Botanical Supplement Muscle Function and Lean Body Mass

The Acute and Chronic Influence of a Botanical Supplement on Muscle Function and Lean Body Mass

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: CS16-003 Full dose; Dietary supplement: CS16-003 Half dose; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina, Department of Exercise and Sport Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Recreationally Active (1- 4 hours of exercise/ sports participation per week and no more than 1 hour of resistance training exercise per week) for the previous 12 weeks.
• BMI < 30 kg/m²
• Have not smoked in the past year.
• Participant has provided written and dated informed consent to participate in the study
• Participant is willing and able to comply with the protocol
• Participant is apparently healthy and free from disease, as determined by a health history questionnaire
• Participant agrees to abstain from caffeine, tobacco, alcohol, and exercise within 24 hours of testing visits

Exclusion Criteria:

• Participant has not used any dietary supplements within 12 weeks prior to enrollment and will not begin supplementation during the study. Potential supplements include but are not limited to Beta-alanine, Creatine, HMB, Carnosine, Taurine, androstenedione, DHEA, Whey protein, or a pre-workout supplement.
• Participant has gained or lost 10 lbs in the previous 2 months.
• Participant is currently enrolled in a separate clinical trial.
• Participant has participated in a clinical trial within the previous 2 months that includes modifications to their physical and/or diet.
• Participant has a known allergy or sensitivity to the placebo (maltodextrin) or active ingredients (Rhodiola & Rhaptonicum)
• Participant consumes more than 8 cups (1 cup = 6 oz) of coffee per day on a regular basis
• Participant consumes more than 3 alcoholic drinks per day.
• Participant uses recreational drugs daily.
• Previous physical symptoms causing a physician to recommend you to refrain from exercise.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin	Dietary supplement: Placebo; Maltodextrin: 350 mg
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximal Isokinetic Leg Extension strength measured by dynamometry	Acute/Immediate
Maximal Upper and Lower Body Strength measured by 1 repetition maximum	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bench Press Repetitions to Fatigue		8 weeks
Leg Press Repetitions to Fatigue		8 weeks
Body Composition-Lean Mass		8 weeks
Body Composition-Fat Mass		8 weeks
Muscle cross sectional area		8 weeks
Change in Quality of Life Score from baseline to 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.	baseline, 8 weeks
Change in Felt Arousal score from baseline to 8 weeks	Felt arousal scale. Scores range 1-6 with 1 being low arousal and 6 being high. One score selected.	baseline, 8 weeks
Change in Mood score from baseline to 8 weeks	Mood determined from a VAS. 0-100, with 0 = not depressed at all and 100 = most depressed.	baseline; 8 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Naturex SA
• Investigators: Principal Investigator: Eric Ryan, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Botanical Supplement; Performance-Enhancing Supplement
• Other Study ID Numbers: 16-1991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO