Effects of Plant-based Polar Lipids on Acute and Second Meal Glucose Tolerance and Appetite Sensations

Study Overview
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Brief Summary
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The overall goal of the project is to increase knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose is to evaluate effects on cardiometabolic test markers of bioactive compounds in healthy humans. Previously the investigators reported beneficial effects of oat polar lipids on cardiometabolic risk markers. In this study the effects previously observed will be compared with cardiometabolic effects of another plant based lipid.

Official Title
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Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables

Conditions
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Diet Intervention, Healthy Subjects

Intervention / Treatment
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* Other: Non-polar lipids
* Other: No lipids
* Dietary Supplement: Polar lipids low
* Dietary Supplement: Polar lipids high


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparently healthy men and women non-smokers between 20-40 years of age BMI between 18,5-30 kg/m2 No known metabolic disorders or food allergies. The test subjects should follow a normal diet in accordance with the Nordic Nutrition Recommendations. Exclusion Criteria: Fasting blood glucose ≥6.1 mmol/L Use of antibiotics or probiotics in the last three months or during the study period. Smoking Blood donation during the last two months and during the study. Food allergies or food intolerances CVD Metabolic diseases Inflammatory bowel diseases.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, controlled, crossover trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Non-polar lipids<br>A food product containing 15 g plant-based non-polar lipids. The fat is consumed blended with a carbohydrate source containing 50 g available carbohydrates. | Other: Non-polar lipids<br>* The shame comparator lipid intervention product contains no polar lipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of lipids are15g, and the total amounts of available carbohydrates are 50 g.<br>|
| Placebo Comparator: No Lipids<br>Reference product. A carbohydrate source containing 50 g available carbohydrates. | Other: No lipids<br>* The placebo comparator contains no added lipids. The product contains a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of available carbohydrates are 50 g.<br>|
| Experimental: Polar Lipids low<br>A food product containing 15 g plant-based lipids, of which 50% is polar lipids and 50% is non-polar lipids.The fat is consumed blended with a carbohydrate source containing 50 g available carbohydrates. | Dietary Supplement: Polar lipids low<br>* The experimental intervention product contains 7,5 g plant based lipids polar lipids and 7.5 g plant based lipids non polarlipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. TThe total amounts of available carbohydrates are 50 g.<br>|
| Experimental: Polar Lipids high<br>A food product containing 15 g plant-based lipids, of which 100 % is polar lipids. The fat is consumed blended with a carbohydrate source containing 50 g available carbohydrates. | Dietary Supplement: Polar lipids high<br>* The experimental intervention product contains15 g plant based polar lipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of available carbohydrates are 50 g.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose concentration (glucose tolerance) | Test products will be consumed at breakfast. Blood glucose will be determined repeatedly after the breakfast and also following a standardised lunch. The primary outcome measures are incremental areas under the curve after the test breakfast and after the standardised lunch | 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective hunger sensations | Test products will be consumed at breakfast. Subjective appetite variables will be determined repeatedly after the breakfast and also following a standardised lunch. The secondary outcome measures are areas under the curve after the test breakfast and after the standardised lunch. Subjective appetite variables will be determined using a 100 mm Visual Analogue Scale (VAS). | 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes. | 
| Subjective satiety sensations | Test products will be consumed at breakfast. Subjective appetite variables will be determined repeatedly after the breakfast and also following a standardised lunch. The secondary outcome measures are areas under the curve after the test breakfast and after the standardised lunch. Subjective appetite variables will be determined using a 100 mm Visual Analogue Scale (VAS). | 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes. | 
| Subjective sensations of desire to eat | Test products will be consumed at breakfast. Subjective appetite variables will be determined repeatedly after the breakfast and also following a standardised lunch. The secondary outcome measures are areas under the curve after the test breakfast and after the standardised lunch. Subjective appetite variables will be determined using a 100 mm Visual Analogue Scale (VAS). | 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes. |