Effects of Wild Ginseng Extract on Exercise Performance, Cognitive Function, and Fatigue Recovery Using College Students: a Randomized Cross-Over, Placebo-Controlled, and Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Peak and average power outputs (Watts/kg)
研究概览
简要总结
The goal of this clinical trial was to learn if Wild Ginseng extract (WG) influences exercise performance, cognitive function, and fatigue recovery from the exercise.
The main questions to answer were:
- Does WG improve exercise performance?
- Does WG improve cognitive function?
- Does WG facilitate recovery from the exercise?
The investigators will compare WG to a Placebo (a look-alike substance that contains no substance) to see if WG works.
Participants will:
- Take WG or a Placebo every day for 7 days with a 2-week wash-out (It is a specific time frame. During this time, certain substances are removed from the body).
- Visit the laboratory a total of five times for the tests, including one pre-familiarization (to be familiar with the exercise and other procedures)
详细描述
Dietary supplements are used by athletes worldwide. In the United States, the Dietary Supplement Health Education Act has defined dietary supplements as something added to the diet, mainly vitamins, minerals, protein, herbs or botanicals, and metabolites/constituents/extracts, or a combination of any of these ingredients. In the realm of sports performance enhancement, the quest for safe and effective ergogenic aids continues to evolve. With the evolving landscape of supplementation, a significant portion of the Americans tends to favor very specific supplements.
Among the plethora of natural substances garnering attention, wild ginseng extract emerges as a compelling candidate. Ginseng is widely used for its promising healing and restorative properties as well as for its possible tonic effect in traditional medicine and has recently become a popular supplement in Western Countries. There are a multitude of variations among ginseng: among those, Korean ginseng is most notable for its efficacy. To date there have been numerous studies utilizing Korean ginseng attempting to establish an increase in either sports performance, cognitive function, or fatigue recovery. The use of ginseng thus far has not proved much success in the realm of performance enhancement. Conversely, notable achievements have been observed in the realms of cognitive enhancement and fatigue mitigation. The wild ginseng extract has exhibited promising results in ameliorating psychomotor performance and mitigating the effects of chronic fatigue associated with various pathological conditions.
Some issues arise from previous studies of ginseng use as an ergonomic aid. First are the inadequate sample sizes that are being utilized. Secondly are the varying dosages that are being used throughout the study. The issues that arise with all previous studies are the varying doses along with inadequate sample sizes. The limitations of previous investigations lie predominantly in their emphasis on chronic effects, or their exclusive focus on specific domains such as endurance sports and cognitive function. Consequently, there remains a notable scarcity of research delving into the acute impacts of wild ginseng extract on exercise performance, cognitive function, and fatigue recovery. Therefore, the primary objective of this study was to elucidate the effects of wild ginseng extract on exercise performance, cognitive function, and fatigue recovery.
This study is a double-blind, placebo-controlled crossover experiment with two trials (WG and placebo). Twelve healthy adult males (age=31±6.86 years) were randomly assigned to either WG or placebo groups with 2-week wash-out period. After a brief explanation of procedures, exercises, risks, and benefits associated with the study, each participant gave written consent before participation. The study was approved by the College's Institutional Review Board. Participants completed a questionnaire before the initiation of the experiment. Any of the participants who had any health issues, injuries, metabolic, cardiovascular, pulmonary disease, or intake of medication and or herbal supplementation were excluded from the trials.
Before the test, The investigators had a pre-familiarization that was conducted 3-5 days prior to the experiment. During the pre-familiarization, The investigators conducted a VO2 max test, body composition measurements, and cognitive function test. Body Composition. Body weight, height, percentage of body fat, blood pressure (mmHg), and heart rate (beats/min) were assessed. Body weight and height (weight in kilograms, height in meters) were measured using a wall stadiometer (PAT #290237, Novel Products, USA). Body fat (kg) was measured by skin fold (PAT#3,008,239, Beta Technology, USA). Blood pressure (mmHg) was measured using a blood pressure gauge (BP791IT, Omron, Japan). Heart rate (beats/min) was assessed by using a heart rate monitor (S120, Polar, USA). After the pre-familiarization, the experiments began. A Korean wild ginseng extract drink or placebo was given 90 minutes before the cycling exercise began. Power, strength, and cognitive function tests were conducted before, during, and after the experiment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind study using identical-looking package. The taste of the beverage was very similar for both WG and placebo (based on food survey)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects (age from 18-30 years old) that have no health problems, injuries, metabolic, cardiovascular, or pulmonary disease.
- •No history of taking prescription medications or herbals
排除标准
- •Having health problems, injuries, metabolic, cardiovascular, or pulmonary disease.
结局指标
主要结局
Peak and average power outputs (Watts/kg)
时间窗: through study completion, an average of 3 months
The participants performed a 2-minute warm-up by cycling at 100 to 120 revolutions per minute with a power of 100 to 120 Watts using an automatic Powercycle (Powercycle, USA). They performed four bouts of maximal acceleration for approximately 3 to 4 seconds on a verbal command with standardized encouragement. Data was recorded for 6.5 crank revolutions. The length of seat height was selected by each subject.
