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| Name | Class |
|---|---|
| Indus Biotech | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (microcrystalline cellulose) |
|
| Indus810 | Active Comparator | Indus810 ( 500mg/d) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo |
| |
| Indus810 |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | body fat percentage (%) | Change in score from Day 0 to day 56 and from day 0 to day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Upper body strength | Weight lifted in pounds | Change in pounds from Day 0 to day 56 and from day 0 to day 84 |
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Inclusion Criteria:
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 45.
Body Mass Index (BMI):
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim N Ziegenfuss, PhD | The Center for Applied Health Sciences, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Applied Health Sciences | Stow | Ohio | 44224 | United States |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| Dietary Supplement |
Active product |
|
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |