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

Immune System Clinical Trial

— YASI-03  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06263686
• Other study ID #: DAN056
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2024
• Source: University of Valladolid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 31, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune System
• Inflammation

Intervention

Other:
• Pasteurised yoghurt
Pasteurised (heat treated) natural yoghurt containing <15 CFU/g of Lactobacillus delbrueckii bulgacirus and <15 CFU/g of Streptococcus thermophilus.
• Fresh yoghurt
containing = 108 CFU/g of Lactobacillus delbrueckii bulgacirus and = 108 CFU/g of Streptococcus thermophilus
• Sterilised yoghurt
Not containing viable bacteria

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Valladolid	Danone Institute International, University of Seville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	IFN-gamma induction	T-lymphocyte function: stimulation with PHA and measurement of Intracellular synthesis of IFN-? in terms of percentage of IFN producing cells among the CD3 CD4 double positive (T helper cells)	Up to 6 weeks
Primary	IgG	serum IgG concentration measured in mg/dl	Up to 6 weeks