Metabolic Signatures of Dairy Products Ingestion in Humans: Effect of Age

Nutrition Clinical Trial

— FermentoMilk  

Official title:

Metabolic Signatures Resulting From Acute (Postprandial) Ingestion of Yoghurt or Milk in Humans: Effect of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03500003
• Other study ID #: FermentoMilk
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: August 6, 2019

Study information

• Verified date: August 2019
• Source: Institut National de la Recherche Agronomique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 6, 2019
• Est. primary completion date: August 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutrition

Intervention

Other:
• Acute milk intake
Food matrix: milk
• Acute Yogurt intake
Food matrix: yogurt

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine d'Auvergne	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
Sergio Polakof	Agroscope Liebefeld-Posieux Research Station ALP, Centre de Recherche en Nutrition Humaine d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	glucose homeostasis markers	Analysis of blood glucose and insulin levels	Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Secondary	lipid homeostasis markers	Analysis of blood cholesterol and triglycerides levels	Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Secondary	Inflammation markers	IL-6, TNF-alpha blood levels	Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)