The Effects of Organic Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation in Healthy Elderly Subjects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Objective Measures of Gut Microbiome Health
研究概览
简要总结
Normal aging can lead to loss of gut microbial biodiversity which is linked to inflammaging and immunosenescence or the loss of immunocompetence. Probiotics, such as VSL#3®, and certain herbal supplements such as Triphala are associated with restoration of gut community architecture, increased gut barrier function and decreased inflammation. The present project will examine the potential benefits of a synbiotic (which denotes a prebiotic plus probiotic, and in this study, is an herbal prebiotic plus probiotic) intervention (8 weeks of supplementation) on gut microbiome profiles assessed via stool, inflammatory blood markers, and questionnaires about gastrointestinal health and mood. In this exploratory study, the investigators will examine psychological and physical functioning at baseline and after 8 weeks of supplementation with synbiotic, Triphala alone, or placebo.
详细描述
Primary Aim: In healthy, cognitively intact elderly subjects, determine the effects of an 8-week synbiotic supplement intervention on the stool microbiome (pre- and post-intervention) as compared to Triphala alone and placebo.
Secondary Aim: In healthy elderly subjects, examine the effects of an 8-week synbiotic supplementation intervention on inflammatory blood markers compared to herb alone or placebo.
Exploratory Aim 1: In healthy elderly subjects, examine the effects of an 8-week synbiotic intervention on gastrointestinal and psychological health via questionnaires compared to herb alone or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study will employ double-blind masking and only the project manager will be aware if the participant is assigned to take the synbiotic, triphala alone, or placebo. At the end of the 8 weeks, participants will be made aware of their randomly assigned supplement.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cognitively intact;
- •Able to give informed consent in English;
- •Medical clearance by their doctor;
- •> 60 years of age.
排除标准
- •Alzheimer's Disease or other neurodegenerative disease such as Parkinson's Disease;
- •Current use or use in the past 3 months of antimicrobial or steroidal drugs;
- •Medical conditions affecting immune status (e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV);
- •Individuals diagnosed with Diabetes Mellitus
- •International travel in past 3 months.
- •Previous known side effect or negative reaction to VSL#3 or Triphala
研究组 & 干预措施
Placebo
Subjects will be provided both written and verbal instructions and given a kit containing placebo capsules. Subjects will be instructed to take 2 (inert) capsules with room temperature water in the morning and at bedtime.
干预措施: Placebo (Dietary Supplement)
Probiotic
Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.). Subjects will take 2 grams of organic Triphala powder with a few ounces of room temperature water in the morning and at bedtime.
干预措施: Probiotic (Dietary Supplement)
Synbiotic
Two grams of organic Triphala powder (Banyan Botanicals, Inc.) with 1 capsule VSL#3® (VSL Pharmaceuticals, Inc.) probiotic taken with a few ounces of room temperature water in the morning and at bedtime for 8 weeks. Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.) and VSL#3® (VSL Pharmaceuticals, Inc.) capsules.
干预措施: Synbiotic (Dietary Supplement)
结局指标
主要结局
Objective Measures of Gut Microbiome Health
时间窗: 8 weeks
16S rDNA sequencing of stool sample
次要结局
- Inflammatory Biomarkers(8 weeks)
研究者
Christine T. Peterson
Assistant Project Scientist
University of California, San Diego