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Coffee, Exercise, and Oxidative Stress

17. april 2014 oppdatert av: Société des Produits Nestlé (SPN)

Coffee and Oxidative Stress During Exercise in Healthy Humans

Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic acids) and bioavailability of these bioactive compounds is now somewhat well understood. In addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence remains to be observed in vivo. The objective of this trial is to understand if regular (14d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and plasma after an acute stress caused by exercise.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic acids) and bioavailability of these bioactive compounds is now somewhat well understood. However, even if chlorogenic acids are known to be antioxidants in the cup, reliable evidence remains to be observed in vivo.

After medical examination and approval, subjects will undergo 2 periods of 21 days. The first 7 days will consist of a dietary restriction to lower the polyphenols intake. Then subjects will drink at random one of the three treatments for 14 days (4 cups/day). Blood and urine samples will be collected throughout the study to evaluate in vivo effects on oxidative biomarkers. Furthermore, at day 21, subjects will undergo a physical regimen to increase acutely and transiently their oxidative damage. Blood and urine samples collected throughout this challenge will allow us to evaluate the effect of coffee intake in reducing oxidative damage created by exercise compared to placebo.

Studietype

Intervensjonell

Registrering (Faktiske)

24

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Lausanne, Sveits, 1000
        • Clinical Development Unit / Metabolic Unit

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 50 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy
  • Normal and overweight subjects (BMI 19 - 29), with lean mass below the 90th percentile value
  • Coffee drinkers with an average consumption of 1-3 cups per day
  • Having given informed consent
  • VO2 max as a function of age and gender, not higher than the values below:

Max oxygen uptake (VO2max, in ml/kg/min) in non athletes Age Males Females 20-29 49 41 30-39 47 39 40-49 45 37

Exclusion Criteria:

  • Digestive (intestinal, gastric, hepatic or pancreatic), renal or metabolic disease, as determined by the medical (screening) visit and a blood chemistry analysis (glucose, cholesterol, LDL, HDL, triglycerides, aspartate transaminase (ASAT), Alanine transaminase (ALAT), C reactive Protein (CRP), creatinin)
  • Subjects at cardio-vascular risk rated as intermediate or high (according to the Swiss Society of Cardiology, lipids group (www.agla.ch/p11-1-2.html), meaning those who show at least one of the following criteria:

    • History of coronary disease / atherosclerosis
    • Diabetes
    • High level of risk (familial hypercholesterolemia, hyperlipoproteinemia type III, hypertension)
    • Metabolic syndrome defined by the presence of at least 3 out of the following criteria :

Abdominal circumference > 102 cm in men, > 88 cm in women Fasting triglycerides ≥ 1.7 mmol/l HDL-cholesterol < 1.0 mmol/l in men, < 1.3 mmol/l in women Systolic arterial blood pressure ≥ 130 mm Hg and/or diastolic arterial blood pressure ≥ 85 mm Hg Plasma glucose ≥ 6.1 mmol/l

  • Anemia (Erythrocytes < 4.6 T/l (male) or < 4.2 T/l (women); Hemoglobin Hb < 13 g/dl (male) or Hb < 12 g/dl (women); Hematocrit Ht < 40% (male) or Ht < 37% (women); sera iron < 0.6 mg/l or plasma ferritin < 120 microg /l (male) or < 60 microg/l (non menopausal women)
  • Troubles of hemostasis as determined by platelets number, prothrombin time and activated partial thromboplastin time
  • Have had a gastrointestinal surgery, except appendicectomy
  • Pregnancy
  • History of food or medication allergy
  • Have a regular consumption of medication (only those impacting oxidative stress biomarkers (eg. impacting the metabolism of lipids / LDL / VLDL), oral contraception excepted)
  • Have taken antibiotic therapy within the last 3 months
  • Smokers (more than 5 cigarettes per day)
  • Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
  • Have a high alcohol consumption (more than 2 drinks/day)
  • Taking more than 3 cups of coffee per day
  • Consumption of illicit drugs
  • Subject who cannot be expected to comply with the study procedures, including consuming the test products.
  • Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: coffee
4 cups of soluble coffee per day (2.5g per cup)
maltodextrine with caffeine
Placebo komparator: Maltodextrine with caffeine
4 cups per day containing 2.5 g of product each
coffee versus placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
oxidative stress
Tidsramme: Change in oxidative stress from baseline to the last day of a 14-day period of product intake
Oxidative stress will be assessed though urine beta-isoprostane measurements
Change in oxidative stress from baseline to the last day of a 14-day period of product intake

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bioavailability of coffee antioxidative compounds
Tidsramme: Change in urine phenolic and chlorogenic acids from baseline to the last day of a 14-day period of product intake
Measures of phenolic and chlorogenic acids in urine
Change in urine phenolic and chlorogenic acids from baseline to the last day of a 14-day period of product intake

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Maurice Beaumont, MD, Clinical Development Unit / Metabolic Unit

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2012

Primær fullføring (Faktiske)

1. februar 2013

Studiet fullført (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først innsendt

8. april 2013

Først innsendt som oppfylte QC-kriteriene

11. april 2013

Først lagt ut (Anslag)

16. april 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

21. april 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. april 2014

Sist bekreftet

1. april 2014

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 10.38.MET

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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