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

Vaud University Hospital Center

Status: Unknown

Conditions: Healthy

Treatments: Other: Soy based drink; Other: Cow´s milk (3.9% fat, pasteurized); Other: hard, yellow cheese

Study type: Interventional

Funder types: Other

Identifiers

NCT02705560

347/15

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Cow´s milk (3.9% fat, pasteurized)

Experimental group

Description:

Cow´s milk (3.9% fat, pasteurized) Single dose, 600 ml milk

Treatment:

Other: Cow´s milk (3.9% fat, pasteurized)

Hard, yellow cheese

Experimental group

Description:

Hard, yellow cheese Single dose, 100 g cheese + 500 ml water

Treatment:

Other: hard, yellow cheese

Soy based drink

Active Comparator group

Description:

Soy based drink Single dose, 600 ml soy drink (soy drink + plant based cream)

Treatment:

Other: Soy based drink