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

13. september 2017 oppdatert 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.

Studieoversikt

Detaljert beskrivelse

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.

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

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

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

18 år til 45 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Eksperimentell: 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.
Eksperimentell: 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.
Eksperimentell: 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.
Eksperimentell: 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.
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Glycaemic index values of five cereal products
Tidsramme: 2 hours after food consumption
Determination of GI in both Caucasian and Asian subjects
2 hours after food consumption

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Glycaemic response assessed by the glycemic index (GI) values of five cereal products
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Jennie Brand Miller, University of Sydney

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. oktober 2015

Primær fullføring (Faktiske)

1. mars 2016

Studiet fullført (Faktiske)

1. april 2016

Datoer for studieregistrering

Først innsendt

30. oktober 2015

Først innsendt som oppfylte QC-kriteriene

6. januar 2016

Først lagt ut (Anslag)

8. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. september 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. september 2017

Sist bekreftet

1. september 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KBE043

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