Effects of Plant Polar Lipids on Glucose Tolerance

Study Overview
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Brief Summary
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In this randomized controlled trial, two different plant polar lipids are investigated with respect to their potential to affect acute and second meal glucose tolerance and appetite sensations. The effects are compared with a common non-polar commercial oil. The lipids are consumed spread on a white wheat bread. A white wheat bread without added lipids is included as a control product. The test products are consumed at breakfast, and test variables are investigated in the postprandial period after the test breakfast and also after a second meal standard lunch.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Polar lipid 1
* Dietary Supplement: Polar lipid 2
* Dietary Supplement: Non-polar lipids
* Other: No lipids


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 Cardiovascular diseases 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polar lipid 1<br>15 g Plant polar lip 1 consumed with a white wheat bread including 50 g available carbohydrates | Dietary Supplement: Polar lipid 1<br>* 15g plant polar lipids from plant source 1. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).<br>|
| Experimental: Polar lipid 2<br>15 g Plant polar lipids 2 consumed with a white wheat bread including 50 g available carbohydrates | Dietary Supplement: Polar lipid 2<br>* 15g plant polar lipids from plant source 2. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).<br>|
| Active Comparator: non-polar lipids<br>15 g commonly consumed non-polar lipids consumed with a white wheat bread including 50 g available carbohydrates | Dietary Supplement: Non-polar lipids<br>* 15g non-polar plant lipids from plant source 1. The lipids supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).<br>|
| Placebo Comparator: no lipids<br>A white wheat bread including 50 g available carbohydrates | Other: No lipids<br>* A commercial white wheat flour bread as a source of available carbohydrates (50 g), without added lipids.<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 for glucose concentrations 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 |
| --- | --- | --- |
| Serum insulin concentrations | Test products will be consumed at breakfast. Insulin will be determined repeatedly after the breakfast and also following a standardised lunch. The primary outcome measures for insulin are incremental areas under the curve after the test breakfast and after the standardised lunch | 5.5 hours. Fasting (time =0), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes. | 
| 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. |