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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02705560
Enrollment
12
Registered
2016-03-10
Start date
2015-08-31
Completion date
2018-05-31
Last updated
2016-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

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.

Interventions

OTHERCow´s milk (3.9% fat, pasteurized)

600 ml full fat milk (organic, pasteurized, 400 kcal)

OTHERhard, yellow cheese

100 g Swiss cheese (Le Gruyère medium ripe, 400 kcal)

OTHERSoy based drink

600 ml Soy drink (540 ml soy milk (232 kcal) supplemented with 60 ml soy and plant based cream (167 kcal)

Sponsors

Agroscope Liebefeld-Posieux Research Station ALP
CollaboratorOTHER
Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Identification of dietary biomarkers of cheese and milk intake24 hours

Secondary

MeasureTime frame
Blood cell count and cell type determination6 hours
Glucose24 hours
Insulin24 hours
Transcriptomics analyses / gene expression6 hours
Total cholesterol24 hours
HDL cholesterol24 hours
LDL cholesterol24 hours
Triacylglycerides24 hours

Countries

Switzerland

Contacts

Primary ContactFrançois Pralong, MD
francois.pralong@chuv.ch004121 314 05 96
Backup ContactLinda Münger, PHD
linda.muenger@agroscope.admin.ch004158 463 83 77

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026