HealthyNCT02705560
Assessment of Dietary Biomarkers and Metabolic Effects After the Intake of Milk and Cheese
A study testing Cow´s milk (3.9% fat, pasteurized), hard, yellow cheese and Soy based drink in people with Healthy, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cow´s milk (3.9% fat, pasteurized), hard, yellow cheese and Soy based drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Service of Endocrinology, Diabetes and Metabolism, University Hospital, CHUV
Lausanne, Canton of Vaud, 1011
François Pralong, MD, 004121 314 05 96, francois.pralong@chuv.ch
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Cow´s milk (3.9% fat, pasteurized), hard, yellow cheese, Soy based drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cow´s milk (3.9% fat, pasteurized)Other
600 ml full fat milk (organic, pasteurized, 400 kcal)
hard, yellow cheeseOther
100 g Swiss cheese (Le Gruyère medium ripe, 400 kcal)
Soy based drinkOther
600 ml Soy drink (540 ml soy milk (232 kcal) supplemented with 60 ml soy and plant based cream (167 kcal)
| Study group | Role | What they receive |
|---|---|---|
| Cow´s milk (3.9% fat, pasteurized) | Experimental | Cow´s milk (3.9% fat, pasteurized) Single dose, 600 ml milk Receives: Other: Cow´s milk (3.9% fat, pasteurized) |
| Hard, yellow cheese | Experimental | Hard, yellow cheese Single dose, 100 g cheese
+ 500 ml water Receives: Other: hard, yellow cheese |
| Soy based drink | Active comparator | Soy based drink Single dose, 600 ml soy drink (soy drink + plant based cream) Receives: Other: Soy based drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of dietary biomarkers of cheese and milk intake
Measured: 24 hours
Secondary outcomes (8)
Transcriptomics analyses / gene expression
Measured: 6 hours
Blood cell count and cell type determination
Measured: 6 hours
Glucose
Measured: 24 hours
Insulin
Measured: 24 hours
Triacylglycerides
Measured: 24 hours
Total cholesterol
Measured: 24 hours
HDL cholesterol
Measured: 24 hours
LDL cholesterol
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startAug 2015
- Primary completionJun 2016 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Agroscope Liebefeld-Posieux Research Station ALP
- Responsible party
- Principal investigator, Francois Pralong, Centre Hospitalier Universitaire Vaudois
- Investigators
- François Pralong, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705560
- Sponsor's protocol ID
- 347/15
- Status last verified
- Mar 2016
- First submitted
- 5 Mar 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32133503Munger 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.
PubMed 28753012
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02705560
- Acronym / sponsor ID
- 347/15
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Agroscope Liebefeld-Posieux Research Station ALP
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cow´s milk (3.9% fat, pasteurized) | Experimental | Other: Cow´s milk (3.9% fat, pasteurized)Cow´s milk (3.9% fat, pasteurized) Single dose, 600 ml milk |
| Hard, yellow cheese | Experimental | Other: hard, yellow cheeseHard, yellow cheese Single dose, 100 g cheese + 500 ml water |
| Soy based drink | Active comparator | Other: Soy based drinkSoy based drink Single dose, 600 ml soy drink (soy drink + plant based cream) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- Smokers
- Diagnosed health condition (chronic or infectious disease)
- Taking medication (oral contraceptive pill is allowed)
- Taking nutritional supplements (e.g. vitamins, minerals)
- Pregnant, lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cow´s milk (3.9% fat, pasteurized)600 ml full fat milk (organic, pasteurized, 400 kcal) | Other | Cow´s milk (3.9% fat, pasteurized) |
| hard, yellow cheese100 g Swiss cheese (Le Gruyère medium ripe, 400 kcal) | Other | Hard, yellow cheese |
| Soy based drink600 ml Soy drink (540 ml soy milk (232 kcal) supplemented with 60 ml soy and plant based cream (167 kcal) | Other | Soy based drink |
Primary outcome
Identification of dietary biomarkers of cheese and milk intake
Time frame: 24 hours
8 secondary outcomes
Transcriptomics analyses / gene expression
Time frame: 6 hours
Blood cell count and cell type determination
Time frame: 6 hours
Glucose
Time frame: 24 hours
Insulin
Time frame: 24 hours
Triacylglycerides
Time frame: 24 hours
Total cholesterol
Time frame: 24 hours
HDL cholesterol
Time frame: 24 hours
LDL cholesterol
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Derived from this study: PubMed 32133503Pimentel 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.
- Derived from this study: PubMed 28753012Munger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Pralong, MD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cow´s milk (3.9% fat, pasteurized), hard, yellow cheese and Soy based drink in people with Healthy, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Pralong, MD (004121 314 05 96, francois.pralong@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of dietary biomarkers of cheese and milk intake (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02705560, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.