Clinical trial NCT03850106: Effects of INDUS810 on Body Composition, Muscular Performance, and Training Adaptations
Official title: Effects of INDUS810 on Body Composition, Muscular Performance, and Training Adaptations During 12-weeks of Supplementation and Concurrent Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weakness, Muscle
Lead sponsor: The Center for Applied Health Sciences, LLC
Sponsor class: INDUSTRY
Collaborators: name: Indus Biotech
First posted: 2019-02-21
Enrollment: 67
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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):

  * 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Body composition
timeFrame: Change in score from Day 0 to day 56 and from day 0 to day 84
Secondary outcomes:
measure: Upper body strength
timeFrame: Change in pounds from Day 0 to day 56 and from day 0 to day 84
Other outcomes:
Locations:
city: Stow
country: United States
facility: The Center for Applied Health Sciences
state: Ohio
Study officials:
affiliation: The Center for Applied Health Sciences
name: Tim N Ziegenfuss, PhD
role: PRINCIPAL_INVESTIGATOR
References: