Exercise Recovery and EnduranceNCT02787733
The Effect of an Orange Peel Extract on Exercise Performance
A study testing Citrus flavonoid in people with Exercise Recovery and Endurance, run by Bioactor at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Recovery and Endurance
- What is being tested?
- Citrus flavonoid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing the Effect of Long-term Orange Peel Extract Supplementation on Exercise Performance and Recovery
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.
Read more
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.
- Conditions
- Exercise Recovery and Endurance
- Being tested
- Citrus flavonoid, Placebo
- Keywords
- performance, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrus flavonoidDietary supplement
Daily dose of 500mg divided over two capsules
PlaceboDietary supplement
Daily dose of 500mg divided over two capsules
| Study group | Role | What they receive |
|---|---|---|
| Citrus flavonoid | Experimental | Citrus peel extract containing >90% flavonoids Receives: Dietary Supplement: Citrus flavonoid |
| Placebo | Placebo comparator | Identical looking placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average force output (Watts) in endurance cycling exercise after pre-exhaustive exercise
Average force output is measured through a cycle ergometer
Measured: 4 week
Secondary outcomes (1)
Maximum oxygen uptake (ml/kg/min) in endurance cycling exercise after pre-exhaustive exercise
Maximum oxygen uptake is measured through an oxygen mask
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Recovery and EnduranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioactor
- Sponsor type
- University, hospital or other
- Collaborators
- InnoSportNL
- Responsible party
- Sponsor-investigator, Bioactor, Maastricht University Medical Center
- Investigators
- Bouke Salden, Drs., Principal investigator, BioActor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787733
- Sponsor's protocol ID
- WU-PER-001
- Status last verified
- Jun 2016
- First submitted
- 24 May 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Effect of Long-term Orange Peel Extract Supplementation on Exercise Performance and Recovery
- ClinicalTrials.gov ID
- NCT02787733
- Acronym / sponsor ID
- WU-PER-001
- Conditions
- Exercise Recovery and Endurance
- Keywords
- performance, recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- BioactorUniversity, hospital or other
- Collaborators
- InnoSportNL
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citrus flavonoid | Experimental | Dietary Supplement: Citrus flavonoidCitrus peel extract containing >90% flavonoids |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIdentical looking placebo |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citrus flavonoidDaily dose of 500mg divided over two capsules | Dietary supplement | Citrus flavonoid |
| PlaceboDaily dose of 500mg divided over two capsules | Dietary supplement | Placebo |
Primary outcome
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
1 secondary outcome
Maximum oxygen uptake (ml/kg/min) in endurance cycling exercise after pre-exhaustive exercise
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bouke Salden, Drs. principal investigator
BioActor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citrus flavonoid in people with Exercise Recovery and Endurance, run by Bioactor at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average force output (Watts) in endurance cycling exercise after pre-exhaustive exercise (time frame: 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.