Exercise PerformanceNCT03929575
Effects of Herbal Supplements on Endurance Exercise Performance
A study testing Rhodiola and Rhodiola and Cordyceps in people with Exercise Performance, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance
- What is being tested?
- Rhodiola and Rhodiola and Cordyceps
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
California Polytechnic State University
San Luis Obispo, California, 93407
About this study
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).
Read the 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.
- Conditions
- Exercise Performance
- Being tested
- Placebo of calcium, Rhodiola, Rhodiola and Cordyceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo of calciumDietary supplement
Ingestion of 250 mg of calcium
RhodiolaDietary supplement
Ingestion of 250 mg of Rhodiola
Rhodiola and CordycepsDietary supplement
Ingestion of 250 mg of Rhodiola and 225 mg of Cordyceps
| Study group | Role | What they receive |
|---|---|---|
| Placebo of calcium | Placebo comparator | Participants will consume 250 mg of calcium Receives: Dietary Supplement: Placebo of calcium |
| Rhodiola | Experimental | Participants will consume 250 mg of Rhodiola Receives: Dietary Supplement: Rhodiola |
| Rhodiola and Cordyceps | Experimental | Participants will consume a combination of 250 mg of Rhodiola and 225 mg of Cordyceps Receives: Dietary Supplement: Rhodiola and Cordyceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max
Maximum oxygen consumption using the Bruce Protocol
Measured: 90 minutes after baseline
Secondary outcomes (3)
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.
Measured: Baseline, 90 minutes, 110 minutes
Blood glucose
Plasma glucose assessed by finger stick
Measured: Baseline, 90 minutes, 110 minutes
Blood lactate
Plasma lactate assessed by finger stick
Measured: Baseline, 90 minutes, 110 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 May 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Blocked-randomized, crossover design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Hagobian, California Polytechnic State University-San Luis Obispo
- Investigators
- Todd Hagobian, PhD, Principal investigator, California Polytechnic State University-San Luis Obispo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929575
- Sponsor's protocol ID
- CPKINE454
- Status last verified
- Jan 2021
- First submitted
- 24 Apr 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Herbal Supplements on Endurance Exercise Performance
- ClinicalTrials.gov ID
- NCT03929575
- Acronym / sponsor ID
- CPKINE454
- Conditions
- Exercise Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Blocked-randomized, crossover design
| Arm | Type | Receives |
|---|---|---|
| Placebo of calcium | Placebo comparator | Dietary Supplement: Placebo of calciumParticipants will consume 250 mg of calcium |
| Rhodiola | Experimental | Dietary Supplement: RhodiolaParticipants will consume 250 mg of Rhodiola |
| Rhodiola and Cordyceps | Experimental | Dietary Supplement: Rhodiola and CordycepsParticipants will consume a combination of 250 mg of Rhodiola and 225 mg of Cordyceps |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo of calciumIngestion of 250 mg of calcium | Dietary supplement | Placebo of calcium |
| RhodiolaIngestion of 250 mg of Rhodiola | Dietary supplement | Rhodiola |
| Rhodiola and CordycepsIngestion of 250 mg of Rhodiola and 225 mg of Cordyceps | Dietary supplement | Rhodiola and Cordyceps |
Primary outcome
VO2 max
Time frame: 90 minutes after baseline
Maximum oxygen consumption using the Bruce Protocol
3 secondary outcomes
Gastrointestinal symptoms questionnaire
Time frame: Baseline, 90 minutes, 110 minutes
Blood glucose
Time frame: Baseline, 90 minutes, 110 minutes
Blood lactate
Time frame: Baseline, 90 minutes, 110 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Hagobian, PhD principal investigator
California Polytechnic State University-San Luis Obispo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhodiola and Rhodiola and Cordyceps in people with Exercise Performance, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max (time frame: 90 minutes after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.