Botanical Supplement Muscle Function and Lean Body Mass
NCT ID: NCT03034668
Last Updated: 2018-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
119 participants
INTERVENTIONAL
2016-11-30
2018-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
TRIPLE
Study Groups
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CS16-003 Full dose
350 mg capsule QD Rhodiola rosea L. \& Rhaptonticum carthamoides extracts
CS16-003 Full dose
350 mg 'Rhodiola rosea L. \& Rhaptonticum carthamoides extracts
CS16-003 Half dose
175 mg capsule QD 50% Rhodiola rosea L. \& Rhaptonticum carthamoides extracts + 50% Maltodextrin
CS16-003 Half dose
175 mg 'Rhodiola rosea L. \& Rhaptonticum carthamoides extracts + maltodextrin 175 mg
Placebo
Maltodextrin
Placebo
Maltodextrin: 350 mg
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
35 Years
MALE
Yes
Sponsors
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Givaudan France Naturals
INDUSTRY
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Eric Ryan, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina, Department of Exercise and Sport Science
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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16-1991
Identifier Type: -
Identifier Source: org_study_id
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