Healthy Volunteers
Conditions
Keywords
Botanical Supplement, Performance-Enhancing Supplement
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.
Interventions
DIETARY_SUPPLEMENTCS16-003 Full dose
350 mg 'Rhodiola rosea L. & Rhaptonticum carthamoides extracts
DIETARY_SUPPLEMENTCS16-003 Half dose
175 mg 'Rhodiola rosea L. & Rhaptonticum carthamoides extracts + maltodextrin 175 mg
DIETARY_SUPPLEMENTPlacebo
Maltodextrin: 350 mg
Sponsors
Givaudan France Naturals
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal Isokinetic Leg Extension strength measured by dynamometry | Acute/Immediate |
| Maximal Upper and Lower Body Strength measured by 1 repetition maximum | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition-Lean Mass | 8 weeks | — |
| Body Composition-Fat Mass | 8 weeks | — |
| Muscle cross sectional area | 8 weeks | — |
| Bench Press Repetitions to Fatigue | 8 weeks | — |
| Change in Felt Arousal score from baseline to 8 weeks | baseline, 8 weeks | Felt arousal scale. Scores range 1-6 with 1 being low arousal and 6 being high. One score selected. |
| Change in Mood score from baseline to 8 weeks | baseline; 8 weeks | Mood determined from a VAS. 0-100, with 0 = not depressed at all and 100 = most depressed. |
| Change in Quality of Life Score from baseline to 8 weeks | 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. |
| Leg Press Repetitions to Fatigue | 8 weeks | — |
Countries
United States
Outcome results
None listed