Clinical trial NCT03034668: Botanical Supplement Muscle Function and Lean Body Mass
Official title: The Acute and Chronic Influence of a Botanical Supplement on Muscle Function and Lean Body Mass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Botanical Supplement
Performance-Enhancing Supplement
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Givaudan France Naturals
First posted: 2017-01-27
Enrollment: 119
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Maximal Isokinetic Leg Extension strength measured by dynamometry
timeFrame: Acute/Immediate
measure: Maximal Upper and Lower Body Strength measured by 1 repetition maximum
timeFrame: 8 weeks
Secondary outcomes:
measure: Bench Press Repetitions to Fatigue
timeFrame: 8 weeks
measure: Leg Press Repetitions to Fatigue
timeFrame: 8 weeks
measure: Body Composition-Lean Mass
timeFrame: 8 weeks
measure: Body Composition-Fat Mass
timeFrame: 8 weeks
measure: Muscle cross sectional area
timeFrame: 8 weeks
measure: Change in Quality of Life Score from baseline to 8 weeks
timeFrame: baseline, 8 weeks
measure: Change in Felt Arousal score from baseline to 8 weeks
timeFrame: baseline, 8 weeks
measure: Change in Mood score from baseline to 8 weeks
timeFrame: baseline; 8 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Department of Exercise and Sport Science
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Eric Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: