Clinical trial NCT03722641: Evaluation of Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products
Official title: A Randomized, Single-blind, Crossover Study to Evaluate Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Aventure AB
Sponsor class: INDUSTRY
First posted: 2018-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Elevated fasting blood glucose (at or above 6.1 mmol/L at fasting on visit 2, 3, 4 or 5)
2. Elevated fasting insulin (above 25 mIE/L)
3. Women who are pregnant or breast feeding
4. Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the SI
5. 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.
6. Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
7. Use of antibiotics within 2 weeks of enrollment
8. Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
9. Allergy to ingredients included in investigational product, placebo or standardized meal
10. Participants restricted to a vegetarian or vegan diet
11. Intolerance to lactose or gluten
12. Individuals who are averse to venous catheterization or capillary blood sampling
13. Currently active smokers (or using other tobacco products, and e-cigarettes)
14. Unstable medical conditions as determined by SI
15. Participation in other clinical research trials
16. Individuals who are cognitively impaired and/or who are unable to give informed consent
17. Acute infection
18. 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

Primary outcomes:
measure: Postprandial glycaemia capillary
timeFrame: 0-120 min after consumption
Secondary outcomes:
measure: Postprandial glycaemia intravenous
timeFrame: 0-120 min
measure: Postprandial Cmax capillary glucose
timeFrame: 0-180 min
measure: Postprandial Cmax venous glucose
timeFrame: 0-180 min
measure: Postprandial glycaemia capillary
timeFrame: 0-180 min
measure: Postprandial glycaemia venous
timeFrame: 0-180 min
measure: Postprandial glycaemia capillary
timeFrame: 0-60 min
measure: Postprandial glycaemia venous
timeFrame: 0-60 min
measure: Postprandial glycaemia Tmax capillary
timeFrame: 0-180 min
measure: Postprandial glycaemia Tmax venous
timeFrame: 0-180 min
measure: Postprandial insulinaemia
timeFrame: 0-180 min
measure: Postprandial insulinaemia
timeFrame: 0-120 min
measure: Postprandial insulinaemia
timeFrame: 0-60 min
measure: Postprandial insulinaemia Cmax
timeFrame: 0-180 min
measure: Postprandial insulinaemia Tmax
timeFrame: 0-180 min
measure: Postprandial GLP-1 bread reference
timeFrame: 0-60 min
measure: Postprandial GLP-1, yoghurt control
timeFrame: 0-60 min
measure: Postprandial GLP-1 Cmax bread reference
timeFrame: 0-60 min
measure: Postprandial GLP-1 Cmax yoghurt control
timeFrame: 0-60 min
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Aventure AB
Study officials:
References: