The Investigators Conducted a Study to Examine the Impact of Wild Ginseng Extract (WG) on Exercise Performance, Cognitive Function, and Fatigue Recovery Among Twelve Healthy Adult Males

NCT06679725 | Completed

• 2 other identifiers: Wild Ginseng Extract11072014
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Healthy

Keywords

Ginseng; Exercise

Outcome Measures

Primary Outcomes (6)

• Peak and average power outputs (Watts/kg)

  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.

  through study completion, an average of 3 months

• Strength (kg)

  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.

  through study completion, an average of 3 months

• Endurance (time: minutes and seconds)

  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.

  through study completion, an average of 3 months

• Cognitive function (psychomotor vigilance task (PVT): msec)

  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.

  through study completion, an average of 3 months

• Cognitive function (match-to-sample memory task (DMS): msec and number of correct trials)

  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.

  through study completion, an average of 3 months

• Fatigue recovery (scale (6-20) and fatigue questionnaire)

  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.

  through study completion, an average of 3 months

Secondary Outcomes (11)

• 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).

Study Arms (2)

Wild ginseng extract

EXPERIMENTAL

The ginseng used in this study is a commercially manufactured standardized 140 ml liquid package and approved for safety. The drink contains 0.25% of wild ginseng extract and other ingredients while the placebo is manufactured to be identical in appearance (brown color, calorie (30.23 Kcal), taste, and content). The placebo utilized in the study consisted of the same ingredients as the treatment drink, with the exception of 0.25% wild ginseng extract.

Dietary Supplement: Wild ginseng extract

Placebo

PLACEBO COMPARATOR

The placebo utilized in the study consisted of the same ingredients as the treatment drink, with the exception of 0.25% Korean wild Ginseng Extract. This was achieved by incor-porating 0.25% scented ginseng and 0.06% caramel coloring (Table 1).

Dietary Supplement: Placebo

Interventions

Wild ginseng extract DIETARY_SUPPLEMENT

This ginseng extract was manufactured and provided by the Korea Food Research Institute (sponsor). It is extracted from red ginseng. Red ginseng is generally considered to have greater biological effects and fewer side effects than white or fresh ginseng.

Also known as: Ginseng extract

Wild ginseng extract

Placebo DIETARY_SUPPLEMENT

The placebo utilized in the study consisted of the same ingredients as the treatment drink, with the exception of 0.25% Korean wild Ginseng Extract. This was achieved by incor-porating 0.25% scented ginseng and 0.06% caramel coloring

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Having health problems, injuries, metabolic, cardiovascular, or pulmonary disease.

Sponsors & Collaborators

• Texas A&M University San Antonio: lead

Study Sites (1)

Texas A&M University-San Antonio

San Antonio, Texas, 78224, United States

Location

Related Publications (12)

• Zhu J, Xu X, Zhang X, Zhuo Y, Chen S, Zhong C, Liu M, Wang Z. Efficacy of ginseng supplements on disease-related fatigue: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Jul 1;101(26):e29767. doi: 10.1097/MD.0000000000029767.

  PMID: 35776997 BACKGROUND

• Bentler SE, Hartz AJ, Kuhn EM. Prospective observational study of treatments for unexplained chronic fatigue. J Clin Psychiatry. 2005 May;66(5):625-32. doi: 10.4088/jcp.v66n0513.

  PMID: 15889950 BACKGROUND

• Kennedy DO, Scholey AB, Wesnes KA. Dose dependent changes in cognitive performance and mood following acute administration of Ginseng to healthy young volunteers. Nutr Neurosci. 2001;4(4):295-310. doi: 10.1080/1028415x.2001.11747370.

  PMID: 11842896 BACKGROUND

• Scholey AB, Kennedy DO. Acute, dose-dependent cognitive effects of Ginkgo biloba, Panax ginseng and their combination in healthy young volunteers: differential interactions with cognitive demand. Hum Psychopharmacol. 2002 Jan;17(1):35-44. doi: 10.1002/hup.352.

  PMID: 12404705 BACKGROUND

• Fekete M, Lehoczki A, Tarantini S, Fazekas-Pongor V, Csipo T, Csizmadia Z, Varga JT. Improving Cognitive Function with Nutritional Supplements in Aging: A Comprehensive Narrative Review of Clinical Studies Investigating the Effects of Vitamins, Minerals, Antioxidants, and Other Dietary Supplements. Nutrients. 2023 Dec 15;15(24):5116. doi: 10.3390/nu15245116.

  PMID: 38140375 BACKGROUND

• Ping FW, Keong CC, Bandyopadhyay A. Effects of acute supplementation of Panax ginseng on endurance running in a hot & humid environment. Indian J Med Res. 2011 Jan;133(1):96-102.

  PMID: 21321426 BACKGROUND

• Morris AC, Jacobs I, McLellan TM, Klugerman A, Wang LC, Zamecnik J. No ergogenic effect of ginseng ingestion. Int J Sport Nutr. 1996 Sep;6(3):263-71. doi: 10.1123/ijsn.6.3.263.

  PMID: 8876346 BACKGROUND

• Engels HJ, Wirth JC. No ergogenic effects of ginseng (Panax ginseng C.A. Meyer) during graded maximal aerobic exercise. J Am Diet Assoc. 1997 Oct;97(10):1110-5. doi: 10.1016/S0002-8223(97)00271-X.

  PMID: 9336557 BACKGROUND

• Allen JD, McLung J, Nelson AG, Welsch M. Ginseng supplementation does not enhance healthy young adults' peak aerobic exercise performance. J Am Coll Nutr. 1998 Oct;17(5):462-6. doi: 10.1080/07315724.1998.10718795.

  PMID: 9791844 BACKGROUND

• Hsu CC, Ho MC, Lin LC, Su B, Hsu MC. American ginseng supplementation attenuates creatine kinase level induced by submaximal exercise in human beings. World J Gastroenterol. 2005 Sep 14;11(34):5327-31. doi: 10.3748/wjg.v11.i34.5327.

  PMID: 16149140 BACKGROUND

• Kulaputana O, Thanakomsirichot S, Anomasiri W. Ginseng supplementation does not change lactate threshold and physical performances in physically active Thai men. J Med Assoc Thai. 2007 Jun;90(6):1172-9.

  PMID: 17624213 BACKGROUND

• Reay JL, Kennedy DO, Scholey AB. The glycaemic effects of single doses of Panax ginseng in young healthy volunteers. Br J Nutr. 2006 Oct;96(4):639-42.

  PMID: 17010221 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind study using identical-looking package. The taste of the beverage was very similar for both WG and placebo (based on food survey)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health and KInesiology

Model Details: This study is a double-blind, placebo-controlled crossover experiment with two trials (WG and placebo) separated with 2-week wash-out period.

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: November 7, 2024
• Study Start: June 6, 2016
• Primary Completion: November 18, 2016
• Study Completion: May 12, 2017
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)