NCT03929575

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

April 24, 2019

Last Update Submit

January 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • VO2 max

    Maximum oxygen consumption using the Bruce Protocol

    90 minutes after baseline

Secondary Outcomes (3)

  • Gastrointestinal symptoms questionnaire

    Baseline, 90 minutes, 110 minutes

  • Blood glucose

    Baseline, 90 minutes, 110 minutes

  • Blood lactate

    Baseline, 90 minutes, 110 minutes

Study Arms (3)

Placebo of calcium

PLACEBO COMPARATOR

Participants will consume 250 mg of calcium

Dietary Supplement: Placebo of calcium

Rhodiola

EXPERIMENTAL

Participants will consume 250 mg of Rhodiola

Dietary Supplement: Rhodiola

Rhodiola and Cordyceps

EXPERIMENTAL

Participants will consume a combination of 250 mg of Rhodiola and 225 mg of Cordyceps

Dietary Supplement: Rhodiola and Cordyceps

Interventions

Placebo of calciumDIETARY_SUPPLEMENT

Ingestion of 250 mg of calcium

Placebo of calcium
RhodiolaDIETARY_SUPPLEMENT

Ingestion of 250 mg of Rhodiola

Rhodiola
Rhodiola and CordycepsDIETARY_SUPPLEMENT

Ingestion of 250 mg of Rhodiola and 225 mg of Cordyceps

Rhodiola and Cordyceps

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 93407, United States

Location

Study Officials

  • Todd Hagobian, PhD

    California Polytechnic State University-San Luis Obispo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Blocked-randomized, crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 29, 2019

Study Start

May 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations