Blood Glucose ResponseRESTNCT04197726
Glycaemic Response to High REsistant STarch Bread
A study testing sbeIIa/b white bread in people with Blood Glucose Response, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose Response
- What is being tested?
- sbeIIa/b white bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Blood Glucose Response
- Being tested
- sbeIIa/b white bread, Control white bread
- Keywords
- Glycaemic response, Resistant starch, Bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sbeIIa/b white breadOther
one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast
Control white breadOther
one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast
| Study group | Role | What they receive |
|---|---|---|
| sbeIIa/b white bread | Experimental | sbeIIa/b white bread with high resistant starch content Receives: Other: sbeIIa/b white bread; Other: Control white bread |
| Control white bread | Active comparator | Reference white bread (wild-type) Receives: Other: sbeIIa/b white bread; Other: Control white bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3.5 hours
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start6 Jan 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind randomised crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Marina Corrado, MSc, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197726
- Sponsor's protocol ID
- QIB02/2019
- Acronym
- REST
- Status last verified
- Feb 2022
- First submitted
- 9 Dec 2019
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemic Response to High REsistant STarch Bread
- ClinicalTrials.gov ID
- NCT04197726
- Acronym / sponsor ID
- REST / QIB02/2019
- Conditions
- Blood Glucose Response
- Keywords
- Glycaemic response, Resistant starch, Bread
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomised crossover study
| Arm | Type | Receives |
|---|---|---|
| sbeIIa/b white bread | Experimental | Other: sbeIIa/b white bread, Other: Control white breadsbeIIa/b white bread with high resistant starch content |
| Control white bread | Active comparator | Other: sbeIIa/b white bread, Other: Control white breadReference white bread (wild-type) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sbeIIa/b white breadone bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast | Other | Control white bread, sbeIIa/b white bread |
| Control white breadone bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast | Other | Control white bread, sbeIIa/b white bread |
Primary outcome
Change in postprandial capillary glucose concentration
Time frame: 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.
5 secondary outcomes
Change in postprandial glucose concentration in interstitial fluid
Time frame: 4 hours
Ad libitum intake
Time frame: 2 hours
Change in postprandial glucose concentration in interstitial fluid
Time frame: 4 hours
Satiety
Time frame: 3 hours
Sensory questionnaire
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Corrado, MSc principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sbeIIa/b white bread in people with Blood Glucose Response, run by Quadram Institute Bioscience at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postprandial capillary glucose concentration (time frame: 3.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.