- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05291806
Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
29 giugno 2022 aggiornato da: Aventure AB
The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response.
The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
17
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Lund, Svezia
- Aventure AB
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 35 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Male or Female, 35 to 65 years of age
- BMI 18.5-29.9 kg/m2
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
- Healthy as determined by medical history and information provided by the volunteer.
- Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
- Has given voluntary, written, informed consent to participate in the study.
Exclusion Criteria:
- Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4)
- Women who are pregnant or breast feeding
- Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
- Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.
- Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
- Use of antibiotics within 2 weeks of enrollment
- Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- Allergy to ingredients included in investigational product, reference, or standardized meal
- Participants restricted to a vegetarian or vegan diet
- Intolerance to gluten
- Individuals who are averse to venous catheterization or capillary blood sampling
- Currently active smokers (or using other tobacco products, and e-cigarettes)
- Unstable medical conditions as determined by QI
- Participation in other clinical research trials
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Acute infection
Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
-
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: Reference
|
This intervention is based on white rice.
|
Comparatore attivo: Whole cereal kernels Dose A
|
This wholegrain intervention contains whole cereal kernels.
|
Comparatore attivo: Whole cereal kernels Dose B
|
This wholegrain intervention contains whole cereal kernels.
|
Comparatore attivo: Cut cereal kernels Dose A
|
This wholegrain intervention contains cut cereal kernels.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Postprandial capillary blood glucose iAUC (0-120 min)
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Postprandial capillary blood glucose Cmax
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Postprandial capillary blood glucose Tmax
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Fasting capillary blood glucose
Lasso di tempo: Outcome measures will be assessed just before the standardized meal is consumed.
|
The change in fasting capillary blood glucose the morning after consuming either wholegrain products or reference.
|
Outcome measures will be assessed just before the standardized meal is consumed.
|
Postprandial capillary blood glucose iAUC (0-60 min)
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Postprandial Insulin iAUC(0-120 min)
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Postprandial Insulin Cmax
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in Cmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Postprandial Insulin Tmax
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in Tmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Fasting Insulin
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in fasting venous blood insulin the morning after consuming either wholegrain products or reference.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Postprandial insulin iAUC (0-60 min)
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Fasting GLP-1
Lasso di tempo: Outcome measures will be assessed just before the standardized meal is consumed.
|
The change in fasting GLP-1 the morning after consuming either wholegrain products or reference.
|
Outcome measures will be assessed just before the standardized meal is consumed.
|
GLP-1 iAUC(0-120 min)
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
GLP-1 iAUC(0-60 min)
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in the1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
GLP-1 Cmax
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The changein GLP-1 between wholegrain products and reference in Cmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
GLP-1 Tmax
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in Tmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Fasting PYY
Lasso di tempo: Outcome measures will be assessed just before the standardized meal is consumed.
|
The change in fasting PYY the morning after consuming either wholegrain products or reference.
|
Outcome measures will be assessed just before the standardized meal is consumed.
|
PYY 2-hour mean concentration
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in PYY between the wholegrain products and the reference in the 2-hour mean concentration after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
PYY 1-hour mean concentration
Lasso di tempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in PYY between the wholegrain products and the reference in the 1-hour mean concentration after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
17 marzo 2022
Completamento primario (Effettivo)
13 giugno 2022
Completamento dello studio (Effettivo)
13 giugno 2022
Date di iscrizione allo studio
Primo inviato
14 marzo 2022
Primo inviato che soddisfa i criteri di controllo qualità
14 marzo 2022
Primo Inserito (Effettivo)
23 marzo 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 luglio 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 giugno 2022
Ultimo verificato
1 marzo 2022
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- TSP2201
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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 .
Prove cliniche su Risposta della glicemia
-
Zhongnan HospitalReclutamentoMicrotrapianto di UCB (Cord Blood) nel trattamento della leucemia mieloide acuta (AML) di nuova diagnosiCina
Prove cliniche su Reference Product
-
University Hospital Southampton NHS Foundation...Medical Research Council; University of SouthamptonCompletato
-
University Hospital Southampton NHS Foundation...Medical Research Council; University of Southampton; National Institute for Health... e altri collaboratoriAttivo, non reclutanteModifica della dietaRegno Unito
-
Suranaree University of TechnologyCompletatoIl fenomeno della diminuzione della resistenza elettrica all'interno delle camere conduttrici, determinando l'aumento della proprietà conduttivaTailandia
-
Pennington Biomedical Research CenterSamsungCompletatoComposizione corporea | Misure di circonferenza | Misurazioni dello spessore del tessutoStati Uniti