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Completed

NCT Number: NCT02651597

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, R3T 6C5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oatmeal

Other

Primary outcomes

  1. Blood Glucose

    Time frame: 0-200 mins

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

Secondary outcomes

  1. Appetite (visual analogue scales)

    Time frame: 0-200 mins

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

  2. Physical Comfort

    Time frame: 0-200 mins

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

  3. Energy/Fatigue

    Time frame: 0-200mins

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

  4. Palatability

    Time frame: at 5 mins

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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • PepsiCo Global R&D

Registry information

Official study title

A Randomized, Controlled, Cross-over Study of the Effect of Oats on Post Prandial Glucose Response

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 11, 2016
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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