Metabolic Signatures of Dairy Products Ingestion in Humans: Effect of Age
FermentoMilk
Metabolic Signatures Resulting From Acute (Postprandial) Ingestion of Yoghurt or Milk in Humans: Effect of Age
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2019
CompletedAugust 7, 2019
August 1, 2019
1.2 years
March 27, 2018
August 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolomics: discovery of novel biomarkers of acute dairy intake (milk and yogurt)
Analysis of the urine and plasma metabolome
Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Secondary Outcomes (3)
glucose homeostasis markers
Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
lipid homeostasis markers
Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Inflammation markers
Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Study Arms (2)
Milk acute intake
EXPERIMENTAL14 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).
Yogurt acute intake
EXPERIMENTAL14 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).
Interventions
Eligibility Criteria
You may qualify if:
- no pathology and no medical treatment
- BMI \>=21 and \<=30 kg/m²
- normal biological status
- no dislike for diary intake
You may not qualify if:
- smoking
- no pathology and no medical treatment (no antibiotics in the last 3 months)
- consumption of nutritional supplements several times at week
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de Recherche en Nutrition Humaine d'Auvergne
Clermont-Ferrand, 63000, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
March 27, 2018
First Posted
April 17, 2018
Study Start
June 1, 2018
Primary Completion
August 6, 2019
Study Completion
August 6, 2019
Last Updated
August 7, 2019
Record last verified: 2019-08