Skip to main content
OpenTrials
Completed

NCT Number: NCT03500003

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

25 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche en Nutrition Humaine d'Auvergne

Clermont-Ferrand, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute milk intake

Other

Food matrix: milk

Acute Yogurt intake

Other

Food matrix: yogurt

Primary outcomes

  1. Metabolomics: discovery of novel biomarkers of acute dairy intake (milk and 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

Secondary outcomes

  1. glucose homeostasis markers

    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

  2. lipid homeostasis markers

    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

  3. Inflammation markers

    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

Sponsors and collaborators

Lead sponsor

Sergio Polakof

Other

Collaborators

  • Agroscope Liebefeld-Posieux Research Station ALP
  • Centre de Recherche en Nutrition Humaine d'Auvergne

Registry information

Official study title

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

Acronym: FermentoMilk

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2018
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.