NCT02075892

Brief Summary

Purpose: To determine the acute effects of a mushroom blend vs. placebo on oxygen kinetics, aerobic power and time to fatigue in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

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

February 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

August 1, 2014

Enrollment Period

4 months

First QC Date

February 27, 2014

Last Update Submit

December 3, 2014

Conditions

Keywords

cordyceps, aerobic capacity, exercise performance, fatigue

Outcome Measures

Primary Outcomes (2)

  • Oxygen kinetics

    oxygen uptake and utilization using indirect calorimetry during a 6 min steady-state exercise bout

    during a 6 min

  • Critical Power

    3 min all-out cycling test to measure anaerobic and aerobic performance

    during a 3 min

Secondary Outcomes (3)

  • Lactate

    baseline, 2min, 3min, 6min (pre-post supplementation)

  • Cortisol

    during a 6 min

  • Maximal Oxygen Consumption

    during a graded exercise test to exhaustion

Study Arms (2)

Mushroom Blend

ACTIVE COMPARATOR

4 grams daily; oral; 7 and 21 days

Dietary Supplement: Mushroom Blend

Placebo

PLACEBO COMPARATOR

4 grams maltodextrin, oral, 7 and 21 days

Dietary Supplement: Placebo

Interventions

Mushroom BlendDIETARY_SUPPLEMENT

Scivation

Also known as: Cordyceps
Mushroom Blend
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant has been involved in exercise program for a minimum of one year prior to recruitment (≥ 3 d/wk)
  • Participant is able to exercise (i.e. no existing musculoskeletal injury)
  • Participant is willing and able to comply with the protocol
  • Participant is apparently healthy and free from disease, as determined by a health history questionnaire and physical
  • Participant agrees to abstain from smoking, caffeine, tobacco, and alcohol before testing days
  • Participant agrees to abstain from exercise 24 hours prior to each testing visit
  • Participant is not allergic to mushrooms

You may not qualify if:

  • Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders
  • Participant is using, or has used one of the following dietary supplements within 12 weeks prior to enrollment: Beta-alanine, Creatine, Carnosine or Taurine
  • Participant has lost or gained greater than ten pounds within the previous 3 month
  • Participant is currently enrolled in another clinical trial.
  • Participant has a known allergy or sensitivity to any ingredient in the test product or placebo (determined from health history questionnaire)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Physiology Laboratory, Fetzer Hall

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abbie Smith-Ryan, PhD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 3, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-08

Locations