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

NCT06263686 | Completed

• 1 other identifier: DAN056
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Pasteurised yoghurt

EXPERIMENTAL

Other: Pasteurised yoghurt

Fresh natural yoghurt

EXPERIMENTAL

Other: Fresh yoghurt

Sterilised yoghurt

EXPERIMENTAL

Other: Sterilised yoghurt

Interventions

Pasteurised yoghurt OTHER

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

Pasteurised yoghurt

Fresh yoghurt OTHER

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

Fresh natural yoghurt

Sterilised yoghurt OTHER

Not containing viable bacteria

Sterilised yoghurt

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valladolid: lead
• Danone Institute International: collaborator
• University of Seville: collaborator

Related Publications (1)

• 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.

  PMID: 38931322 RESULT

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 16, 2024
• Study Start: June 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 31, 2016
• Last Updated: January 6, 2025

Record last verified: 2025-01