Ignite Creation Date:
2024-05-06 @ 12:48 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03850106
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2019-01-29
Brief Title:
Effects of INDUS810 on Body Composition Muscular Performance and Training Adaptations
Sponsor:
The Center for Applied Health Sciences LLC
Organization:
The Center for Applied Health Sciences LLC
Study Overview
Official Title:
Effects of INDUS810 on Body Composition Muscular Performance and Training Adaptations During 12-weeks of Supplementation and Concurrent Training
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N66 recreationally but normal to moderately overweightobese male subjects to be recruited at a single investigational center in Northeast Ohio ie The Center for Applied Health Sciences
Subjects will attend 4 study visits At Visit 1 subjects will be screened for participation ie 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
Subjects will attend 4 study visits At Visit 1 subjects will be screened for participation ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None