NCT02651597

Brief Summary

The objectives are to assess the effects of high viscosity vs. medium and low viscosity oat β-glucan on post-prandial glycemic response in healthy adult participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2016

Completed
Last Updated

January 23, 2023

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

January 6, 2016

Last Update Submit

January 19, 2023

Conditions

NormoglycemicNormal Body Weight

Keywords

OatmealBeta glucanPostprandial Glycemic ResponseBlood Glucose

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose

    Total area under the curve (iAUC, mmol\*min/L) for glucose

    0-200 mins

Secondary Outcomes (4)

  • Appetite (visual analogue scales)

    0-200 mins

  • Physical Comfort

    0-200 mins

  • Energy/Fatigue

    0-200mins

  • Palatability

    at 5 mins

Study Arms (3)

Low Viscous

EXPERIMENTAL

Low Viscous Beta Glucan Oatmeal

Other: Oatmeal

Medium Viscous

EXPERIMENTAL

Medium Viscous Beta Glucan Oatmeal

Other: Oatmeal

High Viscous

EXPERIMENTAL

High Viscous Beta Glucan Oatmeal

Other: Oatmeal

Interventions

OatmealOTHER
High ViscousLow ViscousMedium Viscous

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normoglycemic (\<5.6 mmol/L)
  • BMI= 18.5-29.9 kg/m²

You may not qualify if:

  • A change in medication (dose or type) or medical event requiring hospitalization within the past month.
  • Daily tobacco use.
  • Eat meals at irregular or unusual times.
  • Food allergy, aversion or unwillingness to eat study foods.
  • Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect blood sugar.
  • Presence of a gastrointestinal disorder.
  • Currently pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, R3T 6C5, Canada

Location

Study Officials

  • Peter Jones, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 11, 2016

Study Start

April 1, 2016

Primary Completion

December 10, 2016

Study Completion

December 10, 2016

Last Updated

January 23, 2023

Record last verified: 2021-04

Locations

CA(1)