Clinical trial NCT03500003: Metabolic Signatures of Dairy Products Ingestion in Humans: Effect of Age
Official title: Metabolic Signatures Resulting From Acute (Postprandial) Ingestion of Yoghurt or Milk in Humans: Effect of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition
Keywords: dairy products
milk
yogurt
metabolomics
elderly
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Nutrition Humaine d'Auvergne
name: Agroscope Liebefeld-Posieux Research Station ALP
First posted: 2018-04-17
Enrollment: 28
Sex: MALE
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Despite the fact that dairy products are greatly consumed, it remains today very difficult to determine with a classical blood biochemical test whether a person has ingested a fresh fermented dairy product or just milk, while their biological, metabolic and health impacts may be different.

The metabolic footprint left by the consumption of these products could be modified by the age of the consumer. Indeed, in the elderly, the processes of digestion, assimilation and metabolism are known to be altered /different compared to healthy adults. Thus, different metabolic signatures in the elderly could appear as the result of a less effective use and metabolism of the nutrients ingested. This could further also result in different or altered biological effects on dairy products.

Detailed description: The two main objectives of this project are to:

* Determine precisely the plasma and urine metabolic signatures resulting from acute (postprandial) ingestion of yogurt or milk.
* Characterize the metabolic signature following the consumption of these dairy products in the elderly and compared with the signature of reference (adult).
* Understand the mechanisms and metabolic pathways involved if discriminating metabolites between age are detected..

The clinical study is open, monocentric, controlled and randomized, in a cross experimental design.

The study is not performed in a double blind way. However, the measure bias will be limited because of the standardized and objective characteristic of the main criteria. Moreover, biological samples will be analyzed by the same partners of the project. Each subject will be its own control, so that confusion factors related to individual variability will be eliminated.

A total of 28 volunteers (men) will participate in the study: 14 adults and 14 old people (\>65 yrs-old). After 3 weeks of controlled diet (without consumption of dairy products) the volunteers will ingest 600g of milk or yogurt. After 1 week of wash-out, the other product will be consumed. Blood and urine will be collected during the postprandial period.

The monocentric characteristic of the study, the low number of subjects and the expertise of the involved staff will enable to limit the number of missing data.

The randomization (latin square) has been established by a bio-statistician of the project before the study started. A document describing the randomization proceeding is confidentially kept.

Eligibility criteria: Inclusion Criteria:

* no pathology and no medical treatment
* BMI \>=21 and \<=30 kg/m²
* normal biological status
* no dislike for diary intake

Exclusion Criteria:

* smoking
* no pathology and no medical treatment (no antibiotics in the last 3 months)
* consumption of nutritional supplements several times at week

Primary outcomes:
measure: Metabolomics: discovery of novel biomarkers of acute dairy intake (milk and yogurt)
timeFrame: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Secondary outcomes:
measure: glucose homeostasis markers
timeFrame: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
measure: lipid homeostasis markers
timeFrame: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
measure: Inflammation markers
timeFrame: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre de Recherche en Nutrition Humaine d'Auvergne
Study officials:
References: