Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health
2020年8月19日 更新者：Carol De La Motte、The Cleveland Clinic
The purpose of this study is to evaluate whether oral HA35 supplementation changes the normal intestinal bacteria, increases intestinal protection, decrease intestinal inflammation and permeability, and to assess any health benefits and confirm the safety profile of HA35.
研究概览
研究类型
介入性
注册 (实际的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Foundation
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- BMI 19-25 (lean), and BMI 30-35 (obese)
- Age 18-45 years old
- Willingness to take oral supplement and adhere to study requirements
Exclusion Criteria:
- Diabetes
- Oral antibiotics within 4 weeks of study initiation
- History of cardiac disease, and medications for cardiac disease
- Use statins and antihypertensive drugs
- Inflammatory bowel disease including irritable bowel syndrome
- History of intestinal surgery, excluding hernia repair and appendectomy
- Active cancer diagnosis (except skin cancer)
- Chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)
- Immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)
- Vegetarian or vegan diet7
- Abnormal liver or kidney function as measured by routine serum chemistry testing
- Severe anemia or significant white blood cell or platelet abnormalities
- No additional blood or blood product donations during the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Healthy Controls ages 18-45 with BMI of 19-25 or 30-35
Single Arm study
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
大体时间：Baseline, Day 8, Day 28
|
Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria.
As an example a relative abundance of firmicutes equal to 0.9 would mean that 90% of the bacteria identified in a sample are firmicutes
|
Baseline, Day 8, Day 28
|
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Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine
大体时间：Baseline, Day 8, Day 28
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Baseline, Day 8, Day 28
|
|
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Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide
大体时间：Baseline, Day 8, Day 28
|
Baseline, Day 8, Day 28
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Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ
大体时间：Baseline, Day 8, Day 28
|
The respiratory quotient is a ratio between the volume of carbon dioxide exhaled and the volume of oxygen inhaled during respiration.
It typically ranges between 0.7 and 1.0 and is an indicator of metabolic fuel or substrate use in tissues; it must be calculated under resting or steady-state exercise conditions.
A ratio of 0.7 is indicative of mixed fat use, whereas a ratio of 1.0 indicates the exclusive use of carbohydrates
|
Baseline, Day 8, Day 28
|
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Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein
大体时间：Baseline, Day 8, Day 28
|
Baseline, Day 8, Day 28
|
|
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Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2
大体时间：Baseline, Day 8, Day 28
|
Baseline, Day 8, Day 28
|
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Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan
大体时间：Baseline, Day 8, Day 28
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Baseline, Day 8, Day 28
|
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Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6)
大体时间：Baseline, Day 8, Day 28
|
Baseline, Day 8, Day 28
|
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Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein
大体时间：Baseline, Day 8, Day 28
|
Baseline, Day 8, Day 28
|
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Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28
大体时间：Baseline, day 8 day 28
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Baseline, day 8 day 28
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White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28
大体时间：baseline, day 8, and day 28
|
baseline, day 8, and day 28
|
|
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Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28
大体时间：baseline, day 8, and day 28
|
baseline, day 8, and day 28
|
|
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Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28
大体时间：baseline, day 8, and day 28
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baseline, day 8, and day 28
|
|
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Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28
大体时间：Baseline, day 8, and day 28
|
Baseline, day 8, and day 28
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Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28
大体时间：Baseline, day 8, and day 28
|
This values measures the amount of energy a person uses during rest and compares it the average expected number of someone who is the same gender, age, and race.
|
Baseline, day 8, and day 28
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Hill DR, Kessler SP, Rho HK, Cowman MK, de la Motte CA. Specific-sized hyaluronan fragments promote expression of human beta-defensin 2 in intestinal epithelium. J Biol Chem. 2012 Aug 31;287(36):30610-24. doi: 10.1074/jbc.M112.356238. Epub 2012 Jul 3.
- Hill DR, Rho HK, Kessler SP, Amin R, Homer CR, McDonald C, Cowman MK, de la Motte CA. Human milk hyaluronan enhances innate defense of the intestinal epithelium. J Biol Chem. 2013 Oct 4;288(40):29090-104. doi: 10.1074/jbc.M113.468629. Epub 2013 Aug 15.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年7月1日
初级完成 (实际的)
2017年9月20日
研究完成 (实际的)
2019年6月20日
研究注册日期
首次提交
2016年8月9日
首先提交符合 QC 标准的
2016年8月11日
首次发布 (估计)
2016年8月16日
研究记录更新
最后更新发布 (实际的)
2020年9月3日
上次提交的符合 QC 标准的更新
2020年8月19日
最后验证
2020年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.