Botanical Supplement Muscle Function and Lean Body Mass

University of North Carolina (UNC)

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Placebo; Dietary Supplement: CS16-003 Half dose; Dietary Supplement: CS16-003 Full dose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03034668

16-1991

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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119 participants in 3 patient groups, including a placebo group

CS16-003 Full dose

Experimental group

Description:

350 mg capsule QD Rhodiola rosea L. \& Rhaptonticum carthamoides extracts

Treatment:

Dietary Supplement: CS16-003 Full dose

CS16-003 Half dose

Experimental group

Description:

175 mg capsule QD 50% Rhodiola rosea L. \& Rhaptonticum carthamoides extracts + 50% Maltodextrin

Treatment:

Dietary Supplement: CS16-003 Half dose

Placebo

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: Placebo