- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929575
Effects of Herbal Supplements on Endurance Exercise Performance
January 25, 2021 updated by: Todd Hagobian, California Polytechnic State University-San Luis Obispo
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Luis Obispo, California, United States, 93407
- California Polytechnic State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 28 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo of calcium
Participants will consume 250 mg of calcium
|
Ingestion of 250 mg of calcium
|
Experimental: Rhodiola
Participants will consume 250 mg of 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
|
Ingestion of 250 mg of Rhodiola and 225 mg of Cordyceps
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2 max
Time Frame: 90 minutes after baseline
|
Maximum oxygen consumption using the Bruce Protocol
|
90 minutes after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 90 minutes, 110 minutes
|
Blood glucose
Time Frame: Baseline, 90 minutes, 110 minutes
|
Plasma glucose assessed by finger stick
|
Baseline, 90 minutes, 110 minutes
|
Blood lactate
Time Frame: Baseline, 90 minutes, 110 minutes
|
Plasma lactate assessed by finger stick
|
Baseline, 90 minutes, 110 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Todd Hagobian, PhD, California Polytechnic State University-San Luis Obispo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
April 24, 2019
First Submitted That Met QC Criteria
April 25, 2019
First Posted (Actual)
April 29, 2019
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPKINE454
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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