A Randomized, Single-blind, Crossover Study to Evaluate Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products

Aventure AB1 site in 1 country20 target enrollmentOctober 4, 2018

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Aventure AB
Enrollment: 20
Locations: 1
Primary Endpoint: Postprandial glycaemia capillary
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to investigate the effect on postprandial glycaemia in a healthy population after intake of milk and oat based products.

Detailed Description

Postprandial glycaemia, insulinaemia and GLP-1 will be measured after intake of test meals with equal amount of carbohydrates (adjusted using bread) and equal amount of total water.

Registry

clinicaltrials.gov

Start Date

October 4, 2018

End Date

March 5, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Aventure AB

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female 20 to 40 years of age
•BMI 20-27 (±0.5) kg/m²
•Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
•Healthy as determined by medical history and information provided by the volunteer
•Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits
•Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria

•Elevated fasting blood glucose (at or above 6.1 mmol/L at fasting on visit 2, 3, 4 or 5)
•Elevated fasting insulin (above 25 mIE/L)
•Women who are pregnant or breast feeding
•Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the SI
•Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the SI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician.
•Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
•Use of antibiotics within 2 weeks of enrollment
•Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
•Allergy to ingredients included in investigational product, placebo or standardized meal
•Participants restricted to a vegetarian or vegan diet

Outcomes

Primary Outcomes

Postprandial glycaemia capillary

Time Frame: 0-120 min after consumption

Primary outcome is the difference in the two-hour incremental area under the curve (iAUC (0 - 120 min)) for capillary blood glucose between product 1-4 and the bread reference.