Immune SystemYASI-03NCT06263686
Evaluation of the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults
A study testing Pasteurised yoghurt, Fresh yoghurt and Sterilised yoghurt in people with Immune System and Innate Inflammatory Response, run by University of Valladolid.
Trial summary
In this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System, Innate Inflammatory Response
- What is being tested?
- Pasteurised yoghurt, Fresh yoghurt and Sterilised yoghurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 31 Dec 2016
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 20 and 70 years, both included.
- Healthy or mildly ill subjects (without any current chronic pharmacotherapy).
- Body mass index between 18.5 and 29.9 kg/m2, both included.
- Subjects who usually follow a balanced diet that are not engaged in any therapeutic lifestyle change involving stringent dietary interventions such as weight-reducing diets.
- Written informed consent to participate
Who cannot join
- Patients could not meet any the following criteria at the screening visit to be included in the study.
- Subjects with diseases or disorders affecting the function of the immune system, such as auto-immune diseases, allergies, atopic conditions, hypersensitivity to any kind of stimulus, or immunosupression for any reason; even if they are not currently taken any pharmacotherapy.
- Subjects with relevant functional or structural disorder affecting the gastrointestinal tract, such as malformations, angiodysplasias, active peptic ulcers or chronic inflammatory disease of the intestine; even if they are not in any specific pharmacotherapy at the time of recruitment; or who have underwent surgical procedures with permanent sequels (for example, gastroenterostomy).
- Subjects with any infectious disease requiring antibiotherapy at the time of recruitment.
- Subjects following any treatment modifying the immune response, such as immunosuppressants, corticosteroids, etc.
- Subjects with celiac disease.
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- Subjects with chronic background weakening conditions, such as diabetes or neoplasms.
- Subjects with history of renal lithiasis.
- Subjects with deficient nutritional or hydrational status.
- Subjects with relevant deviations in routine haematology or biochemistry parameters.
- Subjects with current and documented alcohol abuse.
- Subjects in whom the investigator expected insufficient collaboration or difficulties to follow the study procedures.
- Subjects who regularly took any of the forbidden products specified in the appropriate section.
About this study
Official title: Prospective, Randomized, Double-blind Parallel Group Nutritional Study to Evaluate the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults
In this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a day) of the products in healthy adults. A complete battery of in vitro tests on the activity of immune system, processes and phenomena was performed.
- Conditions
- Immune System, Innate Inflammatory Response
- Being tested
- Pasteurised yoghurt, Fresh yoghurt, Sterilised yoghurt
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasteurised yoghurtOther
Pasteurised (heat treated) natural yoghurt containing <15 CFU/g of Lactobacillus delbrueckii bulgacirus and <15 CFU/g of Streptococcus thermophilus.
Fresh yoghurtOther
containing ≥ 108 CFU/g of Lactobacillus delbrueckii bulgacirus and ≥ 108 CFU/g of Streptococcus thermophilus
Sterilised yoghurtOther
Not containing viable bacteria
| Study group | Role | What they receive |
|---|---|---|
| Pasteurised yoghurt | Experimental | Not described Receives: Other: Pasteurised yoghurt |
| Fresh natural yoghurt | Experimental | Not described Receives: Other: Fresh yoghurt |
| Sterilised yoghurt | Experimental | Not described Receives: Other: Sterilised yoghurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-cells
T-cells measured as percentage of CD3 positive cells among the blood lymphocytes (defined by gating as CD45 bright and low cellular complexity or side scatter)
Measured: Up to 6 weeks
IFN-gamma induction
T-lymphocyte function: stimulation with PHA and measurement of Intracellular synthesis of IFN-γ in terms of percentage of IFN producing cells among the CD3 CD4 double positive (T helper cells)
Measured: Up to 6 weeks
IgG
serum IgG concentration measured in mg/dl
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Jun 2016
- Primary completion1 Nov 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune SystemStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Institute International, University of Seville
- Responsible party
- Principal investigator, Alfredo Corell, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263686
- Sponsor's protocol ID
- DAN056
- Acronym
- YASI-03
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rivero-Pino F, Casquete M, Castro MJ, Redondo Del Rio P, Gutierrez E, Mayo-Iscar A, Nocito M, Corell A. Prospective, Randomized, Double-Blind Parallel Group Nutritional Study to Evaluate the Effects of Routine Intake of Fresh vs. Pasteurized Yogurt on the Immune System in Healthy Adults. Nutrients. 2024 Jun 20;16(12):1969. doi: 10.3390/nu16121969.
