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Trial record 18 of 21 for:    fenugreek

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03850106
Recruitment Status : Active, not recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Indus Biotech
Information provided by (Responsible Party):
Jennifer Sandrock, The Center for Applied Health Sciences, LLC

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

Condition or disease Intervention/treatment Phase
Weakness, Muscle Dietary Supplement: Placebo Dietary Supplement: Indus810 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of INDUS810 on Body Composition, Muscular Performance, and Training Adaptations During 12-weeks of Supplementation and Concurrent Training
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo (microcrystalline cellulose)
Dietary Supplement: Placebo
Placebo

Active Comparator: Indus810
Indus810 ( 500mg/d)
Dietary Supplement: Indus810
Active product




Primary Outcome Measures :
  1. Body composition [ Time Frame: Change in score from Day 0 to day 56 and from day 0 to day 84 ]
    body fat percentage (%)


Secondary Outcome Measures :
  1. Upper body strength [ Time Frame: Change in pounds from Day 0 to day 56 and from day 0 to day 84 ]
    Weight lifted in pounds



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850106


Locations
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United States, Ohio
The Center for Applied Health Sciences
Stow, Ohio, United States, 44224
Sponsors and Collaborators
The Center for Applied Health Sciences, LLC
Indus Biotech
Investigators
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Principal Investigator: Tim N Ziegenfuss, PhD The Center for Applied Health Sciences

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Responsible Party: Jennifer Sandrock, Chief Operating Officer, The Center for Applied Health Sciences, LLC
ClinicalTrials.gov Identifier: NCT03850106     History of Changes
Other Study ID Numbers: INDUS-PC-BC-2018
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms