Effects of a Fasting Mimicking Diet on Depressive Symptoms in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Changes in Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
Inflammatory bowel disease (IBD) is a chronic illness characterized by inflammation of the intestine. Many individuals with IBD suffer from depressive symptoms and anxiety which can lead to a decreased quality of life, poor treatment compliance, and higher morbidity and mortality. The object of this clinical trial is to investigate the effects of a fasting mimicking diet in IBD patients who are suffering with symptoms of depression. Participants will carry out 3 cycles of a 5-day period of a plant-based low caloric diet or a plant-based caloric sufficient diet following by 3 weeks of eating normally. Effects of the dietary intervention on microbes in the gut, immune and metabolic function, and depressive symptoms will be measured. The overall goal is to develop a safe and effective treatment to improve mental health in patients with IBD by targeting the gut microbiome through dietary interventions.
详细描述
The primary objective of this proof of principle study is to investigate the effects of a fasting mimicking diet on depressive symptoms in patients with inflammatory bowel disease.
The specific aims of this project include:
- Determine whether a fasting-mimicking diet is effective in ameliorating depressive symptoms in patients with Crohn's disease or ulcerative colitis
- Determine if beneficial effects seen during the interventional period are sustained following cessation of fasting
- Examine effects of the intervention on the gut microbiome and metabolome
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)
盲法说明
Investigator and lab personnel involved in assessment of outcomes will be blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 65 years at the time of screening
- •Diagnosis of Crohn's disease in clinical remission with Harvey Bradshaw Index (HBI<5) or diagnosis of ulcerative colitis in clinical remission with partial Mayo (pMayo<2)
- •Suffering from mild-moderate depression with PHQ-9 ≥5 and ≤ 19
排除标准
- •Subjects who are reliant on partial or total parenteral nutrition
- •Subjects with prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine, total colectomy, proctocolectomy, or ileoanal pouch
- •Subjects with diabetes or celiac disease
- •Subjects with a body mass index (BMI) lower than 18
- •Subjects suffering from malnutrition or at high risk of malnutrition assessed by a score of ≥6 on the abridged patient generated subjective global assessment (PGSGA)
- •Subjects allergic to nuts
- •Subjects currently on a fasting/intermittent type caloric restricted diet
- •History of psychotic or bipolar disorders or experiencing suicidal thoughts
- •Pregnant women, women who are breast feeding, or women planning on becoming pregnant
- •Subjects with immune-compromised condition other than inflammatory bowel disease (e.g. AIDS, lymphoma)
- •Subjects with severe uncontrolled cardiovascular or respiratory disease or active malignancy
- •Unable to read English or provide informed consent
结局指标
主要结局
Changes in Patient Health Questionnaire (PHQ-9)
时间窗: From baseline through 12 and 24 weeks
A change in depressive symptoms as assessed through the Patient Health Questionnaire (PHQ)-9. \[Min:0; Max 27; good to poor\]
次要结局
- Changes in blood cytokines(From baseline through 12 and 24 weeks)
- Changes in body mass index (BMI)(From baseline through 12 and 24 weeks)
- Changes in partial Mayo Score in patients with ulcerative colitis(From baseline through 12 and 24 weeks)
- Changes in gene expression in peripheral blood mononuclear cells(From baseline through 12 and 24 weeks)
- Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease(From baseline through 12 and 24 weeks)
- Changes in general anxiety(From baseline through 12 and 24 weeks)
- Changes in levels of fatigue(From baseline through 12 and 24 weeks)
- Changes in weight(From baseline through 12 and 24 weeks)
- Changes in fecal bile acids(From baseline through 12 and 24 weeks)
- Changes in quality of Life(From baseline through 12 and 24 weeks)
- Changes in fecal short chain fatty acids(From baseline through 12 and 24 weeks)
- Changes in blood hormones(From baseline through 12 and 24 weeks)
- Changes in gut microbiome(From baseline through 12 and 24 weeks)
- Changes in clinical markers of disease(From baseline through 12 and 24 weeks)