Gastrointestinal Complication Clinical Trial
Official title:
Tolerance of Regular Intake of Duckweed Based Food Products
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.
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.
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