Exercise PerformanceNCT03044444
The Effect of a Citrus Extract on Exercise Performance in Moderately Trained Athletes
A study testing citrus extract in people with Exercise Performance, run by BioActor at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance
- What is being tested?
- citrus extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Apr 2017to 6 Apr 2018
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy idividuals
- Participants are amateur or (semi-) professional athletes in resistance or interval sports (engage in >4 hours of intense physical activity per week).
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Exercise Performance
- Being tested
- citrus extract, placebo
- Keywords
- performance, polyphenols, nutrition, sports
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citrus extractDietary supplement
Participants will receive either a low or high dose citrus extract
placeboOther
participants will receive 500mg of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| high dose citrus extract | Experimental | this group will receive a high dose (500mg/day) of the citrus extract for 8 weeks Receives: Dietary Supplement: citrus extract |
| low dose citrus extract | Experimental | this group will receive a low dose (400mg/day) of the citrus extract for 8 weeks Receives: Dietary Supplement: citrus extract |
| placebo | Placebo comparator | this group will receive a placebo (500mg maltodextrin per day) for 8 weeks Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak force output Wingate
Peak force output in Watts during a high intensity repeated sprint cycling exercise
Measured: 8 weeks
Secondary outcomes (5)
jumping height
jumping height in cm measured during a vertical jump exercise
Measured: 8 weeks
peak force output Handgrip
Peak force output in Watts during a handgrip strength test
Measured: 8 weeks
force output Jump
force output in W measured during a vertical jump exercise
Measured: 8 weeks
anaerobic capacity
total amount of power (W) generated in the first 30 seconds of the the triple Wingate cycle test
Measured: 8 weeks
running time
running time in minutes and seconds measured over 1600m
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start13 Apr 2017
- Primary completion6 Apr 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise PerformanceStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioActor
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Freddy Troost, Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044444
- Sponsor's protocol ID
- HES_PER_002
- Status last verified
- Jul 2020
- First submitted
- 30 Jan 2017
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Iersel LE, Stevens YR, Conchillo JM, Troost FJ. The effect of citrus flavonoid extract supplementation on anaerobic capacity in moderately trained athletes: a randomized controlled trial. J Int Soc Sports Nutr. 2021 Jan 6;18(1):2. doi: 10.1186/s12970-020-00399-w.
PubMed 33407631
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Effect of Long-term Citrus Extract Supplementation on Exercise-specific Performance in Moderately Trained Athletes
- ClinicalTrials.gov ID
- NCT03044444
- Acronym / sponsor ID
- HES_PER_002
- Conditions
- Exercise Performance
- Keywords
- performance, polyphenols, nutrition, sports
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- BioActorIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 7 Feb 2017 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high dose citrus extract | Experimental | Dietary Supplement: citrus extractthis group will receive a high dose (500mg/day) of the citrus extract for 8 weeks |
| low dose citrus extract | Experimental | Dietary Supplement: citrus extractthis group will receive a low dose (400mg/day) of the citrus extract for 8 weeks |
| placebo | Placebo comparator | Other: placebothis group will receive a placebo (500mg maltodextrin per day) for 8 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy idividuals
- Participants are amateur or (semi-) professional athletes in resistance or interval sports (engage in >4 hours of intense physical activity per week).
Key exclusion criteria (9 listed)
- 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.
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 extractParticipants will receive either a low or high dose citrus extract | Dietary supplement | high dose citrus extract, low dose citrus extract |
| placeboparticipants will receive 500mg of maltodextrin | Other | placebo |
Primary outcome
peak force output Wingate
Time frame: 8 weeks
Peak force output in Watts during a high intensity repeated sprint cycling exercise
5 secondary outcomes
jumping height
Time frame: 8 weeks
peak force output Handgrip
Time frame: 8 weeks
force output Jump
Time frame: 8 weeks
anaerobic capacity
Time frame: 8 weeks
running time
Time frame: 8 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 10 Jul 2020.
- Derived from this study: PubMed 33407631van Iersel LE, Stevens YR, Conchillo JM, Troost FJ. The effect of citrus flavonoid extract supplementation on anaerobic capacity in moderately trained athletes: a randomized controlled trial. J Int Soc Sports Nutr. 2021 Jan 6;18(1):2. doi: 10.1186/s12970-020-00399-w.
- Individual participant dataSharing planned: No
Related trials for Exercise Performance
Not yet recruiting
Acute Effects of Breathing Resistance During Exercise in Football Players
Respiratory Muscle Function and Football Performance
Not yet recruiting
Effect of HMB Supplementation and Vivifrail Exercise on Body Composition, Handgrip Strength and Physical Performance in Women Over 60 Years of Age
Aging, Muscle Strength
Not yet recruiting
"CORE Training for Musculoskeletal Health: A Study on Adaptive Exercise Protocols"
Core Muscle Weakness, Postural Control Deficit
RecruitingObservational study
Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Frailty, Fall Risk, Fall Prevention
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
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.
Freddy Troost, Dr. principal investigator
Maastricht University
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 extract in people with Exercise Performance, 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 2 inclusion and 9 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 10 Jul 2020. 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?
peak force output Wingate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03044444, which also lists 1 linked publication.
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 10 Jul 2020.