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临床试验/NCT05231317
NCT05231317已完成不适用

Effect of the Sustainable Diet on Gut Microbiota and the Metabolome: a Randomised Crossover Study

University of Ulster2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年7月2日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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