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临床试验/NCT06082778
NCT06082778进行中(未招募)不适用

Eating Alive: ZOE's Ferment Experiment

Zoe Global Limited2 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2023年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50,000
试验地点
2
主要终点
Daily energy level

研究概览

简要总结

It is not known if an increase in fermented food intake relative to an individuals' habitual diet can lead to improvements in bloating, mood, or hunger levels, or increase energy levels (and reduce fatigue) in the general population. Acceptability of fermented foods across many different types of people and households is also unclear. Therefore, this research aims to investigate the potential effects of increasing fermented food intake on these outcomes, as well as the feasibility of this dietary change.

详细描述

Background:

Fermented foods (e.g., kombucha, kimchi, sauerkraut) are living foods containing an ecosystem of bacteria and yeasts that use enzymes to process and transform food components. The process of fermentation results in an enhanced nutritional profile of these foods (including probiotics, prebiotics, and additional vitamins) which are associated with health benefits. The majority of people in the Western world consume low amounts of fermented food with live cultures; ~70% report never or rarely consuming fermented foods.

Existing research demonstrates that there are benefits to consuming fermented foods, including improvement of gut microbiome composition as well as reducing inflammation. Furthermore, fermented foods are a unique source of B vitamins that are related to energy levels. Low energy levels are a common but complex problem that affects healthy individuals as well as those with chronic health conditions. Whilst the underlying causes of low energy are unclear, they are a common complaint of many digestive disorders, autoimmune, chronic inflammatory conditions, and metabolic and mood disorders, all of which are associated with disturbance of the gut microbiome. Humans are unable to produce B vitamins and are reliant on diet or gut microbes to produce them. Vitamin B12 levels are ten fold greater in fermented dairy products, and can be found in fermented plant-based foods such as tempeh, making these foods a valuable source of vitamin B12, a nutrient that the human diet is commonly deficient in. Fermented foods may have the potential to improve energy, and mood, by increasing gut diversity and reducing inflammation.

Population:

This research is open to participants who are enrolled in the ZOE Health Study. Participants must be at least 18 years of age and must provide their consent in order to participate.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adults aged 18
  • Able to give informed consent
  • Are participants of the ZOE Health Study
  • Reside in the UK.

排除标准

  • Participants will be excluded if they are:
  • Below the age of 18 years.
  • Have an histamine intolerance.
  • Have a compromised immune system.
  • Have been instructed to follow a salt-restricted diet.
  • Consume 8 or more portions of fermented foods on a daily basis at baseline

结局指标

主要结局

Daily energy level

时间窗: 3 weeks

Participants will self-report their energy level daily using a Visual Analogue Scale ranging from 0 to 10. Higher scores represent better outcomes.

次要结局

  • Daily sensation of abdominal bloating(3 weeks)
  • Change in hunger level(3 weeks)
  • Change in mood(3 weeks)
  • Daily level of mood(3 weeks)
  • Daily hunger level(3 weeks)

研究者

发起方
Zoe Global Limited
申办方类型
Other
责任方
Sponsor

研究点 (2)

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