NCT01718548

Brief Summary

Cordyceps Sinensis (CS) and Lingzhi extracts have been used in Chinese Medicine for many years for treatment of a variety of conditions. The aim of this study is to evaluate the effects of oral ingestion of CS and Lingzhi extracts of a period of 28 days on cardiopulmonary fitness and cognitive functioning in young, healthy physical education students.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

October 29, 2012

Last Update Submit

October 29, 2012

Conditions

Physical FitnessExecutive Function

Outcome Measures

Primary Outcomes (1)

  • Improvement in Cardiopulmonary Fitness after Ingestion of CS and Lingzhi Extracts

    Before and after 28-day ingestion of CS and Lingzhi extracts, subjects will undergo a graded exercise test on a treadmill and results will be compared.

    28 days

Other Outcomes (1)

  • Effect of CS and Lingzhi on Cognitive Functioning

    28 days

Study Arms (2)

CS and Lingzhi

ACTIVE COMPARATOR

CS liquid (each dosage is a bottle of liquid containing 30 ml: comprising 75% of CS, 6% Lingzhi, 6% shitake, 5% bamboo shoot, 2% honey, 0.1% potassium sorbet and 5.9% pure water) and Lingzhi capsule (each capsule contains 620mg of: 52.42% Lingzhi, 28.23% CS, and 19.35% soy gel ) ; one quarter bottle of CS to be ingested twice a day, and the Lingzhi capsule to be taken once a day, both for a period of 28 days.

Dietary Supplement: Cordyceps Sinensis (CS) and Lingzhi

Placebo

PLACEBO COMPARATOR

Liquid tea ingested twice a day and flour-filled capsules ingested once a day over a period of 28 days

Dietary Supplement: Tea and Flour

Interventions

Cordyceps Sinensis (CS) and LingzhiDIETARY_SUPPLEMENT
CS and Lingzhi
Tea and FlourDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physical education students

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wingate Institute

Netanya, Israel

Location

MeSH Terms

Interventions

TeaFlour

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesFood

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2012

First Posted

October 31, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

IL(1)