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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 主要终点
- T-cells
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Pasteurised yoghurt
干预措施: Pasteurised yoghurt (Other)
Fresh natural yoghurt
干预措施: Fresh yoghurt (Other)
Sterilised yoghurt
干预措施: Sterilised yoghurt (Other)
结局指标
主要结局
T-cells
时间窗: 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)
IFN-gamma induction
时间窗: 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)
IgG
时间窗: Up to 6 weeks
serum IgG concentration measured in mg/dl
次要结局
未报告次要终点
研究者
Alfredo Corell
Proffesor
University of Seville