Nutritional-Based Strategy to Counter Exercise-Induced Muscle Damage and OxInflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Serum concentration of creatine kinase
研究概览
简要总结
The purpose of this study is to measure the effect of using a turmeric-based supplement for 2-weeks on muscle damage and soreness that occur in the body after 90-minutes of exercise. Participants will first come to the human performance lab (HPL) for orientation and pre-study fitness tests including muscular fitness and body composition. Participants will be randomized to turmeric or placebo groups, and take 2 tablets of the supplements each day for the first two weeks. Participants will report back to the HPL on a Monday to engage in weight lifting and calisthenics for 90 minutes. Fitness tests (vertical jump, bench press, leg-back lift for strength, 30-second cycling sprint test) and blood samples will be given and collected before and after this exercise session. Participants will then come back to the HPL each morning, Tuesday through Friday, in the early morning to provide blood samples and retake the fitness tests. This study will entail seven HPL visits over a 3-week period.
详细描述
Orientation, Supplementation, and Basic Study Procedures (Visit #1): Participants will first come to the Human Performance Lab (600 Laureate Way, North Carolina Research Campus, Kannapolis, NC) for an orientation to study procedures. This will include a review of the consent form, completion of basic questionnaires, and an introduction to the eccentric muscle exercise bout and the strength/power performance testing protocol (about 1.5 hours) (visit #1). This will be followed by another lab session for pre-study measurements and sample collection (visit #2). Participants will be randomized to turmeric or placebo groups, and provided a 2-weeks supply of supplements (in supplement trays). Participants will consume 2 tablets each day in the morning just prior to breakfast. The supplement and placebo tablets will look the same. The supplements will have codes. Participants and the staff will not know what are in the tablets until the study is over. The supplement is called "Turmeric Strength for Joint" and is sold by the study sponsor (MegaFood). For purposes of this study, the supplement will be called "turmeric". The ingredients are healthy and include turmeric root extract, black pepper extract, boswellia gum resin extract, devil's claw root extract, and ginger root. The turmeric supplement provides a minimum of 300 mg curcumin. Compliance to the supplement plan will be checked weekly through email correspondence from the Research Manager. A 3-day food record will be collected during the end of the 2-week supplementation period to assess the participants' background diet.
The study will include 5 other lab visits during a one-week period starting on a Monday (visit #3), with morning visits at about 7:00 am on Tuesday through Friday (visits 4-7). At each of the 7 lab visits, participants will come to the lab at 7:00 am not having consumed food or beverages (other than water) for at least the previous 9 hours, and having abstained from vigorous exercise for at least the previous 24-48 hours. The Monday session will take about 2.5 hours (7:00 to 9:30 am), and the Tuesday through Friday sessions will take about 30-45 minutes each. The total amount of time participants will be asked to volunteer for this study is about 8-9 hours at the performance lab. Seven blood samples will be collected and analyzed for various measures of muscle damage, inflammation, and oxidative stress. After each of the blood draws, participants will complete the Profile of Mood States (POMS) questionnaire to gauge mood, energy, and vitality. Participants will also provide a delayed onset of muscle soreness (DOMS) rating. Two urine samples will be collected (before and after the 2-week supplementary period) and analyzed for key metabolic markers of turmeric ingestion.
Baseline Testing (Visit #2) Participants will come to the lab at 7:00 am in an overnight fasted state dressed in exercise clothes. Participants will provide a blood sample. A trained phlebotomist will collect a maximum of 35 ml blood (a little over 2 tablespoons). Participants will also provide a spot urine sample in a private location in the restroom. Participants will collect a mid-stream urine sample in a disposable urine cup. Height, body weight, and body composition will be measured in a private section of the lab. Bioelectrical impedance (BIA) using the seca BIA scale will be used to assess body composition (i.e., the percent of body weight that is fat tissue) and body weight. Participants will remove shoes and socks and stand with bare feet on the seca scale for about 7-10 seconds while grasping side rails with their hands. Percent body fat will also be measured using the BodPod. Participants will sit inside the BodPod with a tight-fitting swim suit for about 10 minutes while body fat is calculated.
The Profile of Mood States (POMS) (short version, 40 items) is a rating scale to assess "right now" mood states, energy, and vitality. Participants will also provide a rating of delayed onset of muscle soreness (DOMS) using a 1-10 scale.
Participants will perform some light exercises to warm up, followed by four muscle function tests: vertical jump, bench press, leg-back strength, and anaerobic power through the 30-second Wingate test.
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
- Double (Participant, Investigator)
盲法说明
Coded, capsules
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, ages 18-50 years.
- •Non-smoker.
- •Body mass index less than 35 kg/m2 (below moderate or severe obesity).
- •Not engaged in regular resistance training (less than 3 sessions per week).
- •Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, protein supplements, herbs, and medications that influence inflammation and immune function (especially Advil, Motrin, aspirin, and similar anti-inflammatory drugs) for the duration of the study. (You will review your 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.
- •Engaged in regular resistance training (3 or more sessions per week, on average).
- •Body weight below 110 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 turmeric, devil's claw, boswellia extract, or ginger extract.
结局指标
主要结局
Serum concentration of creatine kinase
时间窗: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after
Muscle damage biomarker
次要结局
- Plasma concentration of 4-hydroxynonenal (4HNE)(Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
- Bench press repetitions(Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
- Plasma concentration of IL-6(Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
- Serum concentration of cortisol(Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
- Rating of Delayed onset of muscle soreness(Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
- Serum concentration of myoglobin(Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
- Serum concentration of C-reactive protein(Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
- Urine concentration of curcuminoid metabolites(Change from pre-to-post-supplementation, 2 week period)
- 30-second Wingate cycle test watts(Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
- Vertical jump height(Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
- Leg-back strength kilograms(Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
- Rating of Profile of Mood States (POMS)(Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
