Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-06 @ 5:44 PM
Study NCT ID:
NCT03034668
Status:
COMPLETED
Last Update Posted:
2018-09-18
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botanical Supplement Muscle Function and Lean Body Mass
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
The Acute and Chronic Influence of a Botanical Supplement on Muscle Function and Lean Body Mass
Status:
COMPLETED
Status Verified Date:
2018-09
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:
Purpose: To evaluate the acute and chronic effects of a botanical supplement on strength, muscle function, and lean body mass
Participants: The acute phase will include 30 participants, and the chronic phase will include 84 participants. All participants must be healthy recreationally active males between the ages of 18 and 35 years.
Procedures (methods):
Acute phase: Participants will complete three testing visits as part of as part of a cross-over design, during which strength and muscle function will be assessed prior to and following consumption of a supplement. The experimental supplement is a blend of the botanical extracts; treatment arms will include a full dose (FULL; 350 mg capsule), half dose (HALF; 175 mg plus maltodextrin), or placebo (PLA; maltodextrin).
Chronic phase: Body composition, muscle cross-sectional area, a complete blood count and metabolic panel, subjective surveys, and strength will be measured prior to and following an 8-week supervised resistance training program, in conjunction with daily supplementation of FULL, HALF, or PLA.
Participants: The acute phase will include 30 participants, and the chronic phase will include 84 participants. All participants must be healthy recreationally active males between the ages of 18 and 35 years.
Procedures (methods):
Acute phase: Participants will complete three testing visits as part of as part of a cross-over design, during which strength and muscle function will be assessed prior to and following consumption of a supplement. The experimental supplement is a blend of the botanical extracts; treatment arms will include a full dose (FULL; 350 mg capsule), half dose (HALF; 175 mg plus maltodextrin), or placebo (PLA; maltodextrin).
Chronic phase: Body composition, muscle cross-sectional area, a complete blood count and metabolic panel, subjective surveys, and strength will be measured prior to and following an 8-week supervised resistance training program, in conjunction with daily supplementation of FULL, HALF, or PLA.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: