Interventional Study Comparing the Effect of a High-fiber Supplement Versus Placebo on the Body and the Brain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- fMRI BOLD activity during food wanting
研究概览
简要总结
The central research question aims to understand what drives individuals to make and maintain a vegan / vegetarian dietary decision, to investigate whether there are possible predictors that might influence such a decision and whether personality differences already exist or can only be measured after the change in diet. The investigators will examine the effects of a high-fiber diet on food wanting on a neural and on a behavioral level. The microbiome is suggested to mediate the expected changes in food wanting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •body-mass-index 25-30kg/m^2
- •females on contraception only
排除标准
- •current neurological or psychiatric illness
- •daily consumption of more than 50 g of alcohol, more than 10 cigarettes or more than 6 cups of coffee
- •use of antidepressants or other centrally acting drugs
- •type 2 diabetes mellitus or other serious metabolic disorders
- •MRI contraindication (e.g. cardiac pacemaker, drug pump, shunts)
- •major untreated medical condition, including gastrointestinal organs, lungs, heart, cardiovascular system, liver and kidney)
- •diet-related restrictions (food allergies, food intolerances, known nutrient deficiencies or a recent history of dieting or restrictive eating behaviour, including vegan, vegetarian diet)
- •current pregnancy or lactation
结局指标
主要结局
fMRI BOLD activity during food wanting
时间窗: 14 days
microbial alpha and beta diversity
时间窗: 14 days
The taxonomic structure of the microbial community will be determined using 16S rRNA gene sequencing. The reads from the sequencing data will be assigned to taxa by sequence similarity using puplic available data bases. Relative distribution of microbial taxa is then based on the number of reads assigned to each taxa. For the description of the the community the alpha diversity of each sample will be determined based on species richness, evenness of species distribution which is combined in the single value of the Shannon diversity index. Furthermore beta-diversity, how the microbial communities differ between sample, will be analysed by principal component analysis as well as non-metric multidimensional scaling. In addition, for each taxa significant difference between sample groups will be assessed by comparing the relative number of reads.
次要结局
- hunger hormones(14 days)
- positive and negative affect(14 days)
- mood(14 days)
- emotional health(14 days)
- satiety(14 days)
- fMRI BOLD activity memory performance(14 days)
- well-being(14 days)
- serum lipid metabolism markers(14 days)
- serum inflammatory markers(14 days)
- personality traits(14 days)
- serum microbial metabolic markers(14 days)
- gastrointestinal health(14 days)
- serum glucose metabolism markers(14 days)