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

NCT03850106 | Completed DMC

• 1 other identifier: INDUS-PC-BC-2018
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Conditions

Weakness, Muscle

Outcome Measures

Primary Outcomes (1)

• Body composition

  body fat percentage (%)

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

Secondary Outcomes (1)

• Upper body strength

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (microcrystalline cellulose)

Dietary Supplement: Placebo

Indus810

ACTIVE COMPARATOR

Indus810 ( 500mg/d)

Dietary Supplement: Indus810

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Indus810 DIETARY_SUPPLEMENT

Active product

Indus810

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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):
• ; Waist:Hip Ratio 0.9-1
• ; 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Center for Applied Health Sciences, LLC: lead
• Indus Biotech: collaborator

Study Sites (1)

The Center for Applied Health Sciences

Stow, Ohio, 44224, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Tim N Ziegenfuss, PhD

  The Center for Applied Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Operating Officer

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 21, 2019
• Study Start: July 11, 2018
• Primary Completion: March 15, 2019
• Study Completion: April 30, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

US (1)