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Duckweed Intake Study (DIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Complication Other: Duckweed Other: Spinach Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tolerance of Regular Intake of Duckweed Based Food Products
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : October 14, 2018
Actual Study Completion Date : October 15, 2018

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677583


Locations
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Netherlands
Stichting Wageningen Research
Wageningen, Gelderland, Netherlands, 6708 WG
Sponsors and Collaborators
Wageningen University and Research
Investigators
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Principal Investigator: Diederik Esser, Dr Wageningen research