Strength (kg)
时间窗: through study completion, an average of 3 months
Isometric knee extensor and flexor strength were measured by a muscle testing system (Lafayette, USA). The participants sat on the table in supine position, and the knee and hip are positioned 90 degrees. The participants were instructed to remain seated and place both hands on the table. The dynamometer force pad was placed proximal to the ankle joint, and the knee extensor strength was quantified in pound force. All participants performed two maximal trials for 3 to 5 seconds with a 30-second rest interval. The higher value of the two trials was recorded.
Endurance (time: minutes and seconds)
时间窗: through study completion, an average of 3 months
The participants performed the 10-mile time trial to assess endurance performance (second) using a cycle ergometer. The cycle ergometer (984E, Monark, Sweden) was used to perform the time trial cycling. The workload was standardized for each subject by setting the resistance to achieve 70% VO2 max (maximal oxygen consumption measured during 1st lab visit). Subjects received standard encouragement to complete the time trial as quickly as possible and the time (minute and second) to complete the 10-mile distance was recorded.
Cognitive function (psychomotor vigilance task (PVT): msec)
时间窗: through study completion, an average of 3 months
The PVT test is composed of 40 trials for 5 minutes to assess mean reaction time (msec). Participants were instructed to attend to a small, fix point at the center of a computer screen for 2 s (sec) and then respond via button press as rapidly as possible between 100 milliseconds (msec) and 500 msec upon detection of a msec counter on the screen. The stimulus was presented at random time intervals between 2 and 10 s. The final counter values corresponded to the participant's reaction time. Response success (within a range of 100-500 msec) or failure (\< 100 msec or\> 500 msec) was displayed on the window screen for 1 s, thus providing feedback for reaction time (msec) and data were stored on the computer as average reaction time (msec) and the number of correct trials. PVT took approximately 5 min and consisted of 45 trials.
Cognitive function (match-to-sample memory task (DMS): msec and number of correct trials)
时间窗: through study completion, an average of 3 months
With an initial key press, participants viewed and studied a 5× 5 grid of brightly colored yellow and red squares with a unique pattern on a computer screen. After another key press, the stimulus disappeared, and the screen became blank through a 6 s-delay period, and then two stimuli were presented on the screen (a "match" and "non-match"). Participants were asked to indicate which stimulus was the correct "match" with a key press and to respond as quickly and as accurately as possible, thus providing feedback for either "correct" or "incorrect" trial in 1 s. After completing 30 trials for 5-6 min, the final counter values were stored on the computer as average study time (msec), memory retrieval latency (msec), and the number of correct trials.
Fatigue recovery (scale (6-20) and fatigue questionnaire)
时间窗: through study completion, an average of 3 months
Fatigue recovery rates were measured utilizing a rate of perceived exertion (RPE), a scale of muscle soreness, and a fatigue questionnaire that was provided. The Borg RPE scale rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). A rating between 12 to 14 typically reflects a moderate or somewhat hard level of intensity.
次要结局
- Maximal aerobic capacity (VO2 max) (ml/kg/min)(One day: one time at the beginning of the study (1st visit).)
- Height (cm)(One day: one time at the beginning of the study (1st visit).)
- Body weight (kg and lb)(One day: one time at the beginning of the study (1st visit).)
- Heart rate (beats per mins (BPM))(One day: one time at the beginning of the study (1st visit).)
- Body fat (%)(One day: one time at the beginning of the study (1st visit).)
- Blood pressure (mmHg)(One day: one time at the beginning of the study (1st visit).)
- Blood Analysis (Glucose (mg/dL))(Two days (two separate visits). Total 7 time points (0, 100, 140, right after time trial, 30, 60, and 120 mins after time trial test) mins) during the each trail. 7 time points x 2 trials = 14 times.)
- Blood Analysis (Interleukin-6 (IL-6: pg/mL))(Two days (two separate visits). Total 7 time points (0, 100, 140, right after time trial, 30, 60, and 120 mins after time trial test) mins) during the each trail. 7 time points x 2 trials = 14 times.)
- Blood Analysis (Myoglobin (mcg/L))(Two days (two separate visits). Total 7 time points (0, 100, 140, right after time trial, 30, 60, and 120 mins after time trial test) mins) during the each trail. 7 time points x 2 trials = 14 times.)
- Blood Analysis (Total antioxidant capacity (TAC): nM)(Two days (two separate visits). Total 7 time points (0, 100, 140, right after time trial, 30, 60, and 120 mins after time trial test) mins) during the each trail. 7 time points x 2 trials = 14 times.)
- Blood Analysis (Cortisol (ng/ml))(Two days (two separate visits). Total 7 time points (0, 100, 140, right after time trial, 30, 60, and 120 mins after time trial test) mins) during the each trail. 7 time points x 2 trials = 14 times.)
研究者
Dr. Suk H. Lee
Professor of Health and KInesiology
Texas A&M University San Antonio