NCT02972463已完成1 期
A Randomized, Double-blind, Placebo-controlled, Parallel Dose Ranging Study on the Influence of IgY Max on Inflammatory Markers and the Gut Microbiome
Igy Nutrition, LLC1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- C-reactive protein
研究概览
简要总结
The purpose of this study is to determine the optimal dose of IgY as assessed by changes in the inflammatory marker, C-reactive protein and investigate the effect of IgY on the gut microbiome as assessed by 16s RNA sequencing of fecal samples.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults aged 18 - 60 (inclusive)
- •Self-reported complaints of minor gastrointestinal symptoms (i.e. occasional gas, bloating, etc.)
- •Non-smoker, or ex-smoker ≥6 months
- •Body mass index 25.0- 34.9kg/m2 (inclusive)
- •Female subjects of childbearing potential [i.e. not surgically sterilized or post-menopausal (greater than one year since last menses)] must have negative urine pregnancy test and must be using an effective birth control method
- •Willing to avoid alcohol consumption for 24 h prior to every clinic visit
- •Willing to maintain their regimens of medications and supplements known to alter GI function (including, but not limited to, iron supplements, calcium, and anti-depressants)
- •Willing to maintain a stable body weight, activity level and dietary pattern except for use of the study products, as directed
- •Willing and able to provide informed written consent
排除标准
- •Pregnancy or lactation, or subject unwilling to take appropriate contraceptives for the duration of the study
- •Use of prescription non-steroidal anti-inflammatory drugs (or daily use of over the counter non-steroidal anti-inflammatory drugs >1month), steroids, corticosteroids, or any other prescription anti-inflammatory drugs within 3 months prior to visit 1
- •Unstable use (i.e. initiation or change in dose) of antihypertensive medications or thyroid hormone replacement medications within 3 months prior to visit 1
- •Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 3 months prior to visit
- •Use of over the counter or prescription laxatives or stool softeners within 1 month prior to baseline (V2)
- •Use of antibiotics (other than topical) within 2 months prior to baseline (V2)
- •Use of prebiotic supplements (e.g. fructans and galacto-oligosaccharides (FOS, GOS), psyllium, fiber, inulin) or probiotic supplements (i.e. live microorganisms) within 4 weeks of baseline (V2) and consumption of foods fortified with prebiotics (e.g. inulin) or probiotics within 2 weeks of baseline (V2)
- •History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin)
- •Individuals with achlorhydria
- •Presence of major diseases such as diabetes, gastrointestinal disease, cardiovascular disease, pancreatic, renal, or liver disease
- •Chronic diarrhea or constipation, irritable bowel syndrome, or inflammatory bowel disease
- •Abdominal or gastrointestinal surgery within the previous 12 months or planned abdominal or gastrointestinal surgery in the next 4 months
- •Recent gastrointestinal food-borne illness (within 1 month prior to visit 1)
- •History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.)
- •History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years
- •Uncontrolled hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
- •Abnormal laboratory test results of clinical significance, including, but not limited to ALT or AST ≥1.5X the upper limit of normal at screening (visit 1)
- •Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of >2 standard alcoholic drinks per day
- •Extreme dietary habits (e.g. vegan or very low carbohydrate diets)
- •Subject has a known allergy or intolerance to the test products or placebo
- •Subject is unwilling or unable to abide by the requirements of the protocol
- •Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk
- •Subject has taken an investigational health product or has participated in a research study within 30 days prior to first study visit
研究组 & 干预措施
Placebo
Placebo Comparator
9 maltodextrin capsules, once daily for 12 weeks
干预措施: Placebo (Other)
IgY Max Low-Dose (1g IgY Max)
Experimental
2 Immunoglobulin Y capsules and 7 maltodextrin capsules, once daily for 12 weeks
干预措施: Immunoglobulin Y (Dietary Supplement)
IgY Max Mid-Dose (2g IgY Max)
Experimental
4 Immunoglobulin Y capsules and 5 maltodextrin capsules, once daily for 12 weeks
干预措施: Immunoglobulin Y (Dietary Supplement)
IgY Max High-Dose (4.5g IgY Max)
Experimental
9 Immunoglobulin Y capsules, once daily for 12 weeks
干预措施: Immunoglobulin Y (Dietary Supplement)
结局指标
主要结局
C-reactive protein
时间窗: 12 weeks
次要结局
- C-reactive protein(2 weeks and 4 weeks)
- Gastrointestinal Symptoms(2, 4, 8 and 12 weeks)
研究者
研究点 (1)
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