A Randomized, double-blind, placebo-controlled comparative clinical trial to evaluate the efficacy and safety of Probiotic Butter Spread (Probiotic Food) in Healthy Adult Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.Efficacy and safety on gut flora (% abundance of various bacterial phyla, families, genera and species with L. rhamnosus and L. reuteri separately)
研究概览
简要总结
The rationale of the study is the efficacy andsafety evaluation of Probiotic butter spread (Probiotic Food) in comparison to Standard Normal Butter. This evaluation will be carried out in subjects with borderlinehigh bloodlipid levels, to observe Probiotic response on serum lipid profile, gut health,immune marker, and serum inflammatory markerin healthy subjects with high borderline blood lipid levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age: 18 to 60 years (both inclusive) at the time of consent.
- •2.Sex: Males and Non-pregnant/Non-lactating Females (preferably equal numbers of males and females).
- •3.Females of Childbearing potential must have a negative urine pregnancy test performed on screening visit and agree to follow an accepted method of birth control for the duration of the study.
- •4.Stable weight (+/- 3 kg) for the last 3 months.
- •5.Subjects with BMI >18.4 and <25.0 kg/m² Normal to Overweight, as per Asian BMI guidelines will be included in the study.
- •6.Subjects with ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed.
- •7.Subjects willing to follow all study instructions and report to facility for all scheduled study visits.
- •8.Subjects with borderline high LDL cholesterol levels i.e. ≥ 130mg/dl and ≤ 160 mg/dl.
- •9.Subjects using a refrigerator for food storage and willing to store the product in a temperature controlled environment.
- •10.Subjects willing to provide blood, urine and stool samples as per study requirements.
- •11.Subjects willing to stay facility one day prior to study visit date to maintain overnight fasting state for every study visit.
排除标准
- •1.Subjects who admit to using any of the following drugs within the last 6 months: a.Antibiotics, anti-microbial agent, steroids, anti-Inflammatory or drugs for IBD b.Lipid lowering drugs c.Drug that suppresses gastric acid or alters gastrointestinal motility d.Cytokines e.Immunosuppressive cytotoxic agents f.Habitual consumers of antacids and laxatives g.Commercial Probiotic consumed in form of capsules etc.
- •on regular basis 2.Subjects having history of a gastrointestinal, vesicular or pancreatic disease.
- •3.Subjects with history of surgery of the gastrointestinal tract in the last 12 months.
- •4.Subject who are known Diabetic.
- •5.Subjects who admit to drinking more than 3 glasses of alcohol a day.
- •6.Subject who are having any condition of immunosuppression including HIV.
- •7.Subjects with known Cardiovascular Complications, including high Blood pressure.
- •8.Subjects with impaired renal function identified by serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female.
- •9.Subjects with history of any inter-current illness in the last 8 weeks.
- •10.Clinical evidence of active liver disease or serum alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN).
- •11.Female subjects who are Pregnant or lactating women.
- •13.Subjects who have participated in another study with any investigational product within 3 months of randomization.
结局指标
主要结局
1.Efficacy and safety on gut flora (% abundance of various bacterial phyla, families, genera and species with L. rhamnosus and L. reuteri separately)
时间窗: 1.After 43 days of treatment from baseline and between both arms. | 2.Day 1 to 43 Days of treatment and between both arms. | 3.Day 1 to 43 Days of treatment and between both arms. | 4.Day 1 to 43 Days of treatment and between both arms. | 5.On Screening Visit and Day 43
2.Effect and safety on serum inflammatory markers [hs-CRP]
时间窗: 1.After 43 days of treatment from baseline and between both arms. | 2.Day 1 to 43 Days of treatment and between both arms. | 3.Day 1 to 43 Days of treatment and between both arms. | 4.Day 1 to 43 Days of treatment and between both arms. | 5.On Screening Visit and Day 43
4.Efficacy and safety on Blood lipid profile characteristics
时间窗: 1.After 43 days of treatment from baseline and between both arms. | 2.Day 1 to 43 Days of treatment and between both arms. | 3.Day 1 to 43 Days of treatment and between both arms. | 4.Day 1 to 43 Days of treatment and between both arms. | 5.On Screening Visit and Day 43
3.To assess the effect on mean % change in immunity markers by measuring NK cell activity.
时间窗: 1.After 43 days of treatment from baseline and between both arms. | 2.Day 1 to 43 Days of treatment and between both arms. | 3.Day 1 to 43 Days of treatment and between both arms. | 4.Day 1 to 43 Days of treatment and between both arms. | 5.On Screening Visit and Day 43
5.Effect of Test products on blood parameters, change in Hematology, Liver Function Tests, Renal Function Tests.
时间窗: 1.After 43 days of treatment from baseline and between both arms. | 2.Day 1 to 43 Days of treatment and between both arms. | 3.Day 1 to 43 Days of treatment and between both arms. | 4.Day 1 to 43 Days of treatment and between both arms. | 5.On Screening Visit and Day 43
次要结局
- 1.Subjects tolerance to the test products [i.e. Flatulence, bloating, burp, rumbling, cramps, nausea, stool frequency, and stool consistency]. This will be measured on a 5-point Likert Scale by subject self-assessment questionnaire(2.Efficacy of test product on quality of life (QoL))