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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: Cow´s milk (3.9% fat, pasteurized); Other: hard, yellow cheese; Other: Soy based drink

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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François Pralong, MD; Phone Number: 004121 314 05 96; Email: francois.pralong@chuv.ch
• Study Contact Backup: Name: Linda Münger, PHD; Phone Number: 004158 463 83 77; Email: linda.muenger@agroscope.admin.ch

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1011
      • Recruiting
      • Service of Endocrinology, Diabetes and Metabolism, University Hospital, CHUV
      • Contact: François Pralong, MD; Phone Number: 004121 314 05 96; Email: francois.pralong@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Collaborators: Agroscope Liebefeld-Posieux Research Station ALP
• Investigators: Principal Investigator: François Pralong, MD, CHUV

Publications and helpful links

General Publications

• Pimentel G, Burnand D, Munger LH, Pralong FP, Vionnet N, Portmann R, Vergeres G. Identification of Milk and Cheese Intake Biomarkers in Healthy Adults Reveals High Interindividual Variability of Lewis System-Related Oligosaccharides. J Nutr. 2020 May 1;150(5):1058-1067. doi: 10.1093/jn/nxaa029.
• Munger LH, Trimigno A, Picone G, Freiburghaus C, Pimentel G, Burton KJ, Pralong FP, Vionnet N, Capozzi F, Badertscher R, Vergeres G. Identification of Urinary Food Intake Biomarkers for Milk, Cheese, and Soy-Based Drink by Untargeted GC-MS and NMR in Healthy Humans. J Proteome Res. 2017 Sep 1;16(9):3321-3335. doi: 10.1021/acs.jproteome.7b00319. Epub 2017 Aug 10.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: March 5, 2016
• First Submitted That Met QC Criteria: March 5, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Estimate): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 5, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 347/15