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Duckweed Intake Study (DIS)

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ClinicalTrials.gov Identifier: NCT03677583
Recruitment Status : Completed
First Posted : September 19, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Diederik Esser, Wageningen University and Research

Tracking Information
First Submitted Date  ICMJE September 6, 2018
First Posted Date  ICMJE September 19, 2018
Last Update Posted Date October 22, 2018
Actual Study Start Date  ICMJE October 1, 2018
Actual Primary Completion Date October 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03677583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
  • change in blood hemoglobin [ Time Frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake ]
    under fasting conditions
  • change in blood glucose [ Time Frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake ]
    under fasting conditions
  • change in blood Fe (Iron) [ Time Frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake ]
    under fasting conditions
  • 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
  • change in blood ALAT [ Time Frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake ]
    under fasting conditions
  • change in blood GGT [ Time Frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake ]
    under fasting conditions
  • change in blood eGFR [ Time Frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake ]
    under fasting conditions
  • change in blood creatinine [ Time Frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake ]
    under fasting conditions
  • change in blood CRP [ Time Frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake ]
    under fasting conditions
  • change in blood zonulin [ Time Frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake ]
    under fasting conditions
  • change in urinary biomarkers of health [ Time Frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake ]
    oxalic acid
  • change in blood pressure [ Time Frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake ]
    systolic and diastolic bloodpressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 18, 2018)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Duckweed Intake Study
Official Title  ICMJE Tolerance of Regular Intake of Duckweed Based Food Products
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Gastrointestinal Complication
Intervention  ICMJE
  • Other: Duckweed
    various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce
  • Other: Spinach
    various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce
Study Arms  ICMJE
  • Experimental: Duckweed
    daily lunch with 150-180g wet weight duck weed
    Intervention: Other: Duckweed
  • Active Comparator: Spinach
    daily lunch with 150-180g wet weight spinach
    Intervention: Other: Spinach
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 15, 2018
Actual Primary Completion Date October 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03677583
Other Study ID Numbers  ICMJE NL66051.081.18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: will not be shared
Responsible Party Diederik Esser, Wageningen University and Research
Study Sponsor  ICMJE Wageningen University and Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Diederik Esser, Dr Wageningen research
PRS Account Wageningen University and Research
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP