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The Effect of Continuous Sipping of a Glucose Solution on Markers of Oxidation in Men and Women (AOGI)

11. marts 2013 opdateret af: Thomas Wolever, University of Toronto
The objective of this study is to determine the effect of reducing the rate of glucose absorption on oxidative stress after eating and to compare it with the effects of vitamin C. The hypothesis is that reducing the rate of glucose absorption will reduce oxidative stress to a similar extent as 1g vitamin C.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Recently, much attention has been paid to evidence that abnormalities of the postprandial state (hyperglycemia) are important contributing factors to the development of chronic disease. This attention has increased interest in the role low glycemic index (GI) foods could potentially play in preventing postprandial oxidative burst/stress. GI is a means by which to categorize carbohydrate according to their postprandial glycemic response. Low GI foods promote slow intestinal absorption, prolonged and less pronounced postprandial glycemia, may decrease risk of chronic disease, as well as provide metabolic benefit to people living with glucose abnormalities as well as those with normal glucose. Few studies have been conducted looking at the potential relationship between GI and oxidation and are limited by dietary/lifestyle confounders. The proposed study has been developed to eliminate these confounders. Hypotheses (3): 1. Sipping glucose slowly over 3h will result in less oxidative stress than ingesting the same amount of glucose as a bolus over 5min. 2. Sipping glucose will reduce oxidative stress to the same extent as 1g of oral vitamin C. 3. The effect of sipping glucose on oxidative stress will occur sooner than that of vitamin C.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • healthy males or females
  • 18 to 75 years

Exclusion Criteria:

  • diabetes
  • recent hospitalization

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Glucose bolus alone
50g glucose dissolved in water and consumed within 5 minutes.
Kosttilskud: glucose bolus
50g anhydrous glucose dissolved in 300ml water consumed within 10min followed by a lunch (cheese sandwich, fruit and milk) at 4h.
Eksperimentel: Glucose sipping alone
50g glucose dissolved in water and consumed gradually over 3 hours.
Kosttilskud: Glucose sipping
50g anhydrous glucose dissolved in 300ml water consumed at rate of 25ml per 15min followed by a lunch (cheese sandwich, fruit and milk) at 4h.
Aktiv komparator: Glucose bolus plus 1g vitamin C
50g glucose dissolved in water and consumed in 5 minutes with 1g vitamin C
Kosttilskud: Glucose bolus plus 1g vitamin C
50g anhydrous glucose dissolved in 300ml water consumed within 10min with 1g vitamin C followed by a lunch (cheese sandwich, fruit and milk) at 4h.
Eksperimentel: Glucose sipping plus 1g vitamin C
50g glucose dissolved in water and consumed gradually of 3 hours. In addition 1g vitamin C will be taken with the first mouthful of glucose solution.
Kosttilskud: Glucose sipping plus 1g vitamin C
50g anhydrous glucose dissolved in 300ml water consumed at rate of 25ml per 15min. 1g vitamin C taken with first 25ml. Followed by a lunch (cheese sandwich, fruit and milk) at 4h.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incremental Area Under the Curve over 4 hours in serum TRAP (total peroxyl radical-trapping potential)
Tidsramme: Four (4) hours after starting to eat the test meal.
Four (4) hours after starting to eat the test meal.

Sekundære resultatmål

Resultatmål
Tidsramme
Change over 6 hours from baseline in Plasma glucose
Tidsramme: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Change over 6 hours from baseline in Plasma insulin
Tidsramme: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Change over 6 hours from baseline in Plasma free-fatty acids
Tidsramme: Baseline and hourly for 6h
Baseline and hourly for 6h
Change over 6 hours from baseline in Serum vitamin C
Tidsramme: Baseline and 2, 4 and 6h
Baseline and 2, 4 and 6h
Change over 6 hours from baseline in C-reactive protein
Tidsramme: Baseline and 2, 4 and 6h
Baseline and 2, 4 and 6h
Change over 6 hours from baseline in Blood pressure
Tidsramme: Baseline and 1, 2, 4, 5 and 6h
Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Pulse
Tidsramme: Baseline and 1, 2, 4, 5 and 6h
Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Pulse pressure
Tidsramme: Baseline and 1, 2, 4, 5 and 6h
Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Augmentation index
Tidsramme: Baseline and 1, 2, 4, 5 and 6h
Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Oxidized LDL
Tidsramme: Baseline and hourly for 6hr
Baseline and hourly for 6hr
Change from baseline in serum TRAP over 6 hours
Tidsramme: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min

Samarbejdspartnere og efterforskere

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

Sponsor

University of Toronto

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)

Efterforskere

  • Ledende efterforsker: Thomas MS Wolever, BMBCh PhD DM, University of Toronto
  • Studieleder: Shannan Grant, MSc, RD, University of Toronto

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. august 2010

Primær færdiggørelse (Faktiske)

1. juni 2011

Studieafslutning (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først indsendt

3. august 2011

Først indsendt, der opfyldte QC-kriterier

23. september 2011

Først opslået (Skøn)

27. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. marts 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. marts 2013

Sidst verificeret

1. marts 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25401TW

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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