Effects of INDUS810 on Body Composition, Muscular Performance, and Training Adaptations During 12-weeks of Supplementation and Concurrent Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Body composition
研究概览
简要总结
The purpose of this 12-week, interventional study is to determine the effects of oral supplementation with Indus810 (dietary supplement with active ingredient Fenugreek) on body composition, muscular performance, and training adaptations
详细描述
This 12-week study is a randomized, parallel-group, placebo-controlled, clinical trial of N=66 recreationally, but normal to moderately overweight/obese male subjects to be recruited at a single investigational center in Northeast Ohio (i.e. The Center for Applied Health Sciences).
Subjects will attend 4 study visits. At Visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work, background baseline diet). At Visits 2 (day 0 - Baseline Testing), and 4 (week 12), measurements of various hemodynamic, hematologic & biochemical biomarkers of safety (Total testosterone, CBC, and comprehensive metabolic panel) will be made. At Visits 2, 3, and 4, the following efficacy measures will be obtained: Body Composition assessment via DEXA, Upper and Lower Body Performance testing on a Smith Machine and a TENDO unit utilizing the bench press and squat exercises, and anchored 100mm VAS scales (for various psychometric indices). In addition, a comprehensive side effect profile/ adverse event monitoring will take place throughout the 12-week study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provide voluntary signed and dated informed consent.
- •Be in good health as determined by medical history and routine blood chemistries.
- •Age between the ages of 18 and
- •Body Mass Index (BMI):
- •22-25; Waist:Hip Ratio 0.9-1
- •25-35; Waist:Hip Ratio 0.85-1
- •Normotensive (supine, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
- •Normal supine, resting heart rate (<90 per minute).
- •Willing to duplicate their previous 24-hour diet, and fast for 8-10 hours prior each of the treatments.
- •Has been participating in regular exercise training, at least 3 days per week, for the past 1-2 months.
排除标准
- •History of diabetes.
- •Use of any pre-workout or creatine containing products in the last 4 weeks.
- •History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- •Prior gastrointestinal bypass surgery (Lapband, etc.).
- •Other known gastrointestinal or metabolic diseases that might impact absorption or amino acid metabolism, e.g. short bowel syndrome, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
- •Chronic inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.). -Known sensitivity to any ingredient in the test formulations as listed in the Certificates- of-Analysis.
- •Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- •Concomitant use of corticosteroids or testosterone replacement therapy (ingestion, injection, or transdermal).
- •Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.
研究组 & 干预措施
Placebo
Placebo (microcrystalline cellulose)
干预措施: Placebo (Dietary Supplement)
Indus810
Indus810 ( 500mg/d)
干预措施: Indus810 (Dietary Supplement)
结局指标
主要结局
Body composition
时间窗: Change in score from Day 0 to day 56 and from day 0 to day 84
body fat percentage (%)
次要结局
- Upper body strength(Change in pounds from Day 0 to day 56 and from day 0 to day 84)
研究者
Jennifer Sandrock
Chief Operating Officer
The Center for Applied Health Sciences, LLC