Botanical Supplement Muscle Function and Lean Body Mass



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 35
Updated:9/20/2018
Start Date:November 2016
End Date:August 2018

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The Acute and Chronic Influence of a Botanical Supplement on 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.


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.
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