- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03722641
Evaluation of Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products
July 2, 2019 updated by: Aventure AB
A Randomized, Single-blind, Crossover Study to Evaluate Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lund, Sweden
- Aventure AB
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
- Intolerance to lactose or gluten
- Individuals who are averse to venous catheterization or capillary blood sampling
- Currently active smokers (or using other tobacco products, and e-cigarettes)
- Unstable medical conditions as determined by SI
- Participation in other clinical research trials
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Acute infection
- Any other condition which in the SI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Bread reference
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.
|
Commercially available white wheat bread
Developed reference product based on milk
Developed product based on full fat milk with addition of oat
Developed product based on skim milk with addition of oat giving a high fiber content to the product
Developed product based on skim milk with addition of oat giving a lower fiber content to the product
|
Experimental: Product 1: Milk
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk.
|
Commercially available white wheat bread
Developed reference product based on milk
Developed product based on full fat milk with addition of oat
Developed product based on skim milk with addition of oat giving a high fiber content to the product
Developed product based on skim milk with addition of oat giving a lower fiber content to the product
|
Experimental: Product 2: Full fat milk + oat
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on full fat milk and oat with high fiber content.
|
Commercially available white wheat bread
Developed reference product based on milk
Developed product based on full fat milk with addition of oat
Developed product based on skim milk with addition of oat giving a high fiber content to the product
Developed product based on skim milk with addition of oat giving a lower fiber content to the product
|
Experimental: Product 3: Skim milk + oat, high fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with high fiber content.
|
Commercially available white wheat bread
Developed reference product based on milk
Developed product based on full fat milk with addition of oat
Developed product based on skim milk with addition of oat giving a high fiber content to the product
Developed product based on skim milk with addition of oat giving a lower fiber content to the product
|
Experimental: Product 4: Skim milk + oat, low fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with low fiber content.
|
Commercially available white wheat bread
Developed reference product based on milk
Developed product based on full fat milk with addition of oat
Developed product based on skim milk with addition of oat giving a high fiber content to the product
Developed product based on skim milk with addition of oat giving a lower fiber content to the product
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0-120 min after consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial glycaemia intravenous
Time Frame: 0-120 min
|
The difference in the two-hour iAUC (0 - 120 min) for intravenous blood glucose between product 1-4 and the bread reference.
|
0-120 min
|
Postprandial Cmax capillary glucose
Time Frame: 0-180 min
|
The difference in the three-hour Cmax (0 - 180 min) of capillary blood glucose between product 1-4 and the bread reference.
|
0-180 min
|
Postprandial Cmax venous glucose
Time Frame: 0-180 min
|
The difference in the three-hour Cmax (0 - 180 min) of intravenous blood glucose between product 1-4 and the bread reference.
|
0-180 min
|
Postprandial glycaemia capillary
Time Frame: 0-180 min
|
The difference in the three-hour iAUC (0 - 180 min) of capillary blood glucose between product 1-4 and the bread reference.
|
0-180 min
|
Postprandial glycaemia venous
Time Frame: 0-180 min
|
The difference in the three-hour iAUC (0 - 180 min) of intravenous blood glucose between product 1-4 and the bread reference.
|
0-180 min
|
Postprandial glycaemia capillary
Time Frame: 0-60 min
|
The difference in the one-hour iAUC (0 - 60 min) of capillary blood glucose between product 1-4 and the bread reference.
|
0-60 min
|
Postprandial glycaemia venous
Time Frame: 0-60 min
|
The difference in the one-hour iAUC (0 - 60 min) of intravenous blood glucose between product 1-4 and the bread reference.
|
0-60 min
|
Postprandial glycaemia Tmax capillary
Time Frame: 0-180 min
|
The difference in the Tmax (the time to maximum concentration) of capillary blood glucose between product 1-4 and the bread reference.
|
0-180 min
|
Postprandial glycaemia Tmax venous
Time Frame: 0-180 min
|
The difference in the Tmax of intravenous blood glucose between product 1-4 and the bread reference.
|
0-180 min
|
Postprandial insulinaemia
Time Frame: 0-180 min
|
The difference in the three-hour iAUC (0 - 180 min) of intravenous blood insulin between product 1-4 and the bread reference.
|
0-180 min
|
Postprandial insulinaemia
Time Frame: 0-120 min
|
The difference in the two-hour iAUC (0 - 120 min) of intravenous blood insulin between product 1-4 and the bread reference.
|
0-120 min
|
Postprandial insulinaemia
Time Frame: 0-60 min
|
The difference in the one-hour iAUC (0 - 60 min) of intravenous blood insulin between product 1-4 and the bread reference.
|
0-60 min
|
Postprandial insulinaemia Cmax
Time Frame: 0-180 min
|
The difference in the three-hour Cmax (0 - 180 min) of intravenous blood insulin between product 1-4 and the bread reference.
|
0-180 min
|
Postprandial insulinaemia Tmax
Time Frame: 0-180 min
|
The difference in the Tmax of intravenous blood insulin between product 1-4 and the bread reference.
|
0-180 min
|
Postprandial GLP-1 bread reference
Time Frame: 0-60 min
|
The difference in the one-hour iAUC (0 - 60 min) of intravenous blood GLP-1 between product 1-4 and the bread reference.
|
0-60 min
|
Postprandial GLP-1, yoghurt control
Time Frame: 0-60 min
|
The difference in the one-hour iAUC (0 - 60 min) of intravenous blood GLP-1 between products 2-4 and product 1.
|
0-60 min
|
Postprandial GLP-1 Cmax bread reference
Time Frame: 0-60 min
|
The difference in the one-hour Cmax (0 - 60 min) of intravenous blood GLP-1 between product 1-4 and the bread reference.
|
0-60 min
|
Postprandial GLP-1 Cmax yoghurt control
Time Frame: 0-60 min
|
The difference in the one-hour Cmax (0 - 60 min) of intravenous blood GLP-1 between products 2-4 and product 1.
|
0-60 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2018
Primary Completion (Actual)
March 5, 2019
Study Completion (Actual)
March 5, 2019
Study Registration Dates
First Submitted
October 24, 2018
First Submitted That Met QC Criteria
October 25, 2018
First Posted (Actual)
October 29, 2018
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 2, 2019
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- TR1801
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Bread reference
-
Agricultural University of AthensCompletedAppetitive Behavior | Potential Abnormality of Glucose ToleranceGreece
-
Nutrition Institute, SloveniaValens Int. d.o.o., SlovenijaCompleted
-
Agricultural University of AthensCompletedAppetitive Behavior | Potential Abnormality of Glucose ToleranceGreece
-
Agricultural University of AthensCompletedAppetitive Behavior | Potential Abnormality of Glucose ToleranceGreece
-
Nutrition Institute, SloveniaSlovenian Research Agency; Valens Int. d.o.o., Slovenija; Community Health Centre...CompletedGlycemic IndexSlovenia
-
Glycemic Index Laboratories, IncUniversity of Guelph; Guelph Research and Development Centre, Agriculture and...Completed
-
KU LeuvenRecruitingAppetite Regulation | Energy IntakeBelgium
-
Newcastle-upon-Tyne Hospitals NHS TrustBiotechnology and Biological Sciences Research CouncilCompleted
-
Paulic Meunerie SAInstitut Polytechnique UniLaSalleCompleted
-
University of Eastern FinlandVTT Technical Research Centre of FinlandCompletedGlucose Metabolism Disorders | Inflammation | Intestinal Disorder