Characterizacion of Pro-VEgetarian Diets: Diet Quality and Nutrition, MIcrobial/Metabolite Profiles and Implications in CAncer (MIVECA Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Dietary habits obtention from vegetarians: the dietary intake
研究概览
简要总结
This projects aims to characterize dietary habits and nutrition quality of pro-vegetarian diets as compared to omnivorous diets. It also aims to stablish gut microbial and metabolit profiles of this dietary pattern, in order to elucidate the role of plant-based diets in cancer prevention and treatment.
详细描述
Plant-based foods (fruits, vegetables, cereals, nuts and seeds, legumes, and vegetable oils) are the main source of fiber and other bioactive compounds in the diet. Plant-based diets are therefore assumed to prevent mortality and the ocurrence of chronic diseases including cancer. However, evidence on this issue is still scarce, and the mechanisms and drivers of their potential health benefits are also only partially known.
The main objectices of this project are:
- To develop and validate dietary assessment methods for the vegetarian population
- To assess dietary habits and consumer beliefs of vegetarians with respect to omnivores, considering different types of vegetarian diets
- To identify a gut microbiota signature related to plant-based diets from subgroups of subjects following a plant-based diet foods (vegans, lacto-vegetarians, ..., and pro-vegetarians) and omnivorous subjects (non-plant-based diets), from stool metagenomic sequencing.
- To relate this signature with metabolites present in faeces (related to the presence of certain microbial species) and in urine to improve the predictive capacity of the microbial signature of vegetable diets.
- Validate the signature using independent study populations, and including colorectal and breast cancer survivors as another study target.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •pregnancy or lactation
- •antibiotic treatment in the previous 2 weeks
结局指标
主要结局
Dietary habits obtention from vegetarians: the dietary intake
时间窗: 3 months
Dietary habits will be taken by an online specific Food Frequency Questionnaire (FFQ) for Spanish population, including novel vegetarian foods to evaluate vegetarian food consumption. The data analysis will be taken at baseline outcome.
Dietary assessment validation methods: 24-hour-recalls and dietary intake biomarkers
时间窗: 6 monts
To validated dietary assessment method, two 24-Hour-Recalls in two non-consecutive days will be used, as well as the analysis of specific vegetarian diet metabolites in urine and stool samples using Ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS). The data analysis will be taken at baseline. We have estimated that 200 subjects will be sufficient to detect, with a 95% confidence and power of 90%, correlation coefficients greater than rho=0.2.
次要结局
未报告次要终点
研究者
Esther Molina-Montes
Professor (Assistant)
Universidad de Granada
