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Soluble Fibre Enriched CHO Food Study

Development of Palatable Soluble Fibre Containing Carbohydrate Foods and Its Effects on Postprandial Blood Glucose Response in Healthy Individuals

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01898026
Enrollment
35
Registered
2013-07-12
Start date
2013-07-31
Completion date
2015-01-31
Last updated
2014-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Keywords

PGX, fibre, postprandial glycemia

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTBread

Samples of white bread, with or without the addition of PGX fibre blend

DIETARY_SUPPLEMENTMashed Potatoes

samples of mashed potatoes, with or without the addition of soluble fibre blend

DIETARY_SUPPLEMENTMuffins

Samples of muffins, with or without the addition of PGX fibre blend

DIETARY_SUPPLEMENTHot Breakfast Cereal

Samples of hot breakfast cereal without the addition of soluble fibre blend

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Normotensive (SBP\<140mmHg, DBP \<90mmHg) * BMI 18.5 - 25 kg/m2 * Post-menopausal or not pregnant women

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Sensory Evaluation1 monthSubjects 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 Glycemia3 monthsSubjects 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.

Secondary

MeasureTime frameDescription
Satiety Score3 monthsThe 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.

Other

MeasureTime frameDescription
Safety3 montshSafety will monitored using a symptoms questionnaire.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026