The Acute and Chronic Influence of a Botanical Supplement on Muscle Function and Lean Body Mass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Maximal Isokinetic Leg Extension strength measured by dynamometry
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
CS16-003 Full dose
350 mg capsule QD Rhodiola rosea L. & Rhaptonticum carthamoides extracts
干预措施: CS16-003 Full dose (Dietary Supplement)
CS16-003 Half dose
175 mg capsule QD 50% Rhodiola rosea L. & Rhaptonticum carthamoides extracts + 50% Maltodextrin
干预措施: CS16-003 Half dose (Dietary Supplement)
Placebo
Maltodextrin
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Maximal Isokinetic Leg Extension strength measured by dynamometry
时间窗: Acute/Immediate
Maximal Upper and Lower Body Strength measured by 1 repetition maximum
时间窗: 8 weeks
次要结局
- Muscle cross sectional area(8 weeks)
- Bench Press Repetitions to Fatigue(8 weeks)
- Body Composition-Fat Mass(8 weeks)
- Leg Press Repetitions to Fatigue(8 weeks)
- Body Composition-Lean Mass(8 weeks)
- Change in Quality of Life Score from baseline to 8 weeks(baseline, 8 weeks)
- Change in Mood score from baseline to 8 weeks(baseline; 8 weeks)
- Change in Felt Arousal score from baseline to 8 weeks(baseline, 8 weeks)