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

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.

Study Overview

• Status: Completed
• Conditions: Immune System; Innate Inflammatory Response
• Intervention / Treatment: Other: Pasteurised yoghurt; Other: Fresh yoghurt; Other: Sterilised yoghurt

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pasteurised yoghurt	Other: Pasteurised yoghurt; Pasteurised (heat treated) natural yoghurt containing <15 CFU/g of Lactobacillus delbrueckii bulgacirus and <15 CFU/g of Streptococcus thermophilus.
Experimental: Fresh natural yoghurt	Other: Fresh yoghurt; containing ≥ 108 CFU/g of Lactobacillus delbrueckii bulgacirus and ≥ 108 CFU/g of Streptococcus thermophilus
Experimental: Sterilised yoghurt	Other: Sterilised yoghurt; Not containing viable bacteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Up to 6 weeks
IgG	serum IgG concentration measured in mg/dl	Up to 6 weeks

Collaborators and Investigators

• Sponsor: University of Valladolid
• Collaborators: Danone Institute International; University of Seville

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: DAN056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No