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

Healthy Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT02705560
• Study type: Interventional
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: François Pralong, MD
• Phone: 004121 314 05 96
• Email: francois.pralong@chuv.ch
• Status: Recruiting
• Phase: N/A
• Start date: August 2015
• Completion date: May 2018