A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Vitality
研究概览
简要总结
This pilot study proposes to gain a better understanding of the health benefits of the popular "paleo-diet" in patients with irritable bowel syndrome (IBS) and explore underlying mechanisms of benefit.
详细描述
In the proposed study, the primary hypothesis is that, compared with a customary diet, consumption of a paleo-diet will improve psychological and gastrointestinal symptoms in patients with irritable bowel syndrome. Investigators also hypothesize consumption of the Paleolithic diet will result in decreased intestinal permeability, decreased inflammatory markers, and changes in the gut microbiome and microbiologic profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Vitality
时间窗: The change between baseline and 4 weeks (post-intervention).
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.
次要结局
- Anxiety(The change between baseline and 4 weeks (post-intervention).)
- Depression(The change between baseline and 4 weeks (post-intervention).)
- Activity level(The change between baseline and 4 weeks (post-intervention).)
- Gastrointestinal symptoms(The change between baseline and 4 weeks (post-intervention).)
- Visceral sensitivity(The change between baseline and 4 weeks (post-intervention).)
- Overall health status (Short Health Scale)(The change between baseline and 4 weeks (post-intervention).)
- Overall health status (EQ-5D)(The change between baseline and 4 weeks (post-intervention).)