Can Intermittent Fasting Induce Weight Loss and Improve Gut Health as Compared to Standard Medical Care in Patients With Obesity/High BMI and Crohn's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- C Reactive Protien: Change is being assessed
研究概览
简要总结
Diet is a determinant of gut microbial diversity and composition and is recognized as a potential environmental trigger for IBD; for example, high-fat diets are associated with increased risk of CD in pre-clinical models, with effects mediated through dysbiosis and altered gut permeability.
Diet is also a potential non-pharmacological therapy for weight loss and for reducing the occurrence of disease flares and the reliance on dose escalation of biologic agents. Indeed, there is accumulating evidence for the role of diet in the treatment of CD, and diet-induced improvement of microbial dysbiosis is associated with induction of remission in pediatric patients with active CD.
Intermittent Fasting (IF) is a dietary intervention that involves periodic intervals of no or very limited energy intake. We want to determine the efficacy and feasibility of a 12-week IF(Intermittent Fasting) intervention to induce weight loss (by 1 BMI unit reduction), decrease biomarker inflammation and increase microbial functional diversity compared to standard medical management (SM) in a pilot study of individuals with overweight or obesity and CD in clinical remission with elevated biomarkers of inflammation, indicated by fecal calprotectin (FCP) > 250 µg/g or C-reactive protein (CRP) > 5 mg/L).
详细描述
Objectives: To determine if a 12-week IF intervention compared to SM:
- Induces weight loss of at least 1 BMI unit.
- Reduces intestinal and systemic inflammation.
- Alters gut microbial community structure (beta-diversity) from baseline.
- Alters the adipokines and myokines leptin, adiponectin, IL-6, or irisin.
- Alters zonulin and serum levels of gastrointestinal hormones ghrehlin, glucagon-like peptide 1 (GLP-1), and glucagon-like peptide 2 (GLP-2).
- Alters body composition and whether changes in body composition have an effect on biomarkers of inflammation.
- Is a feasible and sustainable intervention for patients with CD.
Hypotheses: We hypothesize that, compared to SM, IF will:
- Induce at least a 1-unit decrease in BMI over the course of the intervention.
- Improve inflammatory markers of CD, demonstrated by a decrease in FCP by ≥ 50%, normalization of FCP to ≤ 100 µg/g, or a decrease in CRP to ≤ 5 mg/L.
- Alter gut microbial community structure (beta-diversity ) and lead to enrichment of bacterial species typically depleted in CD, such as Faecalibacterium prausnitzii and Roseburia hominus with concomitant decreases in Escherichia coli and overall Proteobacteria phylum abundance.
- Alter adipokines and myokines (leptin, adiponectin, IL-6, and irisin), zonulin and serum levels of gastrointestinal hormones (ghrehlin, GLP-1, and GLP-2).
- Alter body composition by decreasing VAT.
- Be a feasible and sustainable treatment option for patients with CD
Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 to ≤ 75 years of age;
- •ileocolonic or colonic CD in clinical remission diagnosed through conventional definitions with a Harvey Bradshaw Index (HBI) < 5 within 3 months of recruitment;
- •presence of inflammation using an FCP ≥ 250 µg/g or a CRP ≥ 5 mg/L;
- •stable dosing of biologic agents and/or immunomodulators and/or oral or rectal 5-ASA, and no changes to medical management (including corticosteroid exposure) for at least 3 months prior to recruitment
- •presence of overweight or obesity with BMI > 25 and a PG-SGA of class A.
排除标准
- •upper gastrointestinal involvement CD, fistulizing disease;
- •documented strictures based on sonographic findings or colonoscopy within the last year;
- •> 1 small bowel resection;
- •presence of an ostomy;
- •antibiotic use in past 3-months;
- •corticosteroids in the last 3 months.
结局指标
主要结局
C Reactive Protien: Change is being assessed
时间窗: Baseline and Week 12
A protein the liver produces in the presence of inflammatory disease
Fecal Calprotectin: Change is being assessed
时间窗: Baseline and Week 12
FCP is a test used to detect inflammation in the colon and is associated with disease
BMI-A decrease in BMI of at least 1 BMI unit over the course of the intervention: Change is being assessed
时间窗: Baseline and Week 12
A measure of body fat based on height and weight
次要结局
- Serum and fecal metabolomics: Change is being assessed(Baseline and Week 12)
- Body Composition: Change is being assessed(Baseline and week 12)
- Fecal microbiome: Change is being assessed(Baseline and Week 12)
- Serum markers: Change is being assessed(Baseline and week 12)
- 24 hour ASA food recalls: Change is being assessed.(Baseline and week 12)
研究者
Maitreyi Raman
Principal Investigator
University of Calgary