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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02705560
• Other study ID #: 347/15
• Status: Recruiting
• Phase: N/A
• First received: March 5, 2016
• Last updated: March 5, 2016
• Start date: August 2015
• Est. completion date: May 2018

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: François Pralong, MD
• Phone: 004121 314 05 96
• Email: francois.pralong[@]chuv.ch
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Cow´s milk (3.9% fat, pasteurized)
600 ml full fat milk (organic, pasteurized, 400 kcal)
• hard, yellow cheese
100 g Swiss cheese (Le Gruyère medium ripe, 400 kcal)
• Soy based drink
600 ml Soy drink (540 ml soy milk (232 kcal) supplemented with 60 ml soy and plant based cream (167 kcal)

Locations

Country	Name	City	State
Switzerland	Service of Endocrinology, Diabetes and Metabolism, University Hospital, CHUV	Lausanne	VD

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	Agroscope Liebefeld-Posieux Research Station ALP

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of dietary biomarkers of cheese and milk intake		24 hours	No
Secondary	Transcriptomics analyses / gene expression		6 hours	No
Secondary	Blood cell count and cell type determination		6 hours	No
Secondary	Glucose		24 hours	No
Secondary	Insulin		24 hours	No
Secondary	Triacylglycerides		24 hours	No
Secondary	Total cholesterol		24 hours	No
Secondary	HDL cholesterol		24 hours	No
Secondary	LDL cholesterol		24 hours	No