NCT03500003

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

March 27, 2018

Last Update Submit

August 6, 2019

Conditions

Keywords

dairy productsmilkyogurtmetabolomicselderly

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

EXPERIMENTAL

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

Yogurt acute intake

EXPERIMENTAL

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

Interventions

Food matrix: milk

Milk acute intake

Food matrix: yogurt

Yogurt acute intake

Eligibility Criteria

Age25 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Locations