Duckweed Intake Study (DIS)

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Complication
• Intervention / Treatment: Other: Duckweed; Other: Spinach

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Stichting Wageningen Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Duckweed; daily lunch with 150-180g wet weight duck weed	Other: Duckweed; various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce
ACTIVE_COMPARATOR: Spinach; daily lunch with 150-180g wet weight spinach	Other: Spinach; various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in gastro-intestinal complaints	bloated feeling, belching, abdominal pain, flatulence, nausea, diarrhoea, constipation measured via Visual Analogue Scale (VAS)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in blood hemoglobin	under fasting conditions	before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood glucose	under fasting conditions	before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood Fe (Iron)	under fasting conditions	before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood leukocyte cell counts	under fasting conditions	before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood ALAT	under fasting conditions	before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood GGT	under fasting conditions	before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood eGFR	under fasting conditions	before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood creatinine	under fasting conditions	before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood CRP	under fasting conditions	before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood zonulin	under fasting conditions	before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in urinary biomarkers of health	oxalic acid	before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood pressure	systolic and diastolic bloodpressure	before (D=0) and after (D=11) 11 days of duckweed or spinach intake

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
fiber, fruit and vegetable intake	via a food frequency questionaire	before the intervention (D=0), this questionaire provides insights in energy and macronutrient consumption

Collaborators and Investigators

• Sponsor: Wageningen University and Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): October 14, 2018
• Study Completion (ACTUAL): October 15, 2018

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (ACTUAL): September 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NL66051.081.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No