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The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses

8. marts 2021 opdateret af: Imperial College London
Aims: To investigate the effects of different food structures on glucose concentrations and subsequent metabolic responses including insulin,GIP, GLP-1 DESIGN: A randomised, controlled, clinical trial.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Rationale:

There is very little evidence at the present time in the role of food structure in glucose homeostasis. There is circumstantial evidence that foods consumed intact have great effects on suppressing appetite.

To test the effect of three structurally different meals with the same nutritional content and volume on appetite regulation. Each participant will receive the following meals:

Solid meal group. Milled (intact-cell) meal group. Milled (destroyed-cell) meal group.

All of which will contain the same macro and micro nutrients from the same food sources

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Ikke anvendelig

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Gender: male and female
  • Age ≥ 18 years ≤ 65 years
  • Normal weight as classified by BMI 20-29.9 kg/m2
  • Healthy, not diagnosed with any chronic diseases assessed as appropriate for inclusion, based on the pre-study screening.
  • Willingness and ability to understand, participate and to comply with the study requirements
  • Willingness and ability to give written informed consent

Exclusion Criteria:

  • Has thyroid defects
  • Under hormone or steroids therapy
  • Is pregnant or lactating (female)
  • Had given birth within the past year (female)
  • Is taking drugs that could affect appetite or plasma glucose levels.
  • Is taking natural remedies that modulate appetite or plasma glucose levels.
  • Has excessive alcohol intake
  • Had blood donation within 12wks prior to start date
  • Psychiatric illness
  • Smokers
  • History of any disease with unknown outcome
  • Has diabetes
  • Has nut allergy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: whole chickpea
a test meal containing 26g available carbohydrates from chickpea (full structure)

all three meals are isocaloric but different in the chickpea structure( physical form):

• Whole chickpea, flour chickpea, intact cell flour chickpea

Eksperimentel: flour chickpea
a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)

all three meals are isocaloric but different in the chickpea structure( physical form):

• Whole chickpea, flour chickpea, intact cell flour chickpea

Eksperimentel: intact cell chickpea
a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)

all three meals are isocaloric but different in the chickpea structure( physical form):

• Whole chickpea, flour chickpea, intact cell flour chickpea

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post-prandial Glucose Concentrations
Tidsramme: before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal.

Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.

Data were not collected for intact cell chickpea hummus

before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal.
Post-prandial Blood Insulin Concentrations
Tidsramme: before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal.
Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.
before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
Tidsramme: before the consumption of the test meal at 0 min and then post test meal at 15, 30,60 ,90,120 and 180 minutes.

Blood GIP concentrations were assessed for each participant after each test meal: whole chickpea hummus, and Flour chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.

Data were not collected for intact cell chickpea hummus

before the consumption of the test meal at 0 min and then post test meal at 15, 30,60 ,90,120 and 180 minutes.
Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)
Tidsramme: baseline before the consumption of the test meal, and then 15,30,60,90,120,180 min after the consumption of the test meal.
Blood GLP-1 concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.
baseline before the consumption of the test meal, and then 15,30,60,90,120,180 min after the consumption of the test meal.
Energy Intake at a Meal Given in Excess
Tidsramme: post consumption of the test meal at 120 minutes
The difference in ad libitum food intake after 210 minutes post test meal to test the difference of energy intake following whole chickpea hummus, flour chickpea hummus, and intact cell chickpea hummus.
post consumption of the test meal at 120 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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 (Faktiske)

1. juli 2016

Primær færdiggørelse (Faktiske)

1. maj 2017

Studieafslutning (Faktiske)

1. juli 2018

Datoer for studieregistrering

Først indsendt

1. september 2017

Først indsendt, der opfyldte QC-kriterier

31. januar 2018

Først opslået (Faktiske)

6. februar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 15HH3069

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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