Soluble Fibre Enriched CHO Food Study

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01898026
• Other study ID #: White Line
• Secondary ID: 12-379C
• Status: Active, not recruiting
• Phase: N/A
• First received: July 9, 2013
• Last updated: February 4, 2014
• Start date: July 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2014
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: January 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Canada	St. Michael's	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	Safety will monitored using a symptoms questionnaire.	3 montsh	No
Primary	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	No
Primary	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	No
Secondary	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	No