Designing Biofunctional Dairy Foods: Matrix Structure of Dairy Products in Relation to Lipaemia

Study Overview
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Brief Summary
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The overall aim of this study is to investigate how dairy products with different structures and textures affect lipid absorption kinetics in the acute postprandial period via blood lipid biochemistry. The study will be conducted as a randomized acute cross-over meal study. Apparently healthy men will be recruited in the study. They will on 4 test days consume the 4 dairy products and blood will be drawn the following 8 hours.

Detailed Description
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The overall aim of this study is to investigate how dairy products with similar nutrient content but different structures and textures affect lipid absorption kinetics in the acute postprandial period via blood lipid biochemistry, as well as nuclear magnetic resonance (NMR) and liquid chromatography mass spectrometry (LCMS)-based metabolomics. The study will be conducted as a randomized acute cross-over meal study. On four different test days (with a minimum of 2 weeks washout period) four dairy products with similar nutrient composition but different structures or textures will be tested. During each meal test a single dairy product (+ bread and water) is served and postprandial blood samples are collected the following 8 hours. Subjective appetite measurements (VAS) are filled in during the 8-hour period and an ad libitum meal is served in the end of the day. 25 apparently healthy men (weight stable, 18-40 years, 18.5-24.9 kg/m2) will be recruited.

Official Title
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Designing Biofunctional Dairy Foods: Matrix Structure of Dairy Products in Relation to Lipaemia

Conditions
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Lipaemia

Intervention / Treatment
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* Dietary Supplement: Cheddar cheese
* Dietary Supplement: Blended and homogenized cheddar cheese
* Dietary Supplement: An analog milk
* Dietary Supplement: An analog cheese


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparently healthy men 18-40 years of age Body mass index (BMI): 18.5-24.9 kg/m^2 Non-smoker Haemoglobin concentration ≥8.4 mmol/L Exclusion Criteria: Dislike for dairy products such as milk, cheese and yoghurt Weight change >3 kg 2 months prior to study Any other blood donation < 3 month prior to study and during study, than the blood donation that is included in this study Intensive physical training (>10 hours of per week) Self-reported eating disorders or irregular eating schedules (e.g. skipping breakfast) and uncommon diets (vegetarians, vegans etc.) Alcohol intake above the recommendation from the Danish Health and Medicines Authority (>21 units of alcohol per week) Night- or shift work Food intolerance and allergies related to test products e.g. lactose and gluten Dietary supplements, if not taken on a regular basis Currently use, or use within previously 3 months of prescription medication, except non-prescription primary analgetica (NSAID and paracetamol) to relieve e.g. head ache and stomach pain, and glucocorticoider for topical use e.g. in ointment and creams. Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer), asthma, back pain, thyroid disease, heart disease, diabetes, inflammation Disorders: neurological, sleep, diagnosed psychiatric disorder, and gastro intestinal and liver disorders. Surgical treatment of obesity and abdominal surgery Inability, physically or mental, to comply with the procedures required by the study protocol as evaluated by the daily study manager, principal investigator or clinical responsible Subject's general condition contraindicates continuing the study as evaluated by the daily study manager, principal investigator or clinical responsible Simultaneous participation in other clinical intervention studies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

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: All subjects<br>Cross-over study (all subjects receive all interventions) Cheddar cheese Blended and homogenized cheddar cheese An analog milk An analog cheese | Dietary Supplement: Cheddar cheese<br>* The reference product is a commercial matured cheddar cheese<br>Dietary Supplement: Blended and homogenized cheddar cheese<br>* A blended and homogenized cheddar cheese (a spread) which, compared to the reference, has a minimal protein network and has smaller fat droplet<br>Dietary Supplement: An analog milk<br>* An anolog milk (i.e. milk with a cheese-like nutritional composition) which, compared to the reference, does not contain a protein network<br>Dietary Supplement: An analog cheese<br>* This analog cheese (a gel/yoghurt) is produced from the analog milk which, compared to the reference, has a protein network, however it is a network that differs from the reference<br>|
| Other: Healthy subjects only (subgroup)<br>If any subjects (against our hypothesis) have indices of metabolic syndrome i.e. raised fasting glucose or TG concentration, secondary analyses will be conducted to assess results without these subjects. All subjects receive all interventions) Cheddar cheese Blended and homogenized cheddar cheese An analog milk An analog cheese | Dietary Supplement: Cheddar cheese<br>* The reference product is a commercial matured cheddar cheese<br>Dietary Supplement: Blended and homogenized cheddar cheese<br>* A blended and homogenized cheddar cheese (a spread) which, compared to the reference, has a minimal protein network and has smaller fat droplet<br>Dietary Supplement: An analog milk<br>* An anolog milk (i.e. milk with a cheese-like nutritional composition) which, compared to the reference, does not contain a protein network<br>Dietary Supplement: An analog cheese<br>* This analog cheese (a gel/yoghurt) is produced from the analog milk which, compared to the reference, has a protein network, however it is a network that differs from the reference<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride | The sample size is calculated on this endpoint. Fasting and postprandial concentrations of triglycerides (mmol/L) are measured after intake of a test meal. | 0-8 hour | 
| Apolipoprotein B48 | Co-primary endpoint. Fasting and postprandial concentrations of apolipoprotein B48 are measured after intake of a test meal. | 0-8 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterol (total, LDL and HDL cholesterol) | Fasting and postprandial concentrations of cholesterol (mmol/L) are measured after intake of a test meal. | 0-8 hour | 
| Free Fatty Acid (FFA) | Fasting and postprandial concentrations of FFA (umol/L) are measured after intake of a test meal. | 0-8 hour | 
| Insulin | Fasting and postprandial concentrations of insulin (pmol/L) are measured after intake of a test meal. | 0-8 hour | 
| Glucose | Fasting and postprandial concentrations of glucose (mmol/L) are measured after intake of a test meal. | 0-8 hour | 
| Apolipoproteins | Fasting and postprandial concentrations of apolipoproteins (e.g. B100) are measured after intake of a test meal. | 0-8 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glycaemia, insulinemia, lipaemia, appetite