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

Primary Purpose

Weakness, Muscle

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Placebo

Indus810

About this trial

This is an interventional treatment trial for Weakness, Muscle

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

The Center for Applied Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Indus810

Arm Description

Placebo (microcrystalline cellulose)

Indus810 ( 500mg/d)

Outcomes

Primary Outcome Measures

Body composition

body fat percentage (%)

Secondary Outcome Measures

Upper body strength

Weight lifted in pounds

Full Information

NCT ID

NCT03850106

First Posted

January 29, 2019

Last Updated

February 17, 2020

Sponsor

The Center for Applied Health Sciences, LLC

Collaborators

Indus Biotech

1. Study Identification

Unique Protocol Identification Number

NCT03850106

Brief Title

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

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

July 11, 2018 (Actual)

Primary Completion Date

March 15, 2019 (Actual)

Study Completion Date

April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Center for Applied Health Sciences, LLC

Collaborators

Indus Biotech

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weakness, Muscle

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (microcrystalline cellulose)

Arm Title

Indus810

Arm Type

Active Comparator

Arm Description

Indus810 ( 500mg/d)

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Indus810

Intervention Description

Active product

Primary Outcome Measure Information:

Title

Body composition

Description

body fat percentage (%)

Time Frame

Change in score from Day 0 to day 56 and from day 0 to day 84

Secondary Outcome Measure Information:

Title

Upper body strength

Description

Weight lifted in pounds

Time Frame

Change in pounds from Day 0 to day 56 and from day 0 to day 84

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tim N Ziegenfuss, PhD

Organizational Affiliation

The Center for Applied Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Center for Applied Health Sciences

City

Stow

State/Province

Ohio

ZIP/Postal Code

44224

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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