Botanical Supplement Muscle Function and Lean Body Mass

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034668
• Other study ID #: 16-1991
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• CS16-003 Full dose
350 mg 'Rhodiola rosea L. & Rhaptonticum carthamoides extracts
• CS16-003 Half dose
175 mg 'Rhodiola rosea L. & Rhaptonticum carthamoides extracts + maltodextrin 175 mg
• Placebo
Maltodextrin: 350 mg

Locations

Country	Name	City	State
United States	University of North Carolina, Department of Exercise and Sport Science	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Naturex SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Isokinetic Leg Extension strength measured by dynamometry		Acute/Immediate
Primary	Maximal Upper and Lower Body Strength measured by 1 repetition maximum		8 weeks
Secondary	Bench Press Repetitions to Fatigue		8 weeks
Secondary	Leg Press Repetitions to Fatigue		8 weeks
Secondary	Body Composition-Lean Mass		8 weeks
Secondary	Body Composition-Fat Mass		8 weeks
Secondary	Muscle cross sectional area		8 weeks
Secondary	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
Secondary	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
Secondary	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