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Completed

NCT Number: NCT03034668

Botanical Supplement 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina, Department of Exercise and Sport Science

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CS16-003 Full dose

Dietary Supplement

350 mg 'Rhodiola rosea L. & Rhaptonticum carthamoides extracts

CS16-003 Half dose

Dietary Supplement

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

Placebo

Dietary Supplement

Maltodextrin: 350 mg

Primary outcomes

  1. Maximal Isokinetic Leg Extension strength measured by dynamometry

    Time frame: Acute/Immediate

  2. Maximal Upper and Lower Body Strength measured by 1 repetition maximum

    Time frame: 8 weeks

Secondary outcomes

  1. Bench Press Repetitions to Fatigue

    Time frame: 8 weeks

  2. Leg Press Repetitions to Fatigue

    Time frame: 8 weeks

  3. Body Composition-Lean Mass

    Time frame: 8 weeks

  4. Body Composition-Fat Mass

    Time frame: 8 weeks

  5. Muscle cross sectional area

    Time frame: 8 weeks

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Givaudan France Naturals

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 27, 2017
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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