CTRI/2023/05/052961已完成不适用
A randomized double blind placebo controlled parallel group study to assess the gut health effects of Heat-killed Post-biotics EF2001 & beLP1 in overweight and obese adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 10
- 主要终点
- To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS)
研究概览
简要总结
The present study is a randomized, placebo-controlled, double-blind, parallel group study to assess the gut health effects of IP as compared to a placebo in overweight and obese individuals experiencing gut issues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female individuals with the age more than equal to 18 and less than equal to 45 years with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire Short Form (IPAQ-SF) -BMI of more than 25 less than 35 kg per meter square -Individuals with liver & renal function test values as defined below: -Individuals with ALT, AST values ≤ 2 times of the upper limit of normal (ULN).
- •Individuals with creatinine values ≤ 1.5 times of the upper limit of normal (ULN).
- •Individuals with ALP values ≥ 38 and ≤ 126 U/L -having at least two of the following five metabolic risk factors: -Waist circumference more than 102 centimeter (40 inches) for men and less than 88 centimeter (35 inches) for women; -Fasting triglycerides more than 150 mg per dL and less than 300 mg per d per L -Blood pressure more than equal to 130 mm Hg (Systolic Blood Pressure) and/or less than equal to 85 mm Hg (Diastolic Blood Pressure) -Fasting blood glucose more than equal to 100 mg per d per l -Fasting HDL cholesterol level less than equal 40 milligrams per deciliter (men) or less than equal 50 milligrams per deciliter (women) -History of mild to moderate gastrointestinal discomfort for at least last three months [Previous prescriptions would be mandatory] -Individuals experiencing moderate-intensity gastrointestinal symptoms, evaluated based on the combined scores of two GSRS domains (dyspeptic syndrome and bowel dysfunction), falling within the range of more than equal to 15 and less than equal to 29 over the past two weeks.
- •(The highest score out of two weeks’ GSRS scores will be taken into consideration for the study) -Willing to complete all study procedures including study-related questionnaires and comply with study requirements -Willing to abstain from other supplements or medication -Ready to give voluntary, written, informed consent to participate in the study.
- •No prohibited antibiotic usage within the last 30 days.
- •History of stable weight over the last 6 months (<10 Percentage change) -Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
排除标准
- •Individual who smokes and consumes tobacco regularly.
- •Presence of unstable, acutely symptomatic, or life-limiting illness.
- •Individuals diagnosed with diabetes and are on active medication FBG more than 125 mg/dl Individuals diagnosed with hypertension and are on active medication.
- •Individuals with uncontrolled hypertension with systolic blood pressure more than equal to 150 and/or diastolic blood pressure more than equal to 100 mm Hg. Individuals with neurological conditions causing functional or cognitive impairments Individuals with a history or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders that, in the judgment of the Investigator, would interfere with the subjects ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
- •Individuals under use of any psychotropic medication within four weeks of screening and throughout the study.
- •Individuals under use of antibiotics or signs of active systemic infection at the time of screening.
- •Treatment visits will be rescheduled to allow the subject to wash off the antibiotic for at least five days prior to any test visit.
- •Individual states they regularly consume supplemental enzymes and are unwilling to stop at least one week prior to screening and throughout the study.
- •Supplemental enzymes may include standalone enzyme supplements, probiotic supplements with enzymes, and any medications containing enzymes.
- •Individuals states they regularly consume probiotic supplements and are unwilling to stop at least one week prior to screening and throughout the study.
- •Supplemental probiotics may include standalone probiotic supplements, vitamins with probiotics, and any foods supplemented with probiotics Exposure to any non-registered drug product within 3 months prior to the screening visit.
- •Unable/unwillingness to complete study specific diaries (digital/paper-based).
- •Current use of the following medications: monoamine oxidase inhibitors, prescription or herbal weight loss medications/ dietary supplement.
- •Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- •Individual who reports alcohol intake as average of 3 or more servings per day.
- •Individuals with thyroid dysfunction as assessed by TSH more than equal to 0.4 or less than equal to 4.3 mIU/L.
- •Individuals state they have an allergy or intolerance to any ingredient in the study product or test meal.
- •Individual is deemed unsuitable for study based upon study physician assessment.
- •Individual is taking part in another clinical trial.
结局指标
主要结局
To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: Day 0 Day 42 & Day 84
次要结局
- To assess the impact of the IP from baseline as compared to placebo on the basis of(Day 42 & Day 84)
- To assess the impact of the IP at day 84 from baseline on(1 Short Chain Fatty Acids (SCFA).)
- To assess the impact of the IP on(1. Change in Body Composition as will be assessed by DEXA.)
研究者
研究点 (10)
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