Duckweed Intake Study (DIS)

Wageningen University and Research

Status

Completed

Conditions

Gastrointestinal Complication

Treatments

Other: Duckweed

Other: Spinach

Study type

Interventional

Funder types

Other

Identifiers

NCT03677583

NL66051.081.18

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Apparently healthy men and women
Age between 18 and 50 years
Body mass index (BMI) between 18.5 and 24.9 kg/m2

Exclusion criteria

Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease)
History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
Kidney dysfunction (self-reported)
Use of medication that may influence the study results, such as gastric acid inhibitors or laxatives
Reported slimming, medically prescribed or vegan/vegetarian diet
Current smokers
Alcohol intake ≥4 glasses of alcoholic beverages per day
Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
Abuse of illicit drugs
Food allergies for products that we use in the study
Participation in another clinical trial at the same time
Being an employee of the department Consumer Science & Health group of Wageningen Food & Biobased Research