Overview

This trial is active, not recruiting.

Conditions diabetes, healthy
Treatments bread, mashed potatoes, muffins, hot breakfast cereal
Sponsor St. Michael's Hospital, Toronto
Start date July 2013
End date July 2014
Trial size 35 participants
Trial identifier NCT01898026, 12-379C, White Line

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Arm
(Experimental)
samples of white bread, mashed potatoes, muffin, hot breakfast cereal with the addition of soluble fibre blend
bread
Samples of white bread, with or without the addition of PGX fibre blend
mashed potatoes
samples of mashed potatoes, with or without the addition of soluble fibre blend
muffins
Samples of muffins, with or without the addition of PGX fibre blend
hot breakfast cereal
Samples of hot breakfast cereal without the addition of soluble fibre blend
(Other)
samples of white bread, mashed potatoes, muffin, hot breakfast cereal without the addition of soluble fibre blend
bread
Samples of white bread, with or without the addition of PGX fibre blend
mashed potatoes
samples of mashed potatoes, with or without the addition of soluble fibre blend
muffins
Samples of muffins, with or without the addition of PGX fibre blend
hot breakfast cereal
Samples of hot breakfast cereal without the addition of soluble fibre blend

Primary Outcomes

Measure
Sensory Evaluation
time frame: 1 month
Postprandial Glycemia
time frame: 3 months

Secondary Outcomes

Measure
Satiety Score
time frame: 3 months

Eligibility Criteria

Male or female participants from 19 years up to 75 years old.

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

Additional Information

Official title Development of Palatable Soluble Fibre Containing Carbohydrate Foods and Its Effects on Postprandial Blood Glucose Response in Healthy Individuals
Principal investigator Vladimir Vuksan, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by St. Michael's Hospital, Toronto.