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
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Aug 2015
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 5, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMarch 10, 2016
March 1, 2016
10 months
March 5, 2016
March 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Identification of dietary biomarkers of cheese and milk intake
24 hours
Secondary Outcomes (8)
Transcriptomics analyses / gene expression
6 hours
Blood cell count and cell type determination
6 hours
Glucose
24 hours
Insulin
24 hours
Triacylglycerides
24 hours
- +3 more secondary outcomes
Study Arms (3)
Cow´s milk (3.9% fat, pasteurized)
EXPERIMENTALCow´s milk (3.9% fat, pasteurized) Single dose, 600 ml milk
Hard, yellow cheese
EXPERIMENTALHard, yellow cheese Single dose, 100 g cheese \+ 500 ml water
Soy based drink
ACTIVE COMPARATORSoy based drink Single dose, 600 ml soy drink (soy drink + plant based cream)
Interventions
600 ml full fat milk (organic, pasteurized, 400 kcal)
600 ml Soy drink (540 ml soy milk (232 kcal) supplemented with 60 ml soy and plant based cream (167 kcal)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service of Endocrinology, Diabetes and Metabolism, University Hospital, CHUV
Lausanne, Canton of Vaud, 1011, Switzerland
Related Publications (2)
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.
PMID: 32133503DERIVEDMunger 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.
PMID: 28753012DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François Pralong, MD
CHUV
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof, MD
Study Record Dates
First Submitted
March 5, 2016
First Posted
March 10, 2016
Study Start
August 1, 2015
Primary Completion
June 1, 2016
Study Completion
May 1, 2018
Last Updated
March 10, 2016
Record last verified: 2016-03