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Assessing the Effects of a Buckwheat Beverage on Postprandial Glucose Metabolism on Healthy and T2D Individuals (BUCKFOOD)

17 aprile 2019 aggiornato da: University of Aberdeen

Buckwheat is a unique crop because is naturally rich in compounds that have shown beneficial effects on glucose metabolism.

A constant high glucose level in blood after meal consumption is an independent risk factor for cardiovascular complications and death. In order to prevent Type 2 Diabetes Mellitus (T2D) and/or its complications it is important to have a strict control of the blood glucose levels after a meal. There are known therapies for the control of the high glucose blood levels such as agents that act on intestinal digestion of carbohydrates and therapeutic agents that mimic the insulin response after a meal. The combination of these type of agents was commonly prescribed in the treatment of T2D.

The aim of the study is to assess the effect of a buckwheat beverage on postprandial glucose metabolism in healthy individuals and those with T2D controlled by medication and diet.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The ability of the buckwheat beverage to modulate postprandial sugar metabolism will be tested in a dietary study in healthy volunteers and people with T2D. Three groups will be recruited; healthy volunteers, individuals with T2D controlled by medication and individuals with T2D controlled by diet and lifestyle only.

For the human volunteers who have T2D controlled by medication, there will be targeted those who have been prescribed metformin only.

The volunteers will visit the Human Nutrition Unit (HNU) three times (a screening visit and two study visits) during the course of the study.

A minimum of two weeks between the study visits will be allowed.

Screening visit:

Once the consent form has been signed, the volunteers taking part in the study will answer a specific health questionnaire and have their blood sugar level measured. The HbA1c (glycated haemoglobin) will be measured using the AS-100 (finger spot blood). We will follow the NHS guideline to establish the values for HbA1c. A normal HbA1c target is below 48 mmol/mol (or 6.5%).

In addition, for the volunteers with T2D, a consultant from the study research team will access the medical records to ensure their eligibility for the study. Permission will be obtained from the volunteers for this via the study consent form.

Dietary study test meal and control meal:

The test meal The buckwheat beverage is prepared from sprouted buckwheat flour without adding any extra sugar, spices or aromas. The test meal contains 100 g of the buckwheat beverage and 75 g glucose dissolved in 300 mL water followed by 100 mL water.

The control meal The control meal will be a standard OGT test containing 75 g glucose dissolved in 300 mL of water followed by 100 mL water.

Both meals will be advised to be consumed within 5 minutes. The T2D volunteers which are on metformin will be advised to take their medication as usual. We will record the dose and time when the metformin will be taken by the volunteers.

Dietary study visits:

Following recruitment, screening and consent, the three groups of volunteers will start the study by random allocation to one of the test meals. On the study day, the volunteers will be advised to come to the HNU in the morning after an overnight fasting (10 h). A cannula will be inserted into the volunteers' arm and baseline blood will be collected. The cannulation and blood sampling will be performed by trained phlebotomists. Additionally a baseline urine sample will be collected. The urine sample either will be brought in by the volunteers in the morning or produced in HNU before the test meals. The volunteers will be served the control and test meal (depending on allocation) and advised that it is to be consumed within five minutes. Volunteers which are on metformin will be asked to take their medication as usual.

For each study visit, blood will be collected at 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180 and 300 min. The blood will be collected in 4 mL lithium heparin tubes and 4 mL glucose (fluoride oxalate) tubes at each time point. A volume of 96 mL of blood will be collected at each study visit. Additionally a volume of 5 μL blood will be collected for each time point in order to instantly measure the glucose levels. At least two samples will be collected at t=0 in order to obtain a good baseline value.

The movements of the volunteers will be restricted to minimum for the entire blood collection period. They will be asked to stay resting and comfortable position and relaxed for the entire (300 min) sampling period and to not leave the HNU.

After five hours, once all the blood samples have been collected the cannula will be extracted from the volunteer's arm and lunch will be provided.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

54

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

      • Aberdeen, Regno Unito, AB 25 2ZD
        • Reclutamento
        • Rowett Institute, University of Aberdeen
        • Contatto:

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

Healthy and T2D (controlled by diet and lifestyle or metformin) volunteers; Age 18+; males and females.

Exclusion Criteria:

For the healthy group:

  • taking prescribed medication
  • HbA1c above 48mmol/mol (or 6.5%)
  • pregnant or breastfeeding
  • blood donation in the last three months
  • unable to give written informed consent
  • eating disorders such as anorexia, bulimia, binge eating or night eating syndrome.
  • significant health issue
  • taking vitamin or mineral supplements (unless they agree to discontinue supplementation 2 weeks or more before the start of the study)
  • Food allergies/intolerances

For the T2D groups:

  • T2D controlled by medication other than metformin
  • pregnant or breastfeeding
  • blood donation in the last three months
  • unable to give written informed consent
  • eating disorders such as anorexia, bulimia, binge eating or night eating syndrome.
  • any other significant health issue other than T2D
  • taking vitamin or mineral supplements (unless they agree to discontinue supplementation 2 weeks before the start of the study)
  • food allergies/intolerances

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 parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Control meal
The control meal will be a standard OGT test containing 75 g glucose dissolved in 300 mL of water followed by 100 mL water.
The effect of a buckwheat beverage on postprandial glucose metabolism in healthy individuals and those with T2D controlled by medication and diet will be studied.
Comparatore attivo: The test meal
The test meal contains 100 g of the buckwheat beverage and 75 g glucose dissolved in 300 mL water followed by 100 mL water.
The effect of a buckwheat beverage on postprandial glucose metabolism in healthy individuals and those with T2D controlled by medication and diet will be studied.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
post prandial blood glucose (recording cmax)
Lasso di tempo: five hours
Postprandial blood glucose levels after acute consumption of a buckwheat beverage, recording the maximum blood glucose concentration (c max) over the baseline after the consumption of a buckwheat beverage.
five hours
AUC for postprandial glucose
Lasso di tempo: five hours
Area under the curve described by the postprandial glucose level during five hours time
five hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
post prandial blood insulin in blood ( including AUC)
Lasso di tempo: five hours
Post prandial blood insulin levels after acute consumption of a buckwheat beverage. AUC (area under curve) for insulin for five hour interval.
five hours
Buckwheat beverage key bioactives bioavailability and metabolism.
Lasso di tempo: five hours
Plasma concentration of key bioactives (inositols and fagomines)
five hours
Urine ratio of myo and D-chiro inositol
Lasso di tempo: 0, 3 and 5 hours
Urine ratio of myo and D-chiro inositol after the consumption of a buckwheat beverage.
0, 3 and 5 hours
Urine glucose concentration
Lasso di tempo: 0, 3 and 5 hours
Glucose concentration in urine after the consumption of a buckwheat beverage.
0, 3 and 5 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

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)

7 marzo 2019

Completamento primario (Anticipato)

7 settembre 2020

Completamento dello studio (Anticipato)

31 marzo 2021

Date di iscrizione allo studio

Primo inviato

3 aprile 2019

Primo inviato che soddisfa i criteri di controllo qualità

17 aprile 2019

Primo Inserito (Effettivo)

22 aprile 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 aprile 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 aprile 2019

Ultimo verificato

1 aprile 2019

Maggiori informazioni

Termini relativi a questo studio

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 .

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