Glycaemic Response to High REsistant STarch Bread

NCT04197726 | Completed

• 1 other identifier: QIB02/2019
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Glucose Response

Keywords

Glycaemic response; Resistant starch; Bread

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in postprandial glucose concentration in interstitial fluid

  4 hours

• Ad libitum intake

  2 hours

• Change in postprandial glucose concentration in interstitial fluid

  4 hours

• Satiety

  3 hours

• Sensory questionnaire

  30 minutes

Study Arms (2)

sbeIIa/b white bread

EXPERIMENTAL

sbeIIa/b white bread with high resistant starch content

Other: sbeIIa/b white bread; Other: Control white bread

Control white bread

ACTIVE COMPARATOR

Reference white bread (wild-type)

Other: sbeIIa/b white bread; Other: Control white bread

Interventions

sbeIIa/b white bread OTHER

one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast

Control white bread; sbeIIa/b white bread

Control white bread OTHER

one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast

Control white bread; sbeIIa/b white bread

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Quadram Institute

Norwich, Norfolk, NR4 7UQ, United Kingdom

Location

Study Officials

• Marina Corrado, MSc

  PhD student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind randomised crossover study

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 13, 2019
• Study Start: January 6, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available after publication in scientific journal within 18 months of study completion
• Access Criteria: Data access will be reviewed by the study team

Locations

GB (1)