To Evaluate the effect of Yakult® on the Immune System of Late Middle-aged Indian Adults.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The effect of Yakult probiotic drink (Yakult®) on NK cell activity in Indian adults (men and women) of age group 51-60 years.
研究概览
简要总结
Yakult is a functional food which is safe and being consumed in India for more than ten years now. It is backed by more than 100 human trials and has been consumed for more than 80 years by 39 million people every day. There have been no reported side effects of regular consumption of the product. One preliminary survey was undertaken in a rural Indian setting located in Pune district in a population aged 21-80 years to measure the levels of various immunological parameters including levels of NK cell activity. The findings revealed that the NK cell activity and other parameters such as IFN-γ+-producing cells (CD4 T cell, CD8 T cells, NK cell), B cells (IgA and/ IgG, plasma cell by staining with antibodies specific for – CD138, CD38 and anti-IgA or anti-IgG) among healthy Indian adults (men and women). Comparison of all the immunological parameters under consideration across age groups for adult men and women showed that the age group 51-60 years found to have low cytotoxicity of NK cell as well as low IFN- γ+ - producing NK cells and CD4+ T cells. Based on these findings and previous study age group 51-60 years seems to be the appropriate target group for enhancement in NK cell activity levels by consumption of Yakult. Thus, we concluded that the age group 51-60 years can be considered for the intervention trial of Yakult probiotic drink. The study is an intervention to evaluate the effect of a probiotic drink on the immunological parameters on Indian adults aged 51-60 years. Total 30 participants were enrolled in the study of which 29 completed the trial and one participant discontinued due to outmigration. All enrolled participants were given two bottles of Yakult® (65 ml each containing 6.5 billion Lactobacillus casei strain Shirota) on a daily basis for a total period of eight weeks. Total 30 ml of blood and up to 2ml of saliva was collected from each enrolled participant at four-time points (day 0, 28, 56, and 112 of the intervention) for immunological parameters testing and to assess the salivary IgA antibodies respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 51.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Resident of KEMHRC, Vadu HDSS area 2.Healthy men and women, Age between 51-60 years on the day of enrollment 3.Consented to participate.
- •4.Participants’ willingness and ability to comply with the requirements of the protocol.
排除标准
- •1.Study participants currently enrolled in other interventional trial 2.Inability to comply with the study protocol 3.Shift or late-night workers 4.Known/reported allergy or hypersensitivity to any medicines and foods (also including allergy against dairy products) 5.Known/reported severe chronic disease (e.g. cancer, malabsorption, physician ascertained malnutrition, severe chronic infection and infestation, renal, hepatic or cardiac diseases, artificial cardiac valve, COPD (chronic obstructive pulmonary disease), respiratory insufficiency) 6.History of any cancer, HIV infection, organ transplant or any other immune system disorder 7.Acute illness (moderate or severe) and/or fever (axillary temperature ≥ 38°C or 100.4°F) at the time of enrollment or during the 7 days prior to the enrollment.
- •(TE) 8.Known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression) or on immune suppressive drugs (within last six months) 9.Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune modifying drugs during the period starting six months prior to the enrollment.
- •However, inhaled or topical steroids are allowed.
- •10.Known/reported severe neurological, cognitive or psychiatric diseases 11.Presence of acute/chronic stress (assessed as per the stress questionnaires) 12.Known/reported eating disorders (e.g. anorexia, bulimia) 13.Reported alcohol consumption with frequency more than once in a week and regular consumption of drug 14.Regular medical treatment including over the counter (OTC), which may have impact on the study aims (e.g. probiotics, laxatives etc.) 15.Receipt of any oral or injectable antibiotics 5 days before enrollment.
- •(TE) 16.Study participants who are scheduled to undergo hospitalization during the study period 17.History of receipt of a blood transfusion, other blood products, or immune-globulins in month prior to enrollment.
- •18.Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled 19.Pregnant and lactating women 20.Any condition which the investigator considers sufficiently serious to interfere with the conduct of the trial or that constitutes any risk to the participants.
结局指标
主要结局
The effect of Yakult probiotic drink (Yakult®) on NK cell activity in Indian adults (men and women) of age group 51-60 years.
时间窗: 8 weeks
次要结局
- The effect of Yakult® on other immune parameters such as Interferon gamma cells and immunoglobulins on B cells among Indian adults (men and women) of age group 51-60 years(8 weeks)