PubMed 38931322
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind Parallel Group Nutritional Study to Evaluate the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults
- ClinicalTrials.gov ID
- NCT06263686
- Acronym / sponsor ID
- YASI-03 / DAN056
- Conditions
- Immune System, Innate Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- Danone Institute International, University of Seville
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 16 Feb 2024 (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.
In this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a day) of the products in healthy adults. A complete battery of in vitro tests on the activity of immune system, processes and phenomena was performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pasteurised yoghurt | Experimental | Other: Pasteurised yoghurt |
| Fresh natural yoghurt | Experimental | Other: Fresh yoghurt |
| Sterilised yoghurt | Experimental | Other: Sterilised yoghurt |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 20 and 70 years, both included.
- Healthy or mildly ill subjects (without any current chronic pharmacotherapy).
- Body mass index between 18.5 and 29.9 kg/m2, both included.
- Subjects who usually follow a balanced diet that are not engaged in any therapeutic lifestyle change involving stringent dietary interventions such as weight-reducing diets.
- Written informed consent to participate
Key exclusion criteria (13 listed)
- Patients could not meet any the following criteria at the screening visit to be included in the study.
- Subjects with diseases or disorders affecting the function of the immune system, such as auto-immune diseases, allergies, atopic conditions, hypersensitivity to any kind of stimulus, or immunosupression for any reason; even if they are not currently taken any pharmacotherapy.
- Subjects with relevant functional or structural disorder affecting the gastrointestinal tract, such as malformations, angiodysplasias, active peptic ulcers or chronic inflammatory disease of the intestine; even if they are not in any specific pharmacotherapy at the time of recruitment; or who have underwent surgical procedures with permanent sequels (for example, gastroenterostomy).
- Subjects with any infectious disease requiring antibiotherapy at the time of recruitment.
- Subjects following any treatment modifying the immune response, such as immunosuppressants, corticosteroids, etc.
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 |
|---|---|---|
| Pasteurised yoghurtPasteurised (heat treated) natural yoghurt containing <15 CFU/g of Lactobacillus delbrueckii bulgacirus and <15 CFU/g of Streptococcus thermophilus. | Other | Pasteurised yoghurt |
| Fresh yoghurtcontaining ≥ 108 CFU/g of Lactobacillus delbrueckii bulgacirus and ≥ 108 CFU/g of Streptococcus thermophilus | Other | Fresh natural yoghurt |
| Sterilised yoghurtNot containing viable bacteria | Other | Sterilised yoghurt |
Primary outcome
T-cells
Time frame: Up to 6 weeks
T-cells measured as percentage of CD3 positive cells among the blood lymphocytes (defined by gating as CD45 bright and low cellular complexity or side scatter)
IFN-gamma induction
Time frame: Up to 6 weeks
T-lymphocyte function: stimulation with PHA and measurement of Intracellular synthesis of IFN-γ in terms of percentage of IFN producing cells among the CD3 CD4 double positive (T helper cells)
IgG
Time frame: Up to 6 weeks
serum IgG concentration measured in mg/dl
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 6 Jan 2025.
- Results publication: PubMed 38931322Rivero-Pino F, Casquete M, Castro MJ, Redondo Del Rio P, Gutierrez E, Mayo-Iscar A, Nocito M, Corell A. Prospective, Randomized, Double-Blind Parallel Group Nutritional Study to Evaluate the Effects of Routine Intake of Fresh vs. Pasteurized Yogurt on the Immune System in Healthy Adults. Nutrients. 2024 Jun 20;16(12):1969. doi: 10.3390/nu16121969.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pasteurised yoghurt, Fresh yoghurt and Sterilised yoghurt in people with Immune System and Innate Inflammatory Response, run by University of Valladolid.
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 5 inclusion and 13 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 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
T-cells (time frame: Up to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263686, which also lists 1 linked publication.
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 6 Jan 2025.