Soluble Fibre Enriched CHO Food Study

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Bread
* Dietary Supplement: Mashed Potatoes
* Dietary Supplement: Muffins
* Dietary Supplement: Hot Breakfast Cereal


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PGX<br>samples of white bread, mashed potatoes, muffin, hot breakfast cereal with the addition of soluble fibre blend | Dietary Supplement: Bread<br>* Samples of white bread, with or without the addition of PGX fibre blend<br>Dietary Supplement: Mashed Potatoes<br>* samples of mashed potatoes, with or without the addition of soluble fibre blend<br>Dietary Supplement: Muffins<br>* Samples of muffins, with or without the addition of PGX fibre blend<br>Dietary Supplement: Hot Breakfast Cereal<br>* Samples of hot breakfast cereal without the addition of soluble fibre blend<br>|
| Other: Control<br>samples of white bread, mashed potatoes, muffin, hot breakfast cereal without the addition of soluble fibre blend | Dietary Supplement: Bread<br>* Samples of white bread, with or without the addition of PGX fibre blend<br>Dietary Supplement: Mashed Potatoes<br>* samples of mashed potatoes, with or without the addition of soluble fibre blend<br>Dietary Supplement: Muffins<br>* Samples of muffins, with or without the addition of PGX fibre blend<br>Dietary Supplement: Hot Breakfast Cereal<br>* Samples of hot breakfast cereal without the addition of soluble fibre blend<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PGX, fibre, postprandial glycemia