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Glycaemic Response to High REsistant STarch Bread (REST)

16 februari 2022 uppdaterad av: Quadram Institute Bioscience
This study evaluates if the consumption of one sbeIIa/b white bread with high resistant starch content will result in a lower blood glucose response and increased satiety compared with reference white bread. All participants will be asked to consume once the sbeIIa/b white bread and the reference white bread during different visits.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

In an attempt to increase dietary fibre intake, research has focused on developing wheat-based food products with novel fibres and starches to complement fibre intake from whole grain foods. Resistant starch is starch that escapes digestion in the small intestine and may be fermented in the large intestine by the microbiota. Resistant starch is a type of dietary fibre and it is normally found in wheat-based foods made from refined flour but only in small amounts. White bread made from sbeIIa/b wheat, which has high levels of resistant starch (a type of fibre), is showing promise in modulating blood glucose response and increasing satiety compared with conventional white bread.

The primary aim of this study is to determine whether consumption of sbeIIa/b white bread at breakfast, gives rise to a lower postprandial blood glucose response compared with consumption of a reference white bread in healthy individuals.

Additional aims of the study include: determining whether consumption of sbeIIa/b white bread by healthy subjects, gives rise to a lower glucose concentration in interstitial fluid, as measured by a Continuous Glucose Monitoring system (CGM), compared with consumption of control white bread; and exploring satiety and energy intake changes in healthy individuals following consumption of sbeIIa/b white bread at breakfast, compared with consumption of control white bread.

Studietyp

Interventionell

Inskrivning (Faktisk)

21

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Norfolk
      • Norwich, Norfolk, Storbritannien, NR4 7UQ
        • Quadram Institute

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Men and women
  • Aged 18 to 65 years
  • BMI between 18-25 kg/m2
  • Non-smokers
  • Those that live within a 40-mile radius of Norwich

Exclusion Criteria:

  • Fasting glucose >6.1 mmol/L and/or HbA1c>42 mmol/mol, as assessed by a fasting blood test
  • Eligibility screening results indicate they are not suitable to take part in this study
  • Smokers (if they have smoked within the 6 weeks prior to the study or during the study)
  • Suffer from allergy, intolerance, or sensitivity to gluten, yeast or any of the food ingredients used in this study
  • Have a known allergy to adhesives that would prevent proper attachment of the Continuous Glucose Monitoring sensors
  • Are pregnant and/or have been pregnant in the last year or are lactating and/or breastfeeding
  • Are currently suffering from, or have ever suffered from eating disorders, any diagnosed gastrointestinal disease, gastrointestinal disorders including regular diarrhoea and constipation (excluding hiatus hernia unless symptomatic) or other inflammatory diseases like rheumatoid arthritis (RA), polymyalgia rheumatica or other connective tissues diseases
  • Have undergone gastrointestinal surgery; this will be assessed on an individual basis
  • Have been diagnosed with diabetes, anaemia as this may affect the study outcome
  • Have been diagnosed with any long-term medical condition that may affect the study outcome (e.g. cardiovascular diseases, cancer)
  • Regularly take over-the-counter medications for digestive/gastrointestinal conditions
  • Use medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including long-term steroids, antibiotics. They may be able to participate if 4 weeks or more have passed from the end of a course such medication
  • Regularly take laxatives (once a month or more) as this may affect blood glucose levels
  • Take certain dietary supplements or herbal remedies and are unwilling to stop taking them (if required) for two weeks prior to and during the study period
  • Are on, or plan to start, a diet programme that may affect the study outcome (e.g. 5:2 fasting diet) unless willing to abstain for 1 month prior to and during the study period
  • Went through a weight change of ≥ 3kg in the preceding 2 months
  • Have a recent history of substance abuse
  • Regularly consume more than 14 units of alcohol a week
  • Are unwilling to suspend smoking and vaping for the duration of the study.
  • Are participating in another research project that involves dietary intervention or blood sampling.
  • Are unwilling to provide GPs contact details
  • Are related to or living with any member of the study team.
  • Are unable to provide written informed consent
  • Have not donated blood or taken part in another dietary intervention in the last 16 weeks and are unwilling to wait until 16 weeks have elapsed
  • Those with abnormal blood pressure measurements

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: sbeIIa/b white bread
sbeIIa/b white bread with high resistant starch content
one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast
one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast
Aktiv komparator: Control white bread
Reference white bread (wild-type)
one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast
one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in postprandial capillary glucose concentration
Tidsram: 3.5 hours

Glucose concentration in capillary blood measured by finger prick test after the consumption of sbeIIa/b white bread compared to control white bread.

Measurements will be taken during intervention visit 1 and 2 at -15, -10, -5, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210 min.

3.5 hours

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in postprandial glucose concentration in interstitial fluid
Tidsram: 4 hours

Glucose concentration in interstitial fluid measured by continuous glucose monitoring system after the consumption of sbeIIa/b white bread compared to control white bread.

Measurements will be taken during intervention visit 1 and 2 between -30 to 210 min.

4 hours
Ad libitum intake
Tidsram: 2 hours

Mean energy intake (kcal) at lunch after consumption of sbeIIa/b and control white bread.

Measurements will be taken once during intervention visit 1 and 2.

2 hours
Change in postprandial glucose concentration in interstitial fluid
Tidsram: 4 hours

Glucose concentration in interstitial fluid measured by continuous glucose monitoring system after the consumption of ad libitum lunch to explore any second meal effects caused by prior intake of either sbeIIa/b white bread and control white bread at breakfast.

Measurements will be taken during intervention visit 1 and 2 between 225 to 465 min.

4 hours
Satiety
Tidsram: 3 hours

Change of hunger feeling (appetite) will be examined using visual analog scale (0-10), 0 least and 10 greatest.

Measurements will be taken during intervention visit 1 and 2, at 0, 32, 92, 182 min.

3 hours
Sensory questionnaire
Tidsram: 30 minutes

Sensory perception of sbeIIa/b white bread and control white bread will be evaluated using a nine-point hedonic scale to determine any differences overall acceptability based on specific attributes.

A Just-About-Right (JAR) scale with five anchor points will be used to measure the appropriateness of the level of specific attributes to evaluate aroma, appearance, taste and texture of breads.

Measurements will be taken once during intervention visit 1 and 2.

30 minutes

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Marina Corrado, MSc, PhD student

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 januari 2020

Primärt slutförande (Faktisk)

30 april 2021

Avslutad studie (Faktisk)

30 april 2021

Studieregistreringsdatum

Först inskickad

9 december 2019

Först inskickad som uppfyllde QC-kriterierna

12 december 2019

Första postat (Faktisk)

13 december 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 februari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 februari 2022

Senast verifierad

1 februari 2022

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • QIB02/2019

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

De-identified individual participant data for primary and secondary outcome measures will be made available

Tidsram för IPD-delning

Data will be available after publication in scientific journal within 18 months of study completion

Kriterier för IPD Sharing Access

Data access will be reviewed by the study team

IPD-delning som stöder informationstyp

  • Studieprotokoll
  • Statistisk analysplan (SAP)
  • Informerat samtycke (ICF)
  • Klinisk studierapport (CSR)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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