Effects of INDUS810 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.

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.