Metabolic Signatures of Dairy Products Ingestion in Humans: Effect of Age
NCT ID: NCT03500003
Last Updated: 2019-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2018-06-01
2019-08-06
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Milk acute intake
14 adult and 14 elderly volunteers will consume 600mL of milk. Blood (11 sampling points) and urine samples (3 collection points) will be collected before the ingestion and during the postprandial period (6h).
Acute milk intake
Food matrix: milk
Yogurt acute intake
14 adult and 14 elderly volunteers will consume 600mL of yogurt. Blood (11 sampling points) and urine samples (3 collection points) will be collected before the ingestion and during the postprandial period (6h).
Acute Yogurt intake
Food matrix: yogurt
Interventions
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Acute milk intake
Food matrix: milk
Acute Yogurt intake
Food matrix: yogurt
Eligibility Criteria
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Inclusion Criteria
* BMI \>=21 and \<=30 kg/m²
* normal biological status
* no dislike for diary intake
Exclusion Criteria
* no pathology and no medical treatment (no antibiotics in the last 3 months)
* consumption of nutritional supplements several times at week
25 Years
80 Years
MALE
Yes
Sponsors
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Centre de Recherche en Nutrition Humaine d'Auvergne
OTHER_GOV
Agroscope Liebefeld-Posieux Research Station ALP
OTHER
Sergio Polakof
OTHER
Responsible Party
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Sergio Polakof
PhD
Locations
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Centre de Recherche en Nutrition Humaine d'Auvergne
Clermont-Ferrand, , France
Countries
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Other Identifiers
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FermentoMilk
Identifier Type: -
Identifier Source: org_study_id
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