Duckweed Intake Study
- Conditions
- Gastrointestinal Complication
- Interventions
- Other: DuckweedOther: Spinach
- Registration Number
- NCT03677583
- Lead Sponsor
- Wageningen University and Research
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Duckweed Duckweed daily lunch with 150-180g wet weight duck weed Spinach Spinach daily lunch with 150-180g wet weight spinach
- Primary Outcome Measures
Name Time Method change in gastro-intestinal complaints 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)
- Secondary Outcome Measures
Name Time Method change in blood hemoglobin before (D=0) and after (D=11) 11 days of duckweed or spinach intake under fasting conditions
change in blood glucose before (D=0) and after (D=11) 11 days of duckweed or spinach intake under fasting conditions
change in blood Fe (Iron) before (D=0) and after (D=11) 11 days of duckweed or spinach intake under fasting conditions
change in blood leukocyte cell counts before (D=0) and after (D=11) 11 days of duckweed or spinach intake under fasting conditions
change in blood ALAT before (D=0) and after (D=11) 11 days of duckweed or spinach intake under fasting conditions
change in blood GGT before (D=0) and after (D=11) 11 days of duckweed or spinach intake under fasting conditions
change in blood eGFR before (D=0) and after (D=11) 11 days of duckweed or spinach intake under fasting conditions
change in blood creatinine before (D=0) and after (D=11) 11 days of duckweed or spinach intake under fasting conditions
change in blood CRP before (D=0) and after (D=11) 11 days of duckweed or spinach intake under fasting conditions
change in blood zonulin before (D=0) and after (D=11) 11 days of duckweed or spinach intake under fasting conditions
change in urinary biomarkers of health before (D=0) and after (D=11) 11 days of duckweed or spinach intake oxalic acid
change in blood pressure before (D=0) and after (D=11) 11 days of duckweed or spinach intake systolic and diastolic bloodpressure
Trial Locations
- Locations (1)
Stichting Wageningen Research
🇳🇱Wageningen, Gelderland, Netherlands