- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02538653
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.
13. september 2017 opdateret af: Mondelēz International, Inc.
This study aimed at determining the 4-hours postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
This study aimed at determining the 4-hours postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content.
It is a laboratory-based research study with an open cross-over design, including 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years. 2 test sessions per subject are included in the study.
Foods are consumed in a random order according to a randomisation list.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New South Wales
-
Sydney, New South Wales, Australien, 2006
- University of Sydney
-
-
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 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Aged between 18-45 years.
- Non-smoker.
- BMI values between 19-30 kg/m2 (bounds included). Around half of the subjects will be normal weight and the other half overweight.
- Ethnicity. Subjects should have the closest characteristics compared to the American population. Not less than 75% but not more than 90% of the subjects should be Caucasian. Not more than 10% of the subjects will be of Asian or Asian Indian descent. The remaining subjects will be from other ethnic groups except from Australian Aborigines.
Healthy subjects with:
- Normal glucose tolerance (fasting blood glucose < 6.0 mmol/L during the first test session and results of oral glucose tolerance test conducted within the last 30 days within recommendations (fasting blood glucose < 6.0 mmol/L, 120 minute glucose < 8.9 mmol/L))
- 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 tointerfere 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)
- Subject from the Australian Aboriginal ethnicity.
- 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Sandwich biscuits high in SDS
50 g of sandwich product with high level of SDS together with a glass of 250 mL of Evian water.
|
Consumption of the high SDS product (50g) alone with a glass of water
|
|
Aktiv komparator: Co-extruded cereals low in SDS
48.3 g of co-extruded cereals low in SDS together with a glass of 250 mL of Evian water.
|
Consumption of the low SDS product (48.3
g) alone with a glass of water
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Postprandial changes in plasma glucose levels over 2 hours (iAUC [0-120 min]) after consumption of the test products
Tidsramme: 2 hours after food consumption
|
2 hours after food consumption
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Postprandial changes in glycaemia over 3 hours (iAUC [0-180]), 4h (iAUC[0-240]), during the second part of the morning (iAUC [120-240] and iAUC[180-240]) following the intake of the test products will be analysed.
Tidsramme: 4 hours after food consumption
|
4 hours after food consumption
|
|
Postprandial changes in insulinemia over 2 hours (iAUC [0-120]), over 3 hours (iAUC [0-180]), 4 hours (iAUC[0-240]), during the second part of the morning (iAUC [120-240] and iAUC [180-240]) following the intake of the test products will be analysed.
Tidsramme: 4 hours after food consumption
|
4 hours after food consumption
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The plasma glucose peak value and the time for this latter will also be calculated.
Tidsramme: 4 hours after food consumption
|
4 hours after food consumption
|
|
The plasma insulin peak value and the time for this latter will also be calculated.
Tidsramme: 4 hours after food consumption
|
4 hours after food consumption
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jennie Brand Miller, University of Sydney
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. september 2015
Primær færdiggørelse (Faktiske)
1. december 2015
Studieafslutning (Faktiske)
1. december 2015
Datoer for studieregistrering
Først indsendt
31. august 2015
Først indsendt, der opfyldte QC-kriterier
31. august 2015
Først opslået (Skøn)
2. september 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. september 2017
Sidst verificeret
1. september 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KBE042
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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