A Randomized, Double-Blind, Placebo-Controlled, Comparative Study to Determine Effects of Synbiotic Test Product on Immune Markers and Gut Health In Elderly Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 2. To assess the effect of test product and control products on mean % change in immunity markers i.e. Cytokines level (IFN-g, IL-1 Beta, IL-10, IL-17 and TNF-alpha).
研究概览
简要总结
Comparative Study toDetermine Effects of Prebiotic, Probiotics, Symbiotic and Placebo Test Productson Immune Markers and Gut Health In Elderly Population. Test products will betested against controls involving 120 subjects. Total study duration is 90days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 50.00 Year(s) 至 65.00 Year(s)（—）
入选标准
- •Age: 50 to 65 years (both inclusive) old at the time of consent.
- •Subjects with BMI: In between 18.5 to 27.5 kg/m
- •Gender: Male or females (Post menopausal female with history at least one year of amenorrhea).
- •Subjects who are sensitive to weather change, cold, cough, fever, sore throat/throat infection etc.
- •by medical history.
- •Subjects with generally good health conditions, free from any disease condition to affect their dietary intake.
- •Subjects with no known side effect/allergy or intolerance to milk, Probiotic, prebiotic or synbiotics or any similar products/food/food ingredients.
- •Subjects must be able to understand and provide written informed consent to participate in the study.
- •Subjects should be willing and able to follow the study protocol to participate in the study.
排除标准
- •Subjects with current use or use in the past 3 months of antimicrobial or steroidal drugs or any prescription medication.
- •Subjects who are not ready to refrain from taking fermented foods like dosa, idly, butter milk, curd, any other supplements (Prebiotic, probiotic, synbiotics etc.) during this study period as well at least 2 week before enrollment.
- •(Refer attached appendix IV).
- •Subjects who are taking fiber supplement or any micronutrient supplement during this study period as well at least 2 week before enrollment.
- •Subjects with medical conditions affecting immune status (e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV) or taking medicine which may have impacts on immune system like antibiotics, antimicrobial, probiotic sachets.
- •Subjects with known history of Diabetes (any form) or any other disease condition which affect their daily dietary intake.
- •History of drug and alcohol abuse.
- •Participation in a similar clinical study within the previous 90 days.
- •Any surgical treatment previous three months or planned during the study.
- •Any subject in the Principal investigators opinion not considered suitable for enrollment.
结局指标
主要结局
2. To assess the effect of test product and control products on mean % change in immunity markers i.e. Cytokines level (IFN-g, IL-1 Beta, IL-10, IL-17 and TNF-alpha).
时间窗: 1. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products’ groups. | 2. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products’ groups. | 3. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products’ groups.
1. To assess the effect of test product and control products on mean % change in immunity markers by measuring NK cell activity.
时间窗: 1. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products’ groups. | 2. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products’ groups. | 3. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products’ groups.
3.To assess the effect of test product and control products in terms of change in gut microbes by NGS in feces.
时间窗: 1. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products’ groups. | 2. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products’ groups. | 3. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products’ groups.
次要结局
- 1. To assess the effect of test product and control products on change in the occurrence of cold/ cough frequency by asking questions to subjects.(1.Baseline i.e. Day 1 before administration of products to Day 90.)