Glycemic ResponseNCT03224806
Effect of Fiber Composite-enriched Breads on Glycemic Responses
A study testing Wholegrain bread, White bread and 15% fiber-rich bread in people with Glycemic Response, run by Glycemic Index Laboratories, Inc at 1 site in Canada.
Trial summary
Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glycemic Response
- What is being tested?
- Wholegrain bread, White bread and 15% fiber-rich bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jun 2014to 13 Jun 2014
- 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 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Good health
Who cannot join
- Known history of AIDS, hepatitis, diabetes or a heart condition
- Use of drugs which would increase risk to the subject or affect the results in the opinion of the medical director
- Any condition which would increase risk to the subject or affect the results in the opinion of the medical director
- Individuals who cannot or will not comply with experimental procedures or do not follow safety guidelines.
Trial locations and contacts
1 site in 1 country.
About this study
Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. The present study investigated the effect of enriching white wheat flour with wheat bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were studied on 4 separate days with each subject testing all 4 types of bread. On each test day subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood samples, they ate a portion of one of the breads containing 50g available carbohydrate and had further blood samples at intervals over 2 hours. They also rated their feelings of satiety fasting and at intervals over 2 hours.
Read the detailed description
Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. The present study investigated the effect of enriching white wheat flour with wheat bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were studied on 4 separate days with each subject testing all 4 types of bread. On each test day subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood samples 5 minutes apart, they ate a portion of one of the breads containing 50g available carbohydrate and had further blood samples at 15, 30, 45, 60,90 and 120 min after starting to eat. After each blood sample also rated their feelings of satiety on a 7-point scale from extremely hungry to extremely full.
- Conditions
- Glycemic Response
- Being tested
- Wholegrain bread, White bread, 15% fiber-rich bread, 30% fiber-rich bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wholegrain breadOther
156.8g wholegrain bread
White breadOther
122.6g white bread
15% fiber-rich breadOther
139.2g bread made with 15% added wheat bran
30% fiber-rich breadOther
166.5g bread made with 30% added wheat bran
| Study group | Role | What they receive |
|---|---|---|
| Wholegrain bread | Other | Not described Receives: Other: Wholegrain bread |
| White bread | Other | Not described Receives: Other: White bread |
| 15% fiber-rich bread | Other | Not described Receives: Other: 15% fiber-rich bread |
| 30% fiber-rich bread | Other | Not described Receives: Other: 30% fiber-rich bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose AUC
Incremental area under the glucose response curve ignoring area below fasting glucose
Measured: 2 hours
Secondary outcomes (2)
Satiety AUC
Incremental area under the satiety response curve
Measured: 2 hours
Hydrolysis index
Incremental area under the hydrolysis curve (amount of glucose released during in-vitro digestion of the breads) expressed as a percentage of that for white bread.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start3 Jun 2014
- Primary completion13 Jun 2014
- Study completion13 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycemic Index Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Guelph, Guelph Research and Development Centre, Agriculture and Agri-Food Canada
- Responsible party
- Sponsor
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, GI Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224806
- Sponsor's protocol ID
- GIL-1426
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fiber Composite-enriched Breads on Glycemic Responses
- ClinicalTrials.gov ID
- NCT03224806
- Acronym / sponsor ID
- GIL-1426
- Conditions
- Glycemic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Glycemic Index Laboratories, IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Guelph, Guelph Research and Development Centre, Agriculture and Agri-Food Canada
- Study start
- 3 Jun 2014 (actual)
- Primary completion
- 13 Jun 2014 (actual)
- Study completion
- 13 Jun 2014 (actual)
- First posted
- 21 Jul 2017 (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.
Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. The present study investigated the effect of enriching white wheat flour with wheat bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were studied on 4 separate days with each subject testing all 4 types of bread. On each test day subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood samples, they ate a portion of one of the breads containing 50g available carbohydrate and had further blood samples at intervals over 2 hours. They also rated their feelings of satiety fasting and at intervals over 2 hours.
Detailed description
Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. The present study investigated the effect of enriching white wheat flour with wheat bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were studied on 4 separate days with each subject testing all 4 types of bread. On each test day subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood samples 5 minutes apart, they ate a portion of one of the breads containing 50g available carbohydrate and had further blood samples at 15, 30, 45, 60,90 and 120 min after starting to eat. After each blood sample also rated their feelings of satiety on a 7-point scale from extremely hungry to extremely full.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wholegrain bread | Other | Other: Wholegrain bread |
| White bread | Other | Other: White bread |
| 15% fiber-rich bread | Other | Other: 15% fiber-rich bread |
| 30% fiber-rich bread | Other | Other: 30% fiber-rich bread |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Good health
Key exclusion criteria (4 listed)
- Known history of AIDS, hepatitis, diabetes or a heart condition
- Use of drugs which would increase risk to the subject or affect the results in the opinion of the medical director
- Any condition which would increase risk to the subject or affect the results in the opinion of the medical director
- Individuals who cannot or will not comply with experimental procedures or do not follow safety guidelines.
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 |
|---|---|---|
| Wholegrain bread156.8g wholegrain bread | Other | Wholegrain bread |
| White bread122.6g white bread | Other | White bread |
| 15% fiber-rich bread139.2g bread made with 15% added wheat bran | Other | 15% fiber-rich bread |
| 30% fiber-rich bread166.5g bread made with 30% added wheat bran | Other | 30% fiber-rich bread |
Primary outcome
Glucose AUC
Time frame: 2 hours
Incremental area under the glucose response curve ignoring area below fasting glucose
2 secondary outcomes
Satiety AUC
Time frame: 2 hours
Hydrolysis index
Time frame: 2 hours
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 21 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Thomas MS Wolever, MD, PhD principal investigator
GI Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wholegrain bread, White bread and 15% fiber-rich bread in people with Glycemic Response, run by Glycemic Index Laboratories, Inc at 1 site in Canada.
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 1 inclusion and 4 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 21 Jul 2017. 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 Canada. 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?
Glucose AUC (time frame: 2 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 21 Jul 2017.