NutritionFermentoMilkNCT03500003
Metabolic Signatures of Dairy Products Ingestion in Humans: Effect of Age
A study testing Acute milk intake and Acute Yogurt intake in people with Nutrition, run by Sergio Polakof at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 25 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition
- What is being tested?
- Acute milk intake and Acute Yogurt intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to 6 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no pathology and no medical treatment
- BMI >=21 and <=30 kg/m²
- normal biological status
- no dislike for diary intake
Who cannot join
- smoking
- no pathology and no medical treatment (no antibiotics in the last 3 months)
- consumption of nutritional supplements several times at week
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Humaine d'Auvergne
Clermont-Ferrand, 63000
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutrition
- Being tested
- Acute milk intake, Acute Yogurt intake
- Keywords
- dairy products, milk, yogurt, metabolomics, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute milk intakeOther
Food matrix: milk
Acute Yogurt intakeOther
Food matrix: yogurt
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Acute Yogurt intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomics: discovery of novel biomarkers of acute dairy intake (milk and yogurt)
Analysis of the urine and plasma metabolome
Measured: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Secondary outcomes (3)
glucose homeostasis markers
Analysis of blood glucose and insulin levels
Measured: 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
Measured: 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
Measured: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Jun 2018
- Primary completion6 Aug 2019
- Study completion6 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sergio Polakof
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Agroscope Liebefeld-Posieux Research Station ALP
- Responsible party
- Sponsor-investigator, Sergio Polakof, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500003
- Sponsor's protocol ID
- FermentoMilk
- Acronym
- FermentoMilk
- Status last verified
- Aug 2019
- First submitted
- 27 Mar 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Signatures Resulting From Acute (Postprandial) Ingestion of Yoghurt or Milk in Humans: Effect of Age
- ClinicalTrials.gov ID
- NCT03500003
- Acronym / sponsor ID
- FermentoMilk / FermentoMilk
- Conditions
- Nutrition
- Keywords
- dairy products, milk, yogurt, metabolomics, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sergio PolakofUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Agroscope Liebefeld-Posieux Research Station ALP
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk acute intake | Experimental | Other: Acute milk intake14 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 | Experimental | Other: Acute Yogurt intake14 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). |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- no pathology and no medical treatment
- BMI >=21 and <=30 kg/m²
- normal biological status
- no dislike for diary intake
Key exclusion criteria (3 listed)
- smoking
- no pathology and no medical treatment (no antibiotics in the last 3 months)
- consumption of nutritional supplements several times at week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute milk intakeFood matrix: milk | Other | Milk acute intake |
| Acute Yogurt intakeFood matrix: yogurt | Other | Yogurt acute intake |
Primary outcome
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
3 secondary outcomes
glucose homeostasis markers
Time frame: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
lipid homeostasis markers
Time frame: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Inflammation markers
Time frame: Baseline, then ten times during the 6h following product intake on two different days (one milk, one yogurt)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute milk intake and Acute Yogurt intake in people with Nutrition, run by Sergio Polakof at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.