Effect of the Sustainable Diet on Gut Microbiota and the Metabolome: a Randomised Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Gut microbiota changes
研究概览
简要总结
Unhealthy diets are closely linked to non-communicable diseases and constitute higher risk of morbidity and mortality than unsafe sex, alcohol, tobacco and drugs use combined. According to the World Health Organization (WHO), a healthy diet follows a plant-based pattern with low quantities of red meat and a low simple sugar intake. It would also reduce anthropological ecologic impact. We hypothesize that a plant-based diet will beneficially modify the gut microbiota and metabolome, influencing also Trimethylamine N-oxide (TMAO), a metabolite associated to CVD.
This study has a randomized single blind crossover design that compares a plant-based diet towards a control western diet. It is applied to volunteers aged 18-70 years, N=20. Each dietary intervention (plant-based and western) would last for 16 consecutive days separated by a minimum of 7 weeks washout period (intervention 1-washout-intervention 2). Samples of blood urine and faeces will be collected at day 1 and 14 of each intervention. On day 14 will be performed L-carnitine challenge with 1200mg of L-carnitine to test the levels of TMAO), in for the next 2 consecutive days (24h and 48h post treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Single-blind
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Free-living, apparently healthy adults
- •Aged 18-70 years at recruitment
- •Non-smokers
- •Exclusion criteria:
- •Non-free-living adults
- •Adults <18 or >70 years at recruitment
- •Current smokers
排除标准
- 未提供
结局指标
主要结局
Gut microbiota changes
时间窗: Change over 14 days
Significant changes in the number of bifidobacteria
Quantification of Trimethylamine N-oxide
时间窗: Day 16
Changes in response to L-Carnitine challenge
次要结局
- Bioactivity of faecal water(Change over 14 days)
- Effects on inflammatory markers of both diets(Change over 14 days)
- Ex vivo effects of faecal water on gut pathobionts(Day 14)
- Quantification of phytochemicals(Change over 14 days)
- Quantification of Short Chain Fatty Acids (SCFA)(Change over 14 days)
