Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

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

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

24

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 45 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.
Sperimentale: 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.
Sperimentale: 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.
Sperimentale: 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.
Sperimentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Glycaemic index values of five cereal products
Lasso di tempo: 2 hours after food consumption
Determination of GI in both Caucasian and Asian subjects
2 hours after food consumption

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Glycaemic response assessed by the glycemic index (GI) values of five cereal products
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Investigatore principale: Jennie Brand Miller, University of Sydney

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2015

Completamento primario (Effettivo)

1 marzo 2016

Completamento dello studio (Effettivo)

1 aprile 2016

Date di iscrizione allo studio

Primo inviato

30 ottobre 2015

Primo inviato che soddisfa i criteri di controllo qualità

6 gennaio 2016

Primo Inserito (Stima)

8 gennaio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 settembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 settembre 2017

Ultimo verificato

1 settembre 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KBE043

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Product A: NP-0148

Sottoscrivi