- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02003586
Effect of a Plant-based Ingredient on Generalized Hormonal Responses
8. april 2014 opdateret af: Unilever R&D
The study is designed to determine the extent to which foods containing a plant-based ingredient affect blood glucose and hormonal response in healthy subjects.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Gieres, Frankrig
- Eurofins Optimed Clinical research
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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
20 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Healthy males, Age at start of the study >20 and <50 years;
- Body mass index (BMI) ≥ 20,0 and ≤ 25,0 kg/m2;
- Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases);
- Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
- Agreeing to be informed about medically relevant personal test-results by a physician;
- Informed consent signed;
- Willing to comply to study protocol during study;
- Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research.
- Accessible veins on arms as determined by examination at screening.
Exclusion Criteria:
- Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
- Blood donation in the past 2 months;
- Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study;
- Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM;
- Reported intense sporting activities > 10h/w;
- Consumption of > 21 alcoholic drinks in a typical week;
- Not being used to eat breakfast;
- Reported use of any nicotine containing products in the six months preceding the study and during the study itself;
- Use of medication which interferes with study measurements;
- Reported dietary habits: medically prescribed diet, slimming diet;
- Not used to eat 3 meals a day;
- Vegetarian;
- Reported weight loss/gain (>10%) in the last six month before the study;
- Being an employee of Unilever and CRO;
- Allergy or intolerance to food products and aversion to food products provided during the study;
- Subject who cannot be contacted in case of emergency;
- Subject who, in the judgment of the investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
- Subject under guardianship;
- Subject who would receive more than 4500 euro's as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Plant-based ingredient to a starchy meal
Plant-based ingredient
|
|
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Andet: Starchy meal alone
No plant-based ingredient
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
AUC of post-prandial hormones
Tidsramme: 120 minutes
|
Amylin (total) will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 120 minutes
|
Ghrelin (active) will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 120 minutes
|
Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 120 minutes
|
Glucagon-like peptide-1 (GLP-1) (active) will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 120 minutes
|
Leptin will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 120 minutes
|
Pancreatic polypeptide (PP) will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 120 minutes
|
Peptide YY (PYY) (total) will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 120 minutes
|
Insulin will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 120 minutes
|
C-peptide will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 120 minutes
|
Glucagon will be assessed.
|
120 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
AUC of post-prandial hormones
Tidsramme: 180 and 240 minutes
|
Amylin (total) will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 180 and 240 minutes
|
Ghrelin (active) will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 180 and 240 minutes
|
Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 180 and 240 minutes
|
Pancreatic polypeptide (PP) will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 180 and 240 minutes
|
Peptide YY (PYY) (total) will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 180 and 240 minutes
|
Leptin will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 180 and 240 minutes
|
Glucagon will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 180 and 240 minutes
|
Insulin will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 180 and 240 minutes
|
C-peptide will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
Tidsramme: 180 and 240 minutes
|
Glucagon-like peptide-1 (GLP-1) (active) will be assessed.
|
180 and 240 minutes
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood glucose response (+iAUC)
Tidsramme: 120 and 180 minutes
|
Effect on blood glucose response.
|
120 and 180 minutes
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Yves DONAZZOLO, M.D., M.Sc., EUROFINS OPTIMED, GIERES - France
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. december 2013
Primær færdiggørelse (Faktiske)
1. januar 2014
Studieafslutning (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først indsendt
22. november 2013
Først indsendt, der opfyldte QC-kriterier
5. december 2013
Først opslået (Skøn)
6. december 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. april 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. april 2014
Sidst verificeret
1. januar 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- FDS-NAA-1462
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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