DiabetesNCT01898026
Soluble Fibre Enriched CHO Food Study
A study testing Bread, Mashed Potatoes and Muffins in people with Diabetes and Healthy, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The proposed study will examine the effects of incorporating a soluble fibre blend into commonly consumed refined carbohydrate foods on sensory parameters and postprandial blood glucose. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- What is being tested?
- Bread, Mashed Potatoes and Muffins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Jan 2015
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normotensive (SBP<140mmHg, DBP <90mmHg)
- BMI 18.5 - 25 kg/m2
- Post-menopausal or not pregnant women
Who cannot join
- Allergy or sensitivity to test meals
- Swallowing difficulties
- Chronic use of medications or fibre
- GI conditions affecting stomach pH
- Must not be enrolled in another study
- History of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, celiac /gastrointestinal disease, HIV positive or AIDS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Palatable Soluble Fibre Containing Carbohydrate Foods and Its Effects on Postprandial Blood Glucose Response in Healthy Individuals
The proposed study will examine the effects of incorporating a soluble fibre blend into commonly consumed refined carbohydrate foods on sensory parameters and postprandial blood glucose. A sensory evaluation will be conducted in phase I to asses for differences between the control and fibre enriched samples of white bread, mashed potatoes, muffin, hot breakfast cereal. Phase II will be investigating the postprandial blood glucose responses of the 8 test foods from phase I.
Read the detailed description
Literature to date points to beneficial glycemic effects from consumption of soluble fibre; however, whole grain products consumption is below recommendations possibly due to the presence of unappealing characteristic organoleptic properties. White, refined products are still the choice of the general public. As such, we propose to investigate the feasibility of increasing health benefits of commonly consumed white, refined carbohydrate products by incorporating a soluble fibre blend.
This research is important to determine the feasibility of developing fibre enriched carbohydrate foods that maintains the original organoleptic properties and is effective in reducing postprandial blood glucose response.
35 subjects will be recruited in phase I to complete a sensory evaluation on the test foods. Following tasting of the control and fibre-enriched samples, data on each subjects' liking or disliking will be collected through a 9-point hedonic scale.
An acute crossover RCT will be conducted in phase II by 10 healthy individuals. Subjects will be randomized to consume one the treatments at each visit and blood glucose levels over 120min and satiety scores will be measured.
- Being tested
- Bread, Mashed Potatoes, Muffins, Hot Breakfast Cereal
- Keywords
- PGX, fibre, postprandial glycemia
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreadDietary supplement
Samples of white bread, with or without the addition of PGX fibre blend
Mashed PotatoesDietary supplement
samples of mashed potatoes, with or without the addition of soluble fibre blend
MuffinsDietary supplement
Samples of muffins, with or without the addition of PGX fibre blend
Hot Breakfast CerealDietary supplement
Samples of hot breakfast cereal without the addition of soluble fibre blend
| Study group | Role | What they receive |
|---|---|---|
| PGX | Experimental | samples of white bread, mashed potatoes, muffin, hot breakfast cereal with the addition of soluble fibre blend Receives: Dietary Supplement: Bread; Dietary Supplement: Mashed Potatoes; Dietary Supplement: Muffins; Dietary Supplement: Hot Breakfast Cereal |
| Control | Other | samples of white bread, mashed potatoes, muffin, hot breakfast cereal without the addition of soluble fibre blend Receives: Dietary Supplement: Bread; Dietary Supplement: Mashed Potatoes; Dietary Supplement: Muffins; Dietary Supplement: Hot Breakfast Cereal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Evaluation
Subjects will be recruited in phase I to complete a sensory evaluation on the test foods. Following tasting of the control and fibre-enriched samples, data on each subjects' liking or disliking will be collected through a 9-point hedonic scale.
Measured: 1 month
Postprandial Glycemia
Subjects will be randomized to consume one of the 8 interventions at each visit and blood glucose levels over 120min and satiety scores will be measured.
