Influence of Vitero Supplementation (Rice-Pea-Blueberry Sport Gel Formulation) on Exercise-Induced Oxinflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Plasma concentrations of inflammasome ASC oligomers
研究概览
简要总结
This study is the human clinical trial component of an SBIR grant with Sinnovatek (funded). Cyclists (n=20) will consume a blueberry-protein, blueberry, or placebo supplement for 2 weeks prior to cycling for 2.5 h at high intensity. Washout periods (2 weeks) will separate the 3 trials, and the cyclists will crossover (randomized) to one of the two others supplements for 2 weeks, and then engage in additional 2.5 h cycling bouts. Blood and urine samples will be collected pre- and post-supplementation for each of the 3 trials. Blood samples will also be collected immediately after and 1.5h- and 24h-post-exercise. Blood samples will be analyzed for inflammation and oxidative stress outcomes. Urine samples will be analyzed for blueberry gut-derived phenolics.
详细描述
PURPOSE: To investigate the influence of 2-weeks blueberry, blueberry-protein, versus placebo gel supplementation (randomized, crossover) on oxinflammation markers and blueberry gut-derived phenolics after 2.5 h intensive cycling exercise in 20 subjects.
HYPOTHESIS: We hypothesize that 2-weeks blueberry or blueberry-protein polyphenol (500 mg/day) versus placebo gel supplementation will attenuate post-exercise increases in inflammation and oxidative stress biomarkers.
RESEARCH PROCEDURES The research procedures will be conducted at the Human Performance Laboratory (Room 1201, Plants for Human Health Institute Building, 600 Laureate Way), operated by Appalachian State University at the North Carolina Research Campus (NCRC) in Kannapolis, NC. Subjects will come to the lab for orientation/baseline testing with pre-supplementation blood sample collections, three 2.5 h cycling sessions, and additional lab visits to provide 1-day 7:00 am recovery blood samples) (thus 9 total lab visits). The total amount of time subjects will be asked to volunteer for this study is about 20 hours at the Human Performance Laboratory (over a 10-week period).
Orientation/Baseline Testing (Lab Visit #1) Two weeks prior to the 2.5 h cycling session, subjects will report to the Human Performance Laboratory at approximately 7:00-8:00 am. A blood sample will be collected in an overnight fasted state to coincide with the same time of the day for the post-supplementation blood draw. Study participants will be tested for maximal aerobic capacity (VO2max) during a graded, cycle ergometer test with the Cosmed CPET metabolic device (Cosmed, Rome, Italy). Body composition will be measured with the seca BIA and Bod Pod body composition analyzer (Life Measurement, Concord, CA). Demographic and training histories will be acquired with questionnaires. Gel blueberry, blueberry protein, or placebo supplements will be supplied. 3-day food records will be supplied with thorough instructions. Participants will be given two 24-h urine collection kits with thorough written and oral instruction on collection procedures. The first 24-h urine collection bottle will be collected during the 24-h period immediately after lab visit #1 and turned in the next morning. Supplementation will start right after the urine is turned in. The second 24-h urine collection bottle will be collected during the 24-h period immediately prior to lab visit #2. Subjects will collect every drop of urine in the collection bottle for 24 hours.
2-Week Supplementation Periods Study participants will be randomized to Vitero (rice-pea-blueberry) gel, blueberry gel, and placebo gel trials, with supplements ingested daily for 2-weeks prior to participation in the first 2.5 h cycling session. After a 2-week washout period, participants will repeat all procedures two more times using the counterbalanced supplements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Investigators and study participants will be blind to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female.
- •Ages 18-65 years.
- •Non-smoker.
- •Regularly compete in road races (category 1 to 5) and/or are capable of cycling 2.5 h in a laboratory setting (using their own bicycles on Saris training systems).
- •Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, herbs, and medications that influence inflammation and immune function (especially Advil, Motrin, aspirin, and similar anti-inflammatory drugs) for the duration of the 6-week study. (Review supplement and medication use with the Research Manager during orientation).
- •Categorized as "low risk" using the American College of Sports Medicine screening questionnaire.
- •Generally healthy and without chronic disease including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 and 2 diabetes, rheumatoid arthritis.
排除标准
- •Inability to comply with study requirements.
- •Body weight below 100 pounds.
- •Pregnant or breastfeeding.
- •Any other concurrent condition which, in the opinion of the primary investigator (PI), would preclude participation in this study or interfere with compliance.
- •Current diagnosis of cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).
- •History of allergic reactions to blueberries.
结局指标
主要结局
Plasma concentrations of inflammasome ASC oligomers
时间窗: Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, and 24 hours-post-exercise
ASC oligomers are an indicator of inflammasome activation
次要结局
- Plasma concentrations of 4-hydroxynonenal(Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, and 24 hours-post-exercise)
- Urine concentrations of hippuric acid(Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, and 24 hours-post-exercise)