Effects of INDUS810 on Body Composition, Muscular Performance, and Training Adaptations

Weakness, Muscle Clinical Trial

Official title:

Effects of INDUS810 on Body Composition, Muscular Performance, and Training Adaptations During 12-weeks of Supplementation and Concurrent Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850106
• Other study ID #: INDUS-PC-BC-2018
• Status: Completed
• Phase: N/A
• Start date: July 11, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: February 2020
• Source: The Center for Applied Health Sciences, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 30, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness
• Weakness, Muscle

Intervention

Dietary Supplement:
• Placebo
Placebo
• Indus810
Active product

Locations

Country	Name	City	State
United States	The Center for Applied Health Sciences	Stow	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Center for Applied Health Sciences, LLC	Indus Biotech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	body fat percentage (%)	Change in score from Day 0 to day 56 and from day 0 to day 84
Secondary	Upper body strength	Weight lifted in pounds	Change in pounds from Day 0 to day 56 and from day 0 to day 84