Evaluation of the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults (YASI-03)

University of Valladolid (UVA)

Status

Completed

Conditions

Innate Inflammatory Response

Immune System

Treatments

Other: Pasteurised yoghurt

Other: Fresh yoghurt

Other: Sterilised yoghurt

Study type

Interventional

Funder types

Other

Identifiers

NCT06263686

DAN056

Details and patient eligibility

About

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.

Enrollment

125 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.