Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 19-25 (lean), and BMI 30-35 (obese)
- •Age 18-45 years old
- •Willingness to take oral supplement and adhere to study requirements
排除标准
- •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
结局指标
主要结局
Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
时间窗: 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
Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6)
时间窗: Baseline, Day 8, Day 28
Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine
时间窗: Baseline, Day 8, Day 28
Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ
时间窗: 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
Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein
时间窗: Baseline, Day 8, Day 28
Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide
时间窗: Baseline, Day 8, Day 28
Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan
时间窗: Baseline, Day 8, Day 28
Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28
时间窗: Baseline, day 8 day 28
Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein
时间窗: Baseline, Day 8, Day 28
White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28
时间窗: baseline, day 8, and day 28
Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2
时间窗: Baseline, Day 8, Day 28
Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28
时间窗: baseline, day 8, and day 28
Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28
时间窗: baseline, day 8, and day 28
Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28
时间窗: Baseline, day 8, and day 28
Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28
时间窗: 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.
次要结局
未报告次要终点
研究者
Carol De La Motte
Assoiciate Staff
The Cleveland Clinic