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The Effect of an Orange Peel Extract on Exercise Performance

1. juni 2016 opdateret af: Bioactor, BioActor

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.

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Gelderland
      • Arnhem, Gelderland, Holland, 6816VD
        • InnoSportLab Papendal

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 25 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Citrus flavonoid
Citrus peel extract containing >90% flavonoids
Daily dose of 500mg divided over two capsules
Placebo komparator: Placebo
Identical looking placebo
Daily dose of 500mg divided over two capsules

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average force output (Watts) in endurance cycling exercise after pre-exhaustive exercise
Tidsramme: 4 week
Average force output is measured through a cycle ergometer
4 week

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum oxygen uptake (ml/kg/min) in endurance cycling exercise after pre-exhaustive exercise
Tidsramme: 4 weeks
Maximum oxygen uptake is measured through an oxygen mask
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Bouke Salden, Drs., BioActor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2014

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

24. maj 2016

Først indsendt, der opfyldte QC-kriterier

31. maj 2016

Først opslået (Skøn)

1. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • WU-PER-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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