Assessment of Dietary Biomarkers and Metabolic Effects After the Intake of Milk and Cheese

Study Overview
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Brief Summary
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Dietary biomarkers are compounds in biofluids that directly reflect the intake of specific foods or food groups. Their exploration and use in the field of dietary assessments could provide an objective measure of actual intake complementing classical assessment methods (e.g. food frequency questionnaire, 24h recalls). To date, only a limited number of foods have been covered by validated biomarkers. The study is part of the international project The Food Biomarker Alliance (FOODBALL). The study described here has been assigned to assess biomarkers of the intake of milk and cheese. Up to now, there is an evident lack of data on specific and validated biomarkers of milk and cheese (dairy products), which belong to the most relevant public health related foods in Europe. This study will further provide novel insights into the influence of fermentation of milk-based foods on metabolic effects and postprandial adaptations, which has not yet been studied in depth before using cheese as fermented product. Outcomes will support and expand earlier findings on correlation between the intake of fermented dairy products intake and human health.

Detailed Description
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This is an acute, randomized, controlled, cross-over study designed to identify dietary biomarkers of milk and cheese intake and to asses metabolic effects after the ingestion of a non-fermented product (milk) and a fermented product (cheese) in healthy subjects. Twelve healthy participants (six women, six men) in fasted state will consume three different foods in a randomized order on three different study days. Two days prior to each dietary intervention, the run-in period is initiated, during which participants have to follow a restricted diet. Participants will receive a standardised meal for the last dinner during run-in phase. The same meal will be served on the day of the dietary intervention for lunch and for dinner (period of controlled diet). Before and after ingestion of the test foods, blood samples and urine samples will be collected (up to 6 hours). Additionally, 24h-samples will be collected. Primary outcomes (metabolites) will be measured in blood serum and plasma collected at 6 different time points and in urine collected at 7 different time points. Transcriptomics analysis will be performed on whole blood samples collected at 4 time points while clinical chemistry parameters will be assessed in blood samples withdrawn at 6 different time points.

Official Title
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Randomized, Controlled, Cross-Over Study to Assess Dietary Biomarkers and Metabolic Effects After a Single Dose of Milk and Cheese in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Other: Cow´s milk (3.9% fat, pasteurized)
* Other: hard, yellow cheese
* Other: Soy based drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females Aged 18 - 40 years BMI > 18.5 and < 30 kg/m2 Daily consumption of milk No adverse effects after intake of 600 ml of milk Exclusion Criteria: Smokers Diagnosed health condition (chronic or infectious disease) Taking medication (oral contraceptive pill is allowed) Taking nutritional supplements (e.g. vitamins, minerals) Pregnant, lactating Antibiotics treatment 6 months prior to intervention Allergy to milk Allergy to soy Known intolerance to lactose Other food allergies or intolerances (e.g. histamine) Anemia (hemoglobin < 120 g/l) at the screening visit Iron deficiency (ferritin < 30 µg/l) at the screening visit Not willing/able to consume all test foods (milk, cheese and soy drink) Not willing/able to consume standardized meals Not willing to avoid drinking alcohol during study days Not willing to follow nutritional restrictions during study days

Ages Eligible for Study
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Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cow´s milk (3.9% fat, pasteurized)<br>Cow´s milk (3.9% fat, pasteurized) Single dose, 600 ml milk | Other: Cow´s milk (3.9% fat, pasteurized)<br>* 600 ml full fat milk (organic, pasteurized, 400 kcal)<br>|
| Experimental: Hard, yellow cheese<br>Hard, yellow cheese Single dose, 100 g cheese + 500 ml water | Other: hard, yellow cheese<br>* 100 g Swiss cheese (Le Gruyère medium ripe, 400 kcal)<br>|
| Active Comparator: Soy based drink<br>Soy based drink Single dose, 600 ml soy drink (soy drink + plant based cream) | Other: Soy based drink<br>* 600 ml Soy drink (540 ml soy milk (232 kcal) supplemented with 60 ml soy and plant based cream (167 kcal)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of dietary biomarkers of cheese and milk intake |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptomics analyses / gene expression |  | 6 hours | 
| Blood cell count and cell type determination |  | 6 hours | 
| Glucose |  | 24 hours | 
| Insulin |  | 24 hours | 
| Triacylglycerides |  | 24 hours | 
| Total cholesterol |  | 24 hours | 
| HDL cholesterol |  | 24 hours | 
| LDL cholesterol |  | 24 hours |