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

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.

Study Overview

• Status: Completed
• Conditions: Nutrition
• Intervention / Treatment: Other: Acute milk intake; Other: Acute Yogurt intake

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Centre de Récherche en Nutrition Humaine d'Auvergne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: Acute milk intake; Food matrix: milk
Experimental: 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).	Other: Acute Yogurt intake; Food matrix: yogurt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Sergio Polakof
• Collaborators: Centre de Recherche en Nutrition Humaine d'Auvergne; Agroscope Liebefeld-Posieux Research Station ALP

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): August 6, 2019
• Study Completion (Actual): August 6, 2019

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: April 8, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: elderly; milk; yogurt; metabolomics; dairy products
• Other Study ID Numbers: FermentoMilk

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The identified individual participant data for all outcome measures will be made available, only after joined consent of promotor and investigator. Data use and transfer to a third party will be performed according to the agreement signed as part of the grant funded by CNIEL.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No