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Completed

NCT Number: NCT03677583

Duckweed Intake Study

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duckweed

Other

various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce

Spinach

Other

various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce

Primary outcomes

  1. change in gastro-intestinal complaints

    Time frame: 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 outcomes

  1. change in blood hemoglobin

    Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake

    under fasting conditions

  2. change in blood glucose

    Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake

    under fasting conditions

  3. change in blood Fe (Iron)

    Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake

    under fasting conditions

  4. change in blood leukocyte cell counts

    Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake

    under fasting conditions

  5. change in blood ALAT

    Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake

    under fasting conditions

  6. change in blood GGT

    Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake

    under fasting conditions

  7. change in blood eGFR

    Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake

    under fasting conditions

  8. change in blood creatinine

    Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake

    under fasting conditions

  9. change in blood CRP

    Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake

    under fasting conditions

  10. change in blood zonulin

    Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake

    under fasting conditions

  11. change in urinary biomarkers of health

    Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake

    oxalic acid

  12. change in blood pressure

    Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake

    systolic and diastolic bloodpressure

Other outcomes

  1. fiber, fruit and vegetable intake

    Time frame: before the intervention (D=0), this questionaire provides insights in energy and macronutrient consumption

    via a food frequency questionaire

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Registry information

Official study title

Tolerance of Regular Intake of Duckweed Based Food Products

Acronym: DIS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 19, 2018
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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