A Study of the Effect of Oats on Post Prandial Glucose Response

Sponsor
University of Manitoba (Other)
Overall Status
Completed
CT.gov ID
NCT02651597
Collaborator
PepsiCo Global R&D (Industry)
24
1
3
8.3
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Oatmeal
N/A

Detailed Description

The trial will be a 3 week double-blinded, randomized, cross-over design with 3 treatment intervention (oatmeal breakfasts costain low, medium and high viscosity of beta glucan) periods separated by about 5-7 days washout period. Normoglycemic (<5.6 mmol/L) males and females (12 of each) of age 18-45 y with a body mass index (BMI) of 18.5-29.9 kg/m2 will be recruited.

Each participant will receive each of the following breakfast foods in a random order: 1) oat meal containing low viscosity beta glucan; 2) oat meal containing medium viscosity beta glucan; 3) oat meal containing high viscosity beta glucan. The participants will be asked to consume one of the breakfast foods during each visit.

Following each blood sample, appetite, physical comfort, energy/fatigue, and palatability of treatments will be measured by visual analogue scales (VAS).

Glucose measurements: Capillary blood will be collected during each visit by finger prick. Blood will be collected at fasting and at 15, 30, 45, 60, 90 and 120 minutes after the first bite/sip of the test product according to the Clinical Laboratory Standard Institute (CLSI) guidelines. Blood glucose will be measured in finger prick blood samples by glucose meters .

Males will be scheduled for three sessions over 3 weeks. Women will be scheduled during the first two weeks of their menstrual cycle (follicular phase), once per week.

During the wash-out days (5 - 7 days between each phase), participants can go about their daily activities unrestricted with the following exception: no strenuous activity or alcohol consumption on the days before the clinic visit. The investigators will ask that participants go to sleep at the same time on the days before the sessions.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
A Randomized, Controlled, Cross-over Study of the Effect of Oats on Post Prandial Glucose Response
Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Dec 10, 2016
Actual Study Completion Date :
Dec 10, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low Viscous

Low Viscous Beta Glucan Oatmeal

Other: Oatmeal

Experimental: Medium Viscous

Medium Viscous Beta Glucan Oatmeal

Other: Oatmeal

Experimental: High Viscous

High Viscous Beta Glucan Oatmeal

Other: Oatmeal

Outcome Measures

Primary Outcome Measures

  1. Blood Glucose [0-200 mins]

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

Secondary Outcome Measures

  1. Appetite (visual analogue scales) [0-200 mins]

    Measured by VAS questionnaire at 12 time points used to calculate area under curve

  2. Physical Comfort [0-200 mins]

    Measured by VAS questionnaire at 12 time points used to calculate area under curve

  3. Energy/Fatigue [0-200mins]

    Measured by VAS questionnaire at 12 time points used to calculate area under curve

  4. Palatability [at 5 mins]

    Measured by VAS questionnaire at 12 time points used to calculate area under curve

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Normoglycemic (<5.6 mmol/L)

  • BMI= 18.5-29.9 kg/m²

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba Winnipeg Manitoba Canada R3T 6C5

Sponsors and Collaborators

  • University of Manitoba
  • PepsiCo Global R&D

Investigators

  • Principal Investigator: Peter Jones, PhD, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT02651597
Other Study ID Numbers:
  • B2015:142
First Posted:
Jan 11, 2016
Last Update Posted:
Nov 16, 2018
Last Verified:
Nov 1, 2018
Keywords provided by University of Manitoba
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2018