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NCT Number: NCT06263686

Evaluation of 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.

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Key information

Conditions

Immune System Inflammation Innate Inflammatory Response Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pasteurised yoghurt

Other

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

Fresh yoghurt

Other

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

Sterilised yoghurt

Other

Not containing viable bacteria

Primary outcomes

  1. T-cells

    Time frame: Up to 6 weeks

    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)

  2. IFN-gamma induction

    Time frame: Up to 6 weeks

    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)

  3. IgG

    Time frame: Up to 6 weeks

    serum IgG concentration measured in mg/dl

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Collaborators

  • Danone Institute International
  • University of Seville

Registry information

Official study 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

Acronym: YASI-03

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 16, 2024
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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