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Effects of Herbal Supplements on Endurance Exercise Performance

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ClinicalTrials.gov Identifier: NCT03929575
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Todd Hagobian, California Polytechnic State University-San Luis Obispo

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 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


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




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



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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929575


Contacts
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Contact: Todd A Hagobian, PhD 8053050627 thagobia@calpoly.edu
Contact: Rachel K Barnett 4153200208 rkbarnet@calpoly.edu

Locations
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United States, California
California Polytechnic State University Recruiting
San Luis Obispo, California, United States, 93407
Contact: Todd Hagobian, PhD    805-756-7511    thagobia@calpoly.edu   
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

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Responsible Party: Todd Hagobian, Principal Investigator, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier: NCT03929575     History of Changes
Other Study ID Numbers: CPKINE454
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Calcium
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents