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

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

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

24

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 45 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Glycaemic index values of five cereal products
Zeitfenster: 2 hours after food consumption
Determination of GI in both Caucasian and Asian subjects
2 hours after food consumption

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Glycaemic response assessed by the glycemic index (GI) values of five cereal products
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Mitarbeiter

Ermittler

  • Hauptermittler: Jennie Brand Miller, University of Sydney

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2015

Primärer Abschluss (Tatsächlich)

1. März 2016

Studienabschluss (Tatsächlich)

1. April 2016

Studienanmeldedaten

Zuerst eingereicht

30. Oktober 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Januar 2016

Zuerst gepostet (Schätzen)

8. Januar 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. September 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. September 2017

Zuletzt verifiziert

1. September 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KBE043

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