NCT05459662已完成不适用
A Randomized Cross-over Double Arm Control Trial Evaluating the Impact of the Daily Consumption of Plant-based Diversified Meal Over a 2 Weeks Period on the Adult Gut Microbiome
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年5月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Microbiota diversity & composition
研究概览
简要总结
The aim of this study is to evaluate the impact of a diversified plant-based meal on the gut microbiome and its composition.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-55 years,
- •Healthy participants, both male and female,
- •BMI in the normal and overweight range 18.5 ≤ BMI ≤ 29.9 kg/m2,
- •Able to understand and to sign a written informed consent prior to study enrolment.
排除标准
- •Known chronic diseases or conditions for which the investigators/investigation team deem as not suitable for study participation,
- •Known food allergy and intolerance e.g. lactose intolerance, nuts allergy,
- •Habitually, have < 5 spontaneous bowel movements on average per week,
- •Chronic or recurrent diarrhoea with spontaneous bowel movements > 2 per day
- •Prior gastrointestinal surgery (apart from appendectomy or herniotomy),
- •Received systemic antiviral/antibacterial/antifungal therapy during the 3 months prior to study enrolment,
- •Medications or supplements that are known to alter gut function or microflora i.e. acid antisecretory drugs, pre-/probiotics, laxative during the 4 weeks prior to study enrolment,
- •Anti-hyperlipidaemic, antihypertensive medications and/or anticoagulant agents,
- •Currently participating in another interventional clinical trial or research project,
- •Alcohol intake > 2 servings per day; specifically, a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. Or other chronic substance abuse,
- •Changing diet patterns due to travelling and staying abroad for more than two weeks (Asia, Africa, or Latin America) during the two months prior to study enrolment,
- •Food restrictions such as vegan, vegetarian, ketogenic, low carb, paleo, raw diets, caloric restrictive diets,
- •Artificially sweetened beverage intake >1000 ml/ per day,
- •Female participants will be excluded if they are pregnant, have given birth in the last 6 months, or are lactating,
- •Subject having a hierarchical or family link with the research team members,
- •Occurrence of fever episodes, infection, or vaccination during 14 days before the start of the study.
结局指标
主要结局
Microbiota diversity & composition
时间窗: Throughout 14 days of product intake
Measured by Next Generation Sequencing (NGS)
次要结局
- Change in Short Chain Fatty Acids (SCFA) in the stool(Throughout 14 days of product intake)
- Gastrointestinal Symptom Rating Scale (GSRS)(Throughout 14 days of product intake)
- Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey)(Throughout 14 days of product intake)
研究者
研究点 (2)
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