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Botanical Supplement Muscle Function and Lean Body Mass

NCT03034668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2018-09-18

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DIETARY_SUPPLEMENT

CS16-003 Full dose

350 mg 'Rhodiola rosea L. \& Rhaptonticum carthamoides extracts

DIETARY_SUPPLEMENT

CS16-003 Half dose

175 mg 'Rhodiola rosea L. \& Rhaptonticum carthamoides extracts + maltodextrin 175 mg

DIETARY_SUPPLEMENT

Placebo

Maltodextrin: 350 mg

Sponsors & Collaborators

  • Givaudan France Naturals

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Eric Ryan, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03034668 on ClinicalTrials.gov