Glycaemic Response to High REsistant STarch Bread (REST)

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.

Study Overview

• Status: Completed
• Conditions: Blood Glucose Response
• Intervention / Treatment: Other: sbeIIa/b white bread; Other: Control white bread

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UQ
      • Quadram Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sbeIIa/b white bread; sbeIIa/b white bread with high resistant starch content	Other: sbeIIa/b white bread; one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast; Other: Control white bread; one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast
Active Comparator: Control white bread; Reference white bread (wild-type)	Other: sbeIIa/b white bread; one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast; Other: Control white bread; one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postprandial capillary glucose concentration	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postprandial glucose concentration in interstitial fluid	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Quadram Institute Bioscience
• Collaborators: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Marina Corrado, MSc, PhD student

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Bread; Glycaemic response; Resistant starch
• Other Study ID Numbers: QIB02/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: Data will be available after publication in scientific journal within 18 months of study completion
• IPD Sharing Access Criteria: Data access will be reviewed by the study team
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No