Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of an Orange Peel Extract on Exercise Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787733
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : June 3, 2016
Sponsor:
Collaborator:
InnoSportNL
Information provided by (Responsible Party):
Bioactor, Maastricht University Medical Center

Brief Summary:

Rationale: Numerous studies have shown the positive effect of a healthy diet and regular moderate exercise. Although, exercise has also been correlated with an increase in reactive oxygen species (ROS) production and a higher incidence of injury. ROS production seems to induce muscle damage, which reduces muscle performance and induces fatigue. Increasing muscle recovery could be an effective way to increase exercise performance. Several food ingredients have been of growing interest due to their specific functioning on the human body. Citrus flavonoids are abundantly available in citrus fruits. Prior studies show a positive effect of citrus flavonoids on endothelial function, by promoting vasodilation. In addition it has a positive effect on the nitric oxide (NO) synthesis, a known compound in regulating endothelial response. This capacity of citrus flavonoids could be useful in stimulating performance and recovery after exercise. Additionally, the ability of scavenging ROS could reduce muscle damage caused by exercise induced oxidative damage.

Objective: Determine the 4-week effect of daily citrus flavonoid supplementation on exercise recovery and performance.

Study design: Randomized, double-blind, placebo-controlled study with parallel design, in which 40 subjects engage in three exercise sessions. The sessions will be subdivided into a pre-test and test 1 and 2. Between test 1 and 2, participants receive daily for 4 weeks citrus flavonoid supplement or a placebo. Each day, subjects should consume 2 capsules each morning, containing in total 500 mg of citrus flavonoids or 500 mg placebo.

Study population: The subjects will be healthy normal weight trained males, with an age of 18 - 25. Additionally, subjects are non-smokers and free of a medication.

Intervention: Participants will be randomly placed in either the citrus flavonoid or placebo group. Participants will be instructed to ingest 2 capsules each morning for 4 consecutive weeks. Each capsule equals to 250 mg of citrus flavonoids or cellulose in case of the placebo treatment.

Main study parameters/endpoints: The main study parameter is the average amount of work load produced during the 10-minute time trail test. In addition, oxygen per minute will be determined as well as the heart rate. Finally, for each test, the subjective rating of perceived exertion (RPE) will be determined during the pre-test and test 1 and 2 by using a Borg scale.


Condition or disease Intervention/treatment Phase
Exercise Recovery and Endurance Dietary Supplement: Citrus flavonoid Dietary Supplement: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Establishing the Effect of Long-term Orange Peel Extract Supplementation on Exercise Performance and Recovery
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Citrus flavonoid
Citrus peel extract containing >90% flavonoids
Dietary Supplement: Citrus flavonoid
Daily dose of 500mg divided over two capsules

Placebo Comparator: Placebo
Identical looking placebo
Dietary Supplement: Placebo
Daily dose of 500mg divided over two capsules




Primary Outcome Measures :
  1. Average force output (Watts) in endurance cycling exercise after pre-exhaustive exercise [ Time Frame: 4 week ]
    Average force output is measured through a cycle ergometer


Secondary Outcome Measures :
  1. Maximum oxygen uptake (ml/kg/min) in endurance cycling exercise after pre-exhaustive exercise [ Time Frame: 4 weeks ]
    Maximum oxygen uptake is measured through an oxygen mask



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Trained participants, defined as engaging at least 3 times a week in moderate to high physical activity for a minimum of 30 minutes
  • Non-smoking, defined as no smoking for the last 6 months
  • Participants are capable and willing to give written informed consent voluntarily after receiving detailed information from the researchers

Exclusion Criteria:

  • Cardiovascular complications
  • Extreme BMI (i.e. lower than 18 or higher than 30)
  • Use of medication
  • Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
  • Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
  • 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
  • Failure to comply prohibited intake of hesperidin containing food products during study period. A list with forbidden food products will be provided to participant
  • History of any side effects towards the intake of flavonoids or citrus fruits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787733


Locations
Layout table for location information
Netherlands
InnoSportLab Papendal
Arnhem, Gelderland, Netherlands, 6816VD
Sponsors and Collaborators
Bioactor
InnoSportNL
Investigators
Layout table for investigator information
Principal Investigator: Bouke Salden, Drs. BioActor
Layout table for additonal information
Responsible Party: Bioactor, BioActorBV, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02787733    
Other Study ID Numbers: WU-PER-001
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Bioactor, Maastricht University Medical Center:
performance
recovery