain populations are at increased risk of upper respiratory tract infections including athletes who train at a high level of intensity for prolonged periods of time. Consequently, some athletes experience higher rates of cold and flu-like symptoms than the general population.
Euglena gracilis is a micro-algae which can synthesize many nutrients necessary for human health, including insoluble beta glucan. Thus, intake of whole cell Euglena may be beneficial to athletes by providing essential vitamins to optimize immune function.
详细描述
At screening, an informed consent form will be given to the potential volunteer. They will be required to read the information and be given the opportunity to seek more information if needed, or provided with the option of taking the consent form home to review prior to making their decision. If agreeable, the volunteer will sign the consent form and receive a duplicate of the signed copy. Once consent has been obtained, the screening visit will proceed.
Screening assessments include:
- Review of medical history, concomitant therapies and current health status (weight, height, BMI, vital signs, safety blood work)
- Assesses inclusion and exclusion criteria
- Urine pregnancy test for female potential participants that are not post-menopausal
Eligible participants will return to the clinic for baseline assessments. Baseline (day 0) assessments include:
- Review of concomitant therapies and current health status
- Review pre-supplement emergent AEs
- Reassess inclusion and exclusion criteria
- Randomization of eligible participants
- Dispense daily upper respiratory tract symptom questionnaire
- Collect saliva sample for measurement of secretory IgA
- Collect blood sample for the analysis of cell activity
- Administer mood and stress questionnaire in-clinic
- Dispense daily gastrointestinal and bowel questionnaire
- Dispense investigational product and instruct participants on use
- Dispense daily study diary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All parties, except an outside person not involved in the study, will be blinded to the treatment conditions
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
- •Body Mass Index (BMI) > 18 kg/m2 to <35 kg/m
- •Willing to comply with a wash-out period for nutritional supplements known to affect immune function and to not consume these supplements for the entire study period
- •Females of childbearing potential must agree to use a medically approved method of birth control
- •Agree to maintaining a consistent diet and lifestyle routine throughout the study
- •An endurance training athlete
- •Healthy as determined by laboratory results and medical history
排除标准
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- •Verbal confirmation of previous major gastrointestinal surgery
- •Consuming doses of beta-glucan-containing nutritional supplements
- •Chronic consumption of anti-inflammatory medications
- •Taking antibiotics within 4 weeks of screening and during the study period
- •Verbal confirmation of a diagnosed chronic inflammatory condition or autoimmune disorder
- •Verbal confirmation of Type I or Type II diabetes or clinically important renal, hepatic, cardiac, pulmonary, pancreatic, neurologic, or biliary disorder, or a recent history (prior 2 years) of cancer other than non-melanoma skin cancer
- •Currently taking antipsychotic medications
- •Chronic recurring respiratory signs and symptoms due to allergies (including seasonal allergies) or chronic bronchitis, asthma, or wheezing
- •Use of immunomodulators (including corticosteroids) such as immunosuppressant or immunostimulant medications within 4 weeks of baseline and during the study period
- •Chronic use of Antacids and Proton Pump Inhibitors (PPI)
- •Individuals who have received or are planning to receive the flu vaccination for the current flu season
- •Active infection or signs/symptoms of an acute infection
- •Heavy use of tobacco
- •Alcohol or drug abuse within the last 2 years
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
Treatment
Whole Cell Euglena delivering βeta Glucan
干预措施: Whole Cell Euglena containing Beta Glucan (Dietary Supplement)
结局指标
主要结局
Incidence of upper respiratory tract infections
时间窗: ANOVA of 90 day supplementation
incidence of very mild/mild/ moderate/ severe upper respiratory tract infection symptoms
次要结局
- Symptom Duration(30 and 90 days)
- Stress(90 days)
- Secretory IgA(90 days)
- Natural Killer (NK) Cell Population(90 days)
- Gastrointestinal status(30 and 90 days)