Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with mild to moderate Irritable Bowel Syndrome (IBS) and mild to moderate anxiety or depression
- Other causes of bowel symptoms excluded to the satisfaction of the Study Team
- Age at least 18 years at initial screening visit
- Patients who are able to sign and understand the study's informed consent form
- Patients able to complete all screening evaluations and procedures
Exclusion Criteria:
- Patients in inpatient hospital care
- Severe or refractory bowel or psychological symptoms
- Current consumption of a Paleolithic diet
- Known Celiac disease
- Uncontrolled thyroid disease as indicated by an abnormal thyroid stimulating hormone (TSH) level
- Uncontrolled diabetes as indicated by a HbA1c equal to 6.5 or greater
- Patients unable to speak English
- Inability to obtain informed consent
- Pregnant or nursing women
- Any condition, which in the opinion of the investigator, would interfere with study requirements
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Paleolithic Diet
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Paleolithic diet
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有源比较器:General Healthful Diet
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General Healthful Diet
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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 |
---|---|---|
Vitality
大体时间:The change between baseline and 4 weeks (post-intervention).
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Vitality as measured on the vitality subscale of the short form health survey (SF36).
This instrument assesses vitality (energy level and fatigue) and is a subscale of SF36, a general health survey designed for use in clinical practice and research, health policy evaluation and general population surveys.
The Vitality Subscale score is determined by responses to 4 items: Did you feel full of life?
Did you have a lot of energy?
Did you feel worn out?
Did you feel tired?
The lower the score the more disability.
The higher the score the less disability.
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The change between baseline and 4 weeks (post-intervention).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Anxiety
大体时间:The change between baseline and 4 weeks (post-intervention).
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Anxiety as measured by the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire. GAD-7 Questionnaire: This is a 7 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate detection of anxiety as well as for longitudinal anxiety symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms. |
The change between baseline and 4 weeks (post-intervention).
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Depression
大体时间:The change between baseline and 4 weeks (post-intervention).
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Depression as measured by the Patient Health Questionnaire-9' (PHQ-9) questionnaire. PHQ-9: This is a 9 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate diagnosis of depression as well as for longitudinal depression symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms. |
The change between baseline and 4 weeks (post-intervention).
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Activity level
大体时间:The change between baseline and 4 weeks (post-intervention).
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Activity level/amount of exercise as measured by the Godin Leisure-Time Exercise Questionnaire.
The Godin Leisure-Time Exercise Questionnaire is a simple questionnaire to measure a person's leisure time exercise.
It is designed to be reliable valid and easy to complete quickly without a need for detailed review.
Lower scores indicate less activity and higher scores equal more activity.
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The change between baseline and 4 weeks (post-intervention).
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Gastrointestinal symptoms
大体时间:The change between baseline and 4 weeks (post-intervention).
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Gastrointestinal symptoms as measured by the NIH-Promis Gastrointestinal Symptom Scale a. NIH-Promis Gastrointestinal Symptom Scales for 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). Lower scores indicate less severe symptoms and higher scores equal more severe symptoms. |
The change between baseline and 4 weeks (post-intervention).
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Visceral sensitivity
大体时间:The change between baseline and 4 weeks (post-intervention).
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Visceral sensitivity as measured by the Visceral Sensitivity Index.
Visceral Sensitivity Index assesses gastrointestinal-specific anxiety, the cognitive, affective, and behavioral response to fear of gastrointestinal sensations, symptoms, and the context in which these visceral sensations and symptoms occur.
Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
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The change between baseline and 4 weeks (post-intervention).
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Overall health status (Short Health Scale)
大体时间:The change between baseline and 4 weeks (post-intervention).
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Overall health status as measured by the Short Health Scale questionnaires.
The "Short Health Scale" is a 4-item questionnaire covering aspects of subjective health.
Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
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The change between baseline and 4 weeks (post-intervention).
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Overall health status (EQ-5D)
大体时间:The change between baseline and 4 weeks (post-intervention).
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Overall health status (global health outcomes measure) as measured by the EuroQol 5 Dimension (EQ-5D) The EQ-5D descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression.
Scores range from 5-25, with higher scores indicating more severe symptoms/decreased quality of life.descriptive
system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression.
Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
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The change between baseline and 4 weeks (post-intervention).
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Intestinal permeability
大体时间:The change between baseline and 4 weeks (post-intervention).
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Change in intestinal permeability as measured by plasma zonulin levels
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The change between baseline and 4 weeks (post-intervention).
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Change in inflammatory markers
大体时间:The change between baseline and 4 weeks (post-intervention).
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Change in inflammatory markers as measured by serum C-reactive protein levels
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The change between baseline and 4 weeks (post-intervention).
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Change in stool metabolomics
大体时间:The change between baseline and 4 weeks (post-intervention).
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Change in stool metabolomics as measured by stool metabolite testing.
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The change between baseline and 4 weeks (post-intervention).
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Change in stool microbiome profile
大体时间:The change between baseline and 4 weeks (post-intervention).
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Change in stool microbiota profile as measured by 16S DNA sequencing of stool samples.
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The change between baseline and 4 weeks (post-intervention).
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Biobank specimen collection of urine.
大体时间:The change between baseline and 4 weeks (post-intervention).
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Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
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The change between baseline and 4 weeks (post-intervention).
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Biobank specimen collection of stool.
大体时间:The change between baseline and 4 weeks (post-intervention).
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Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
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The change between baseline and 4 weeks (post-intervention).
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Biobank specimen collection of saliva.
大体时间:The change between baseline and 4 weeks (post-intervention).
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Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
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The change between baseline and 4 weeks (post-intervention).
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Biobank specimen collection of blood.
大体时间:The change between baseline and 4 weeks (post-intervention).
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Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
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The change between baseline and 4 weeks (post-intervention).
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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