- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03044444
The Effect of a Citrus Extract on Exercise Performance in Moderately Trained Athletes
July 8, 2020 updated by: BioActor
Establishing the Effect of Long-term Citrus Extract Supplementation on Exercise-specific Performance in Moderately Trained Athletes
In this study, the effect of citrus extract on exercise performance will be investigated.
The study consists of three groups: one group will receive a high dose citrus extract, one group will receive a low dose citrus extract and the last group will receive a placebo.
After four and eight weeks the effects on performance are measured through a Wingate cycling test.
It is expected that exercise performance will increase in the citrus extract groups, compared to the placebo group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
93
Phase
- 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
-
-
Limburg
-
Sittard, Limburg, Netherlands, 6135LG
- High Performance Center
-
-
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
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy idividuals
- Participants are amateur or (semi-) professional athletes in resistance or interval sports (engage in >4 hours of intense physical activity per week).
Exclusion Criteria:
- Use of creatine supplements and/or anabolic steroids.
- Allergy to test product/placebo
- Allergy to citrus fruits
- BMI lower than 18 or higher than 30
- Recent muscle injury in less than one month before the start of the study.
- Cardiovascular complications
- Use of medication that may interfere with the study results
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study.
- Abuse of products; alcohol (> 20 alcoholic units per week) and drugs.
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: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: high dose citrus extract
this group will receive a high dose (500mg/day) of the citrus extract for 8 weeks
|
Participants will receive either a low or high dose citrus extract
|
EXPERIMENTAL: low dose citrus extract
this group will receive a low dose (400mg/day) of the citrus extract for 8 weeks
|
Participants will receive either a low or high dose citrus extract
|
PLACEBO_COMPARATOR: placebo
this group will receive a placebo (500mg maltodextrin per day) for 8 weeks
|
participants will receive 500mg of maltodextrin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
peak force output Wingate
Time Frame: 8 weeks
|
Peak force output in Watts during a high intensity repeated sprint cycling exercise
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
jumping height
Time Frame: 8 weeks
|
jumping height in cm measured during a vertical jump exercise
|
8 weeks
|
peak force output Handgrip
Time Frame: 8 weeks
|
Peak force output in Watts during a handgrip strength test
|
8 weeks
|
force output Jump
Time Frame: 8 weeks
|
force output in W measured during a vertical jump exercise
|
8 weeks
|
anaerobic capacity
Time Frame: 8 weeks
|
total amount of power (W) generated in the first 30 seconds of the the triple Wingate cycle test
|
8 weeks
|
running time
Time Frame: 8 weeks
|
running time in minutes and seconds measured over 1600m
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lactate
Time Frame: 8 weeks
|
post-exercise blood lactate in mmol/L after triple Wingate cycle exercise test
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Freddy Troost, Dr., Maastricht University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
April 13, 2017
Primary Completion (ACTUAL)
April 6, 2018
Study Completion (ACTUAL)
April 6, 2018
Study Registration Dates
First Submitted
January 30, 2017
First Submitted That Met QC Criteria
February 2, 2017
First Posted (ESTIMATE)
February 7, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 10, 2020
Last Update Submitted That Met QC Criteria
July 8, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HES_PER_002
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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