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

NCT ID: NCT06263686

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2016-12-31

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.

Conditions

Immune System; Innate Inflammatory Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Pasteurised yoghurt

Group Type: EXPERIMENTAL

Pasteurised yoghurt

Intervention Type: OTHER

Pasteurised (heat treated) natural yoghurt containing \<15 CFU/g of Lactobacillus delbrueckii bulgacirus and \<15 CFU/g of Streptococcus thermophilus.

Fresh natural yoghurt

Group Type: EXPERIMENTAL

Fresh yoghurt

Intervention Type: OTHER

containing ≥ 108 CFU/g of Lactobacillus delbrueckii bulgacirus and ≥ 108 CFU/g of Streptococcus thermophilus

Sterilised yoghurt

Group Type: EXPERIMENTAL

Sterilised yoghurt

Intervention Type: OTHER

Not containing viable bacteria

Interventions

Pasteurised yoghurt

Pasteurised (heat treated) natural yoghurt containing \<15 CFU/g of Lactobacillus delbrueckii bulgacirus and \<15 CFU/g of Streptococcus thermophilus.

Intervention Type: OTHER

Fresh yoghurt

containing ≥ 108 CFU/g of Lactobacillus delbrueckii bulgacirus and ≥ 108 CFU/g of Streptococcus thermophilus

Intervention Type: OTHER

Sterilised yoghurt

Not containing viable bacteria

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danone Institute International

OTHER

Sponsor Role: collaborator

University of Seville

OTHER

Sponsor Role: collaborator

University of Valladolid

OTHER

Sponsor Role: lead

Responsible Party

Alfredo Corell

Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 38931322 (View on PubMed)

Other Identifiers

DAN056

Identifier Type: -

Identifier Source: org_study_id