NCT03852069已完成不适用
Impact of a Diet Rich in Inulin-type Fructans Combined With Inulin Supplementation on Gut Microbiota Composition and Metabolic Parameters in Obese Patients
Cliniques universitaires Saint-Luc- Université Catholique de Louvain0 个研究点目标入组 106 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 主要终点
- Gut microbiota composition
研究概览
简要总结
The purpose of the study was to evaluate the effect of a diet based on ITF-rich vegetables in combination with purified ITF supplementation on weight management, metabolic alteration and gut microbiota composition. Obese patients were treated for 3 months and several parameters were measured before and after the study period.
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
- Single (Participant)
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
- •Body mass index > 30 kg/m²
- •Caucasian
- •Presence of at least one of the following comorbidity : prediabetes, diabetes, dyslipidemia, hypertension, steatosis.
排除标准
- •Psychiatric problems or use of antipsychotic
- •Consumption of antibiotics, pro/prebiotics, fibre dietary supplement, or any molecules that modifies the intestinal transit (<6 weeks)
- •Pregnancy in progress or planified within 6 months
- •Specific dietary practise (vegetarian, vegan,...)
- •Specific dietary treatment (<6 weeks) (e.g. high protein diet)
- •Type 1 diabetes
- •Excessive alcohol consumption (>3 glasses/day)
- •Inconclusive acceptability test (regarding the protocol of the intervention and the vegetables used in the protocol)
研究组 & 干预措施
Placebo
Placebo Comparator
16 g maltodextrin/day + recipes based on vegetables poor in inulin-type fructans
干预措施: Placebo (Dietary Supplement)
Inulin
Experimental
16 g inulin/day + recipes based on vegetables rich in inulin-type fructans
干预措施: Inulin (Dietary Supplement)
结局指标
主要结局
Gut microbiota composition
时间窗: Month 0 - Month 3
Relative abundance (percent) of bacterial taxa will be assessed by 16S rRNA gene sequencing
次要结局
- Gut peptides(Month 0 - Month 3)
- Glucose homeostasis(Month 0 - Month 3)
- Hepatic fibrosis and/or steatosis(Month 0 - Month 3)
- Eating behavior(Month 0 - Month 3)
- Mood and emotional competence(Month 0 - Month 3)
- Anthropometry(Month 0 - Month 3)
- Dietary intake(Month 0 - Month 3)
- Cognition(Month 0 - Month 3)
- Metabolomics(Month 0 - Month 3)
- Physical activity(Month 0 - Month 3)
- Blood pressure(Month 0 - Month 3)
- Lipid homeostasis(Month 0 - Month 3)
- Biomarkers of systemic inflammation(Month 0 - Month 3)
研究者
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