Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products

13 september 2017 uppdaterad av: Mondelēz International, Inc.
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups.

Studieöversikt

Detaljerad beskrivning

This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups. It is a laboratory-based research study, conducted in two different ethnic groups, with an open cross-over design, including 24 healthy non-smoking voluntary subjects, aged from 18 to 45 years. 12 subjects will be Caucasian and 12 subjects will be Asian. 8 test sessions per subject are included in the study. Foods are consumed in a random order according to a randomisation list. The impact of the ethnic group and the products will be determined.

Studietyp

Interventionell

Inskrivning (Faktisk)

24

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • New South Wales
      • Sydney, New South Wales, Australien, 2006
        • University of Sydney

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 45 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Aged between 18-45 years.
  • Non-smoker.
  • BMI values: between 19-25 kg/m2 (bounds included) for Caucasian subjects and between 19-23 kg/m2 (bounds included) for Asian subjects (WHO expert consultation).
  • Ethnicity: Caucasian subjects will have both parents from Caucasian ancestry. Asian subjects will have both parents from Asian country and will be born in an Asian country. Asian countries are: Brunei Darussalam, Cambodia, China, Dem. People's Republic of Korea, Hong Kong SAR (China), Indonesia, Japan, Lao People's Democratic Republic, Macao SAR (China), Malaysia, Mongolia, Myanmar, Philippines, Republic of Korea, Singapore, Taiwan, Thailand, Viet Nam.
  • Sex ratio: Around half of the subjects should be male and half of the subjects should be female within each study group. A plus or minus 1 subject tolerance will be accepted.
  • Healthy subjects with:

Normal glucose tolerance Normal laboratory values for various measures of metabolic health (full blood count, gamma-GT, AST, ALT, glucose, TAGs, total cholesterol, HDL-cholesterol, LDL-cholesterol); Normal systolic blood pressure (100-150 mmHg); Normal diastolic blood pressure (60-90 mmHg); Normal resting heart rate (50-90 beats per minutes after 3 minutes rest).

  • Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
  • Moderate level of physical activity (from basic daily activity to a high level of physical activity (regular physical activity at least 3 times per week))
  • Able to fast for at least 10 hours the night before each test session.
  • Able to refrain from eating legumes and drinking alcohol the day before each test session.
  • Subject covered by social security or covered by a similar system
  • Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits
  • Subject having given written consent to take part in the study.

Exclusion Criteria:

  • Following a restrictive diet.
  • Family history of Diabetes Mellitus or obesity
  • Suffering from any clinical, physical or mental illness.
  • Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
  • Taking any regular prescription medication at the time of inclusion (except regular oral contraception medication)
  • Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
  • Females who consistently suffer from premenstrual tension and marked changes in appetite during their menstrual cycle.
  • Subject having taken part in another clinical trial within the last week.
  • Subject currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
  • Subject undergoing general anaesthesia in the month prior to inclusion.
  • Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Product A: NP-0148
Cereal product belVita Milk & Cereals - High in SDS
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Experimentell: Product B: NP-0149
Cereal product belVita Honey & Nuts - High in SDS
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Experimentell: Product C: NP-0150
Cereal product belVita Mixed Berry - High in SDS
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Experimentell: Product D: NP-0151
Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Experimentell: Product E: NP-0152
Cereal product Kellogg's Trésor Duo Choco - Low in SDS
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Experimentell: Glucose reference
Glucose solution performed on three occasions
Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Glycaemic index values of five cereal products
Tidsram: 2 hours after food consumption
Determination of GI in both Caucasian and Asian subjects
2 hours after food consumption

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Glycaemic response assessed by the glycemic index (GI) values of five cereal products
Tidsram: 2 hours after food consumption
Determination of GI in the global population
2 hours after food consumption
Glycaemic response assessed by the postprandial changes in glycaemia over 2 hours (iAUC0-120) after consumption of the test products
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Glycaemic response assessed by the kinetic of glycemia over the 120 minutes
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Glycaemic response assessed by the peak value of glycemia
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Glycaemic response assessed by the delta value between baseline and peak values of glycemia
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Insulinaemic response assessed by the insulinemic index (II) values of five cereal products
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Insulinaemic response assessed by the postprandial changes in insulinemia over 2 hours (iAUC0-120) after consumption of the test products
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Insulinaemic response assessed by the kinetic of insulinemia over the 120 minutes
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Insulinaemic response assessed by the peak value of insulinemia
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Insulinaemic response assessed by the delta value between baseline and peak values of insulinemia
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Insulin / glucose ratio (II/GI) evaluation of five cereal products
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Postprandial changes in insulin / glucose over 2 hours (iAUC0-120) after consumption of the test products
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Kinetic of insulin / glucose over the 120 minutes
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Peak value of insulin / glucose ratio
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Delta peak value between baseline and peak values of insulin / glucose ratio
Tidsram: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Jennie Brand Miller, University of Sydney

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2015

Primärt slutförande (Faktisk)

1 mars 2016

Avslutad studie (Faktisk)

1 april 2016

Studieregistreringsdatum

Först inskickad

30 oktober 2015

Först inskickad som uppfyllde QC-kriterierna

6 januari 2016

Första postat (Uppskatta)

8 januari 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 september 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 september 2017

Senast verifierad

1 september 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KBE043

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera