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

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ClinicalTrials.gov Identifier: NCT02705560
Recruitment Status : Unknown
Verified March 2016 by Francois Pralong, Centre Hospitalier Universitaire Vaudois.
Recruitment status was:  Recruiting
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Collaborator:
Agroscope Liebefeld-Posieux Research Station ALP
Information provided by (Responsible Party):
Francois Pralong, Centre Hospitalier Universitaire Vaudois

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.


Condition or disease Intervention/treatment Phase
Healthy Other: Cow´s milk (3.9% fat, pasteurized) Other: hard, yellow cheese Other: Soy based drink Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : August 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : May 2018

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)




Primary Outcome Measures :
  1. Identification of dietary biomarkers of cheese and milk intake [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Transcriptomics analyses / gene expression [ Time Frame: 6 hours ]
  2. Blood cell count and cell type determination [ Time Frame: 6 hours ]
  3. Glucose [ Time Frame: 24 hours ]
  4. Insulin [ Time Frame: 24 hours ]
  5. Triacylglycerides [ Time Frame: 24 hours ]
  6. Total cholesterol [ Time Frame: 24 hours ]
  7. HDL cholesterol [ Time Frame: 24 hours ]
  8. LDL cholesterol [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705560


Contacts
Contact: François Pralong, MD 004121 314 05 96 francois.pralong@chuv.ch
Contact: Linda Münger, PHD 004158 463 83 77 linda.muenger@agroscope.admin.ch

Locations
Switzerland
Service of Endocrinology, Diabetes and Metabolism, University Hospital, CHUV Recruiting
Lausanne, VD, Switzerland, 1011
Contact: François Pralong, MD    004121 314 05 96    francois.pralong@chuv.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Agroscope Liebefeld-Posieux Research Station ALP
Investigators
Principal Investigator: François Pralong, MD CHUV

Responsible Party: Francois Pralong, Prof, MD, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02705560     History of Changes
Other Study ID Numbers: 347/15
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016