Centre de Recherche en Nutrition Humaine d'Auvergne
Clermont-Ferrand, 63000, France
NCT Number: NCT03500003
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.
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Notify Me25 year–80 year
Male
Interventional
Not applicable
Clermont-Ferrand, 63000, France
The two main objectives of this project are to:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Food matrix: milk
Food matrix: yogurt
Time frame: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Analysis of the urine and plasma metabolome
Time frame: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Analysis of blood glucose and insulin levels
Time frame: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Analysis of blood cholesterol and triglycerides levels
Time frame: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
IL-6, TNF-alpha blood levels
Sergio Polakof
Other
Metabolic Signatures Resulting From Acute (Postprandial) Ingestion of Yoghurt or Milk in Humans: Effect of Age
Acronym: FermentoMilk
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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