Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables

Study Overview
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Brief Summary
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The overall goal is to increase the knowledge that 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 of this project is to evaluate effects in healthy humans on acute postprandial glucose regulation of plant based lipids. Due to the tight connection between cardiometabolic health and cognitive functions, a secondary issue is to investigate effects of test foods on cognitive test variables and mood parameters.

Official Title
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Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic- and Cognitive Test Variables

Conditions
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Diabete Type 2, Obesity

Intervention / Treatment
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* Dietary Supplement: lipids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparently healthy subjects Between 20 and 40 years old Body mass index between 19-28 kg / m2), Consuming a non-vegetarian diet generally in line with the Nordic nutrition recommendations. Exclusion Criteria: Fasting blood glucose concentration >6.1 mmol/L Known metabolic or gastrointestinal disorder (eg diabetes, high cholesterol, high blood pressure, IBS), or other disease that may affect the study results. Regular medication, except for long-term and stable medication for the lack or reduced production of thyroid hormone (eg Levaxin). Antibiotics or probiotics for at least four weeks before the start of the study, The use of tobacco products

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 |
| --- | --- |
| Other: WWB Reference<br>White wheat bread (WWB) without lipid supplements. The effects of this high glycaemic product on postprandial glucose and insulin responses are well studied. | Dietary Supplement: lipids<br>* Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.<br>|
| Experimental: WWB 5g active lipids<br>WWB supplemented with 5 g active lipids, and 10 g control lipids | Dietary Supplement: lipids<br>* Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.<br>|
| Experimental: WWB 10g active lipids<br>WWB supplemented with 10g active lipids, and 5 g control lipids | Dietary Supplement: lipids<br>* Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.<br>|
| Experimental: WWB 15g active lipids<br>WWB supplemented with 15g active lipids, and 0 g control lipids | Dietary Supplement: lipids<br>* Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.<br>|
| Active Comparator: WWB 15 g control lipids<br>WWB supplemented with 15g control lipids | Dietary Supplement: lipids<br>* Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose tolerance | Postprandial blood glucose responses | 3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin responses | Postprandial insulin responses | 3 hours. Fasting (time =0 minutes), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes | 
| Mood variables | Registration of subjective mood ratings (valence and activity) on 0-100 mm Visual Analogue Scales (VAS) at fasting and thereafter every hour until 180 min. Extremes of the sensations of the variables is at the two ends of the scales, i.e. 0 mm relates to the extrem of low senations sensations and 100 mm correspond to the highest sensation of the variables. | 60 minutes after start of test product, after 120 minutes and after 180 minutes | 
| Appetite sensations | Subjective sensations of hunger, satiety, and desire to eat are registered on 0-100 mm VAS scales. Extremes of the sensations of the variables is at the two ends of the scales, i.e. 0 mm relates to the extrem of low senations sensations and 100 mm correspond to the highest sensation of the variables. | 3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes |