Clinical trial NCT06263686: Evaluation of the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune System
Innate Inflammatory Response
Lead sponsor: University of Valladolid
Sponsor class: OTHER
Collaborators: name: Danone Institute International
name: University of Seville
First posted: 2024-02-16
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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 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.


Eligibility criteria: Inclusion criteria

* 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

Exclusion criteria

* 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.
* 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.

Primary outcomes:
measure: T-cells
timeFrame: Up to 6 weeks
measure: IFN-gamma induction
timeFrame: Up to 6 weeks
measure: IgG
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.