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

U

University of Manitoba

Status

Completed

Conditions

Normoglycemic
Normal Body Weight

Treatments

Other: Oatmeal

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02651597
B2015:142

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

24 participants in 3 patient groups

Low Viscous
Experimental group
Description:
Low Viscous Beta Glucan Oatmeal
Treatment:
Other: Oatmeal
Medium Viscous
Experimental group
Description:
Medium Viscous Beta Glucan Oatmeal
Treatment:
Other: Oatmeal
High Viscous
Experimental group
Description:
High Viscous Beta Glucan Oatmeal
Treatment:
Other: Oatmeal

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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