Botanical Supplement Muscle Function and Lean Body Mass
|ClinicalTrials.gov Identifier: NCT03034668|
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : September 18, 2018
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Dietary Supplement: CS16-003 Full dose Dietary Supplement: CS16-003 Half dose Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Acute and Chronic Influence of a Botanical Supplement on Muscle Function and Lean Body Mass|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
Experimental: CS16-003 Full dose
350 mg capsule QD Rhodiola rosea L. & Rhaptonticum carthamoides extracts
Dietary Supplement: CS16-003 Full dose
350 mg 'Rhodiola rosea L. & Rhaptonticum carthamoides extracts
Experimental: CS16-003 Half dose
175 mg capsule QD 50% Rhodiola rosea L. & Rhaptonticum carthamoides extracts + 50% Maltodextrin
Dietary Supplement: CS16-003 Half dose
175 mg 'Rhodiola rosea L. & Rhaptonticum carthamoides extracts + maltodextrin 175 mg
Placebo Comparator: Placebo
Dietary Supplement: Placebo
Maltodextrin: 350 mg
- Maximal Isokinetic Leg Extension strength measured by dynamometry [ Time Frame: Acute/Immediate ]
- Maximal Upper and Lower Body Strength measured by 1 repetition maximum [ Time Frame: 8 weeks ]
- Bench Press Repetitions to Fatigue [ Time Frame: 8 weeks ]
- Leg Press Repetitions to Fatigue [ Time Frame: 8 weeks ]
- Body Composition-Lean Mass [ Time Frame: 8 weeks ]
- Body Composition-Fat Mass [ Time Frame: 8 weeks ]
- Muscle cross sectional area [ Time Frame: 8 weeks ]
- Change in Quality of Life Score from baseline to 8 weeks [ Time Frame: baseline, 8 weeks ]Quality of life from a visual analog scale (VAS) 0-100, with 0 = worst quality of life and 100=best quality of life.
- Change in Felt Arousal score from baseline to 8 weeks [ Time Frame: baseline, 8 weeks ]Felt arousal scale. Scores range 1-6 with 1 being low arousal and 6 being high. One score selected.
- Change in Mood score from baseline to 8 weeks [ Time Frame: baseline; 8 weeks ]Mood determined from a VAS. 0-100, with 0 = not depressed at all and 100 = most depressed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034668
|United States, North Carolina|
|University of North Carolina, Department of Exercise and Sport Science|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Eric Ryan, PhD||University of North Carolina, Chapel Hill|