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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03929575
Other study ID # CPKINE454
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date December 1, 2019

Study information

Verified date January 2021
Source California Polytechnic State University-San Luis Obispo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo of calcium
Ingestion of 250 mg of calcium
Rhodiola
Ingestion of 250 mg of Rhodiola
Rhodiola and Cordyceps
Ingestion of 250 mg of Rhodiola and 225 mg of Cordyceps

Locations

Country Name City State
United States California Polytechnic State University San Luis Obispo California

Sponsors (1)

Lead Sponsor Collaborator
California Polytechnic State University-San Luis Obispo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary VO2 max Maximum oxygen consumption using the Bruce Protocol 90 minutes after baseline
Secondary Gastrointestinal symptoms questionnaire 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. Baseline, 90 minutes, 110 minutes
Secondary Blood glucose Plasma glucose assessed by finger stick Baseline, 90 minutes, 110 minutes
Secondary Blood lactate Plasma lactate assessed by finger stick Baseline, 90 minutes, 110 minutes
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