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Botanical Supplement Muscle Function and Lean Body Mass

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ClinicalTrials.gov Identifier: NCT03034668
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Naturex SA
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Maltodextrin
Dietary Supplement: Placebo
Maltodextrin: 350 mg




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034668


Locations
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United States, North Carolina
University of North Carolina, Department of Exercise and Sport Science
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Naturex SA
Investigators
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Principal Investigator: Eric Ryan, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03034668     History of Changes
Other Study ID Numbers: 16-1991
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of North Carolina, Chapel Hill:
Botanical Supplement
Performance-Enhancing Supplement