Botanical Supplement Muscle Function and Lean Body Mass

NCT03034668 | Completed

• 1 other identifier: 16-1991
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Botanical Supplement; Performance-Enhancing Supplement

Outcome Measures

Primary Outcomes (2)

• Maximal Isokinetic Leg Extension strength measured by dynamometry

  Acute/Immediate

• Maximal Upper and Lower Body Strength measured by 1 repetition maximum

  8 weeks

Secondary Outcomes (8)

• 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

Study Arms (3)

CS16-003 Full dose

EXPERIMENTAL

350 mg capsule QD Rhodiola rosea L. \& Rhaptonticum carthamoides extracts

Dietary Supplement: CS16-003 Full dose

CS16-003 Half dose

EXPERIMENTAL

175 mg capsule QD 50% Rhodiola rosea L. \& Rhaptonticum carthamoides extracts + 50% Maltodextrin

Dietary Supplement: CS16-003 Half dose

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

CS16-003 Full dose DIETARY_SUPPLEMENT

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

CS16-003 Full dose

CS16-003 Half dose DIETARY_SUPPLEMENT

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

CS16-003 Half dose

Placebo DIETARY_SUPPLEMENT

Maltodextrin: 350 mg

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Givaudan France Naturals: collaborator

Study Sites (1)

University of North Carolina, Department of Exercise and Sport Science

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Eric Ryan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 27, 2017
• Study Start: November 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)