NCT01898026

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 5, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

July 9, 2013

Last Update Submit

February 4, 2014

Conditions

DiabetesHealthy

Keywords

PGXfibrepostprandial glycemia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Satiety Score

    3 months

Other Outcomes (1)

  • Safety

    3 montsh

Study Arms (2)

PGX

EXPERIMENTAL

samples of white bread, mashed potatoes, muffin, hot breakfast cereal with the addition of soluble fibre blend

Dietary Supplement: BreadDietary Supplement: Mashed PotatoesDietary Supplement: MuffinsDietary Supplement: Hot Breakfast Cereal

Control

OTHER

samples of white bread, mashed potatoes, muffin, hot breakfast cereal without the addition of soluble fibre blend

Dietary Supplement: BreadDietary Supplement: Mashed PotatoesDietary Supplement: MuffinsDietary Supplement: Hot Breakfast Cereal

Interventions

BreadDIETARY_SUPPLEMENT

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

ControlPGX
Mashed PotatoesDIETARY_SUPPLEMENT

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

ControlPGX
MuffinsDIETARY_SUPPLEMENT

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

ControlPGX
Hot Breakfast CerealDIETARY_SUPPLEMENT

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

ControlPGX

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's

Toronto, Ontario, M5BW8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Bread

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Vladimir Vuksan, PhD

    St. Michael's & University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 12, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2014

Study Completion

January 1, 2015

Last Updated

February 5, 2014

Record last verified: 2014-02

Locations

CA(1)