Measured: 3 months
Secondary outcomes (1)
Satiety Score
The incorporation of viscous soluble fibre in commonly consumed carbohydrate foods will result in increase in subjective satiety compared to non soluble fibre enriched products. Satiety will be measured using a satiety questionnaire in which you will answer four questions about how full you feel.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Vuksan, Unity Health Toronto
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, St. Michael's & University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898026
- Sponsor's protocol ID
- White Line
- Other IDs
- 12-379C
- Status last verified
- Feb 2014
- First submitted
- 9 Jul 2013
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Palatable Soluble Fibre Containing Carbohydrate Foods and Its Effects on Postprandial Blood Glucose Response in Healthy Individuals
- ClinicalTrials.gov ID
- NCT01898026
- Acronym / sponsor ID
- White Line
- Keywords
- PGX, fibre, postprandial glycemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 12 Jul 2013 (estimated)
- 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.
The proposed study will examine the effects of incorporating a soluble fibre blend into commonly consumed refined carbohydrate foods on sensory parameters and postprandial blood glucose. A sensory evaluation will be conducted in phase I to asses for differences between the control and fibre enriched samples of white bread, mashed potatoes, muffin, hot breakfast cereal. Phase II will be investigating the postprandial blood glucose responses of the 8 test foods from phase I.
Detailed description
Literature to date points to beneficial glycemic effects from consumption of soluble fibre; however, whole grain products consumption is below recommendations possibly due to the presence of unappealing characteristic organoleptic properties. White, refined products are still the choice of the general public. As such, we propose to investigate the feasibility of increasing health benefits of commonly consumed white, refined carbohydrate products by incorporating a soluble fibre blend.
This research is important to determine the feasibility of developing fibre enriched carbohydrate foods that maintains the original organoleptic properties and is effective in reducing postprandial blood glucose response.
35 subjects will be recruited in phase I to complete a sensory evaluation on the test foods. Following tasting of the control and fibre-enriched samples, data on each subjects' liking or disliking will be collected through a 9-point hedonic scale.
An acute crossover RCT will be conducted in phase II by 10 healthy individuals. Subjects will be randomized to consume one the treatments at each visit and blood glucose levels over 120min and satiety scores will be measured.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGX | Experimental | Dietary Supplement: Bread, Dietary Supplement: Mashed Potatoes, Dietary Supplement: Muffins, Dietary Supplement: Hot Breakfast Cerealsamples of white bread, mashed potatoes, muffin, hot breakfast cereal with the addition of soluble fibre blend |
| Control | Other | Dietary Supplement: Bread, Dietary Supplement: Mashed Potatoes, Dietary Supplement: Muffins, Dietary Supplement: Hot Breakfast Cerealsamples of white bread, mashed potatoes, muffin, hot breakfast cereal without the addition of soluble fibre blend |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normotensive (SBP<140mmHg, DBP <90mmHg)
- BMI 18.5 - 25 kg/m2
- Post-menopausal or not pregnant women
Key exclusion criteria (6 listed)
- Allergy or sensitivity to test meals
- Swallowing difficulties
- Chronic use of medications or fibre
- GI conditions affecting stomach pH
- Must not be enrolled in another study
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 |
|---|---|---|
| BreadSamples of white bread, with or without the addition of PGX fibre blend | Dietary supplement | Control, PGX |
| Mashed Potatoessamples of mashed potatoes, with or without the addition of soluble fibre blend | Dietary supplement | Control, PGX |
| MuffinsSamples of muffins, with or without the addition of PGX fibre blend | Dietary supplement | Control, PGX |
| Hot Breakfast CerealSamples of hot breakfast cereal without the addition of soluble fibre blend | Dietary supplement | Control, PGX |
Primary outcome
Sensory Evaluation
Time frame: 1 month
Subjects will be recruited in phase I to complete a sensory evaluation on the test foods. Following tasting of the control and fibre-enriched samples, data on each subjects' liking or disliking will be collected through a 9-point hedonic scale.
Postprandial Glycemia
Time frame: 3 months
Subjects will be randomized to consume one of the 8 interventions at each visit and blood glucose levels over 120min and satiety scores will be measured.
1 secondary outcome
Satiety Score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
Related trials for Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
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.
Vladimir Vuksan, PhD principal investigator
St. Michael's & University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bread, Mashed Potatoes and Muffins in people with Diabetes and Healthy, run by Unity Health Toronto 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Feb 2014. 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?
Results are not available in the source record.
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?
Sensory Evaluation (time frame: 1 month). The study lists 2 primary outcomes in all. 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 5 Feb 2014.