Tolerance of Regular Intake of Duckweed Based Food Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- change in gastro-intestinal complaints
研究概览
简要总结
The study aims to study the impact of frequent intake of 150-180 gram duckweed on gastrointestinal complaints and several other health related biomarkers. The study has a randomised parallel design. Two different treatments will be evaluated e.g. a 11-day intervention with duckweed based meals and a 11-day intervention with control/spinach meals. At the start and at the end of the intervention we will collect a blood sample and a urine samples. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.
详细描述
The study aims to study the impact of frequent intake of 150-180 gram duckweed on gastrointestinal complaints and several other health related biomarkers.
Objective
The primary objective is to investigate gastro-intestinal complaints during 11 day duckweed consumption. Secondary objectives are to assess blood based parameters related to general health and urine based biomarkers for kidney function and to investigate consumer acceptance.
Study design: The study has a randomised parallel design. Two different treatments will be evaluated e.g. a 11-day intervention with duckweed based meals and a 11-day intervention with control/spinach meals. At the start and at the end of the intervention we will collect a blood sample and a urine samples. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.
Study population: We aim to include 24 healthy volunteers aged 18-50 years. Intervention: A 11-day intervention in which subjects will receive a daily lunch with 150-180g wet weight duck weed or spinach. Products will be incorporated in food products such as pasta, curry, soup etc.
Main study parameters/endpoints: The main study parameter is frequency and severity of gastro-intestinal complaints. Secondary outcomes are intestinal health parameters derived from blood and urine samples taken before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Spinach
daily lunch with 150-180g wet weight spinach
干预措施: Spinach (Other)
Duckweed
daily lunch with 150-180g wet weight duck weed
干预措施: Duckweed (Other)
结局指标
主要结局
change in gastro-intestinal complaints
时间窗: Daily, during 11 days of duckweed intake and up to three days after intake. By questionnaires and Visual Analogue Scale (VAS) scores; from no complains (minimal) to serious complains (maximum)). Higher values represent a worse outcome
bloated feeling, belching, abdominal pain, flatulence, nausea, diarrhoea, constipation measured via Visual Analogue Scale (VAS)
次要结局
- change in blood hemoglobin(before (D=0) and after (D=11) 11 days of duckweed or spinach intake)
- change in blood glucose(before (D=0) and after (D=11) 11 days of duckweed or spinach intake)
- change in blood Fe (Iron)(before (D=0) and after (D=11) 11 days of duckweed or spinach intake)
- change in blood leukocyte cell counts(before (D=0) and after (D=11) 11 days of duckweed or spinach intake)
- change in blood ALAT(before (D=0) and after (D=11) 11 days of duckweed or spinach intake)
- change in blood GGT(before (D=0) and after (D=11) 11 days of duckweed or spinach intake)
- change in blood eGFR(before (D=0) and after (D=11) 11 days of duckweed or spinach intake)
- change in blood creatinine(before (D=0) and after (D=11) 11 days of duckweed or spinach intake)
- change in blood CRP(before (D=0) and after (D=11) 11 days of duckweed or spinach intake)
- change in blood zonulin(before (D=0) and after (D=11) 11 days of duckweed or spinach intake)
- change in urinary biomarkers of health(before (D=0) and after (D=11) 11 days of duckweed or spinach intake)
- change in blood pressure(before (D=0) and after (D=11) 11 days of duckweed or spinach intake)
研究者
Diederik Esser
project leader clinical trials
Wageningen University and Research