The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses
Panoramica dello studio
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Sperimentale: 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 |
|
Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Post-prandial Glucose Concentrations
Lasso di tempo: 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
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 15HH3069
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 .