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出境医 / 临床实验 / Effects of Herbal Supplements on Endurance Exercise Performance

Effects of Herbal Supplements on Endurance Exercise Performance

Study Description
Brief Summary:
Cordyceps and Rhodiola are two common herbal supplements marketed and consumed as adaptogens to athletes with regard to enhanced performance. The effects of these supplements has been well studied in animals but whether or not the same effects translate to humans is still unclear. Thus, the primary purpose of this study is to determine whether combined supplementation of Rhodiola and Cordyceps, compared to Rhodiola alone and placebo, will demonstrate a greater improvement in oxygen consumption (ie. VO2 max).

Condition or disease Intervention/treatment Phase
Exercise Performance Dietary Supplement: Placebo of calcium Dietary Supplement: Rhodiola Dietary Supplement: Rhodiola and Cordyceps Not Applicable

Detailed Description:
Herbal supplements are consumed worldwide with surveys approximating five billion dollars spent annually by consumers in the United States alone. Herbal supplements, such as Rhodiola and Cordyceps, both of which are considered to be adaptogens, remain popular among athletes. These adaptogens act as antioxidants, which have been speculated to confer endurance performance benefits by delaying muscle fatigue via the attenuation of muscle damage accumulation and its related by-products during prolonged or exhaustive exercise. Nevertheless, previous research investigating the individual effects of Rhodiola and Cordyceps on aerobic training performance remain equivocal. Moreover, literature elucidating the potential additive effects of Rhodiola and Cordyceps in human subjects are scarce. Therefore, the purpose of the present study is to determine the acute, additive influence of oral Rhodiola and Cordyceps supplementation on VO2 max, with secondary variables of interest being plasma glucose and lactate concentration, and measures of gastrointestinal distress.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Blocked-randomized, crossover design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Herbal Supplements on Endurance Exercise Performance
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Placebo of calcium
Participants will consume 250 mg of calcium
 Dietary Supplement: Placebo of calcium
Ingestion of 250 mg of calcium
Experimental: Rhodiola
Participants will consume 250 mg of Rhodiola
 Dietary Supplement: Rhodiola
Ingestion of 250 mg of Rhodiola
Experimental: Rhodiola and Cordyceps
Participants will consume a combination of 250 mg of Rhodiola and 225 mg of Cordyceps
 Dietary Supplement: Rhodiola and Cordyceps
Ingestion of 250 mg of Rhodiola and 225 mg of Cordyceps
Outcome Measures
Primary Outcome Measures :
  1. VO2 max [ Time Frame: 90 minutes after baseline ]
    Maximum oxygen consumption using the Bruce Protocol


Secondary Outcome Measures :
  1. Gastrointestinal symptoms questionnaire [ Time Frame: Baseline, 90 minutes, 110 minutes ]
    Section 1 contains 6 questions assessing upper abdominal problems (reflux, heartburn, bloating, cramps, vomiting, and nausea). Section 2 contains 7 questions assessing lower abdominal problems (intestinal cramps, flatulence, urge to defecate, left abdominal pain, right abdominal pain, loose stool, and diarrhea). Section 3 contains 4 questions assessing systematic problems (dizziness, headache, muscle cramp, and urge to urinate). Each of the 17 questions is answered using a 10-point scale ranging from 0 (no problem at all) to 10 (the worst it has ever been). Each of the 3 sections will be scored separately. Section 1 will be scored on a scale of 0-60. Section 2 will be scored on a scale of 0-70. Section 3 will be scored on a scale of 0-40.

  2. Blood glucose [ Time Frame: Baseline, 90 minutes, 110 minutes ]
    Plasma glucose assessed by finger stick

  3. Blood lactate [ Time Frame: Baseline, 90 minutes, 110 minutes ]
    Plasma lactate assessed by finger stick


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index between 18.5 and 35 kg/m^2
  • Non-smoking (assessed by Health History Questionnaire)
  • English-speaking
  • Regular participation in physical activity (>4 hours per week)

Exclusion Criteria:

  • Medical conditions that prohibit physical activity (assessed by Health History Questionnaire)
  • Pregnant women or women expecting/trying to become pregnant
  • BMI greater than or equal to 35 kg/m^2
  • Current smoker (assessed by Health History Questionnaire)
Contacts and Locations

Locations
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United States, California
California Polytechnic State University
San Luis Obispo, California, United States, 93407
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
Investigators
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Principal Investigator: Todd Hagobian, PhD California Polytechnic State University-San Luis Obispo
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE May 1, 2019
Actual Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019) 		VO2 max [ Time Frame: 90 minutes after baseline ]
Maximum oxygen consumption using the Bruce Protocol
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Gastrointestinal symptoms questionnaire [ Time Frame: Baseline, 90 minutes, 110 minutes ]
    Section 1 contains 6 questions assessing upper abdominal problems (reflux, heartburn, bloating, cramps, vomiting, and nausea). Section 2 contains 7 questions assessing lower abdominal problems (intestinal cramps, flatulence, urge to defecate, left abdominal pain, right abdominal pain, loose stool, and diarrhea). Section 3 contains 4 questions assessing systematic problems (dizziness, headache, muscle cramp, and urge to urinate). Each of the 17 questions is answered using a 10-point scale ranging from 0 (no problem at all) to 10 (the worst it has ever been). Each of the 3 sections will be scored separately. Section 1 will be scored on a scale of 0-60. Section 2 will be scored on a scale of 0-70. Section 3 will be scored on a scale of 0-40.
  • Blood glucose [ Time Frame: Baseline, 90 minutes, 110 minutes ]
    Plasma glucose assessed by finger stick
  • Blood lactate [ Time Frame: Baseline, 90 minutes, 110 minutes ]
    Plasma lactate assessed by finger stick
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Gastrointestinal distress score [ Time Frame: Baseline, 90 minutes, 110 minutes ]
    17 question gastrointestinal distress questionnaire used to assess upper abdominal, lower abdominal, and systematic problems such as vomiting, abdominal pain, and headaches
  • Blood glucose [ Time Frame: Baseline, 90 minutes, 110 minutes ]
    Plasma glucose assessed by finger stick
  • Blood lactate [ Time Frame: Baseline, 90 minutes, 110 minutes ]
    Plasma lactate assessed by finger stick
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Herbal Supplements on Endurance Exercise Performance
Official Title  ICMJE Effects of Herbal Supplements on Endurance Exercise Performance
Brief Summary Cordyceps and Rhodiola are two common herbal supplements marketed and consumed as adaptogens to athletes with regard to enhanced performance. The effects of these supplements has been well studied in animals but whether or not the same effects translate to humans is still unclear. Thus, the primary purpose of this study is to determine whether combined supplementation of Rhodiola and Cordyceps, compared to Rhodiola alone and placebo, will demonstrate a greater improvement in oxygen consumption (ie. VO2 max).
Detailed Description Herbal supplements are consumed worldwide with surveys approximating five billion dollars spent annually by consumers in the United States alone. Herbal supplements, such as Rhodiola and Cordyceps, both of which are considered to be adaptogens, remain popular among athletes. These adaptogens act as antioxidants, which have been speculated to confer endurance performance benefits by delaying muscle fatigue via the attenuation of muscle damage accumulation and its related by-products during prolonged or exhaustive exercise. Nevertheless, previous research investigating the individual effects of Rhodiola and Cordyceps on aerobic training performance remain equivocal. Moreover, literature elucidating the potential additive effects of Rhodiola and Cordyceps in human subjects are scarce. Therefore, the purpose of the present study is to determine the acute, additive influence of oral Rhodiola and Cordyceps supplementation on VO2 max, with secondary variables of interest being plasma glucose and lactate concentration, and measures of gastrointestinal distress.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Blocked-randomized, crossover design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Exercise Performance
Intervention  ICMJE
  • Dietary Supplement: Placebo of calcium
    Ingestion of 250 mg of calcium
  • Dietary Supplement: Rhodiola
    Ingestion of 250 mg of Rhodiola
  • Dietary Supplement: Rhodiola and Cordyceps
    Ingestion of 250 mg of Rhodiola and 225 mg of Cordyceps
Study Arms  ICMJE
  • Placebo Comparator: Placebo of calcium
    Participants will consume 250 mg of calcium
    Intervention: Dietary Supplement: Placebo of calcium
  • Experimental: Rhodiola
    Participants will consume 250 mg of Rhodiola
    Intervention: Dietary Supplement: Rhodiola
  • Experimental: Rhodiola and Cordyceps
    Participants will consume a combination of 250 mg of Rhodiola and 225 mg of Cordyceps
    Intervention: Dietary Supplement: Rhodiola and Cordyceps
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2019) 		13
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2019
Actual Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body Mass Index between 18.5 and 35 kg/m^2
  • Non-smoking (assessed by Health History Questionnaire)
  • English-speaking
  • Regular participation in physical activity (>4 hours per week)

Exclusion Criteria:

  • Medical conditions that prohibit physical activity (assessed by Health History Questionnaire)
  • Pregnant women or women expecting/trying to become pregnant
  • BMI greater than or equal to 35 kg/m^2
  • Current smoker (assessed by Health History Questionnaire)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929575
Other Study ID Numbers  ICMJE CPKINE454
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Todd Hagobian, California Polytechnic State University-San Luis Obispo
Study Sponsor  ICMJE California Polytechnic State University-San Luis Obispo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Todd Hagobian, PhD California Polytechnic State University-San Luis Obispo
PRS Account California Polytechnic State University-San Luis Obispo
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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