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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 26 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
California Polytechnic State University-San Luis Obispo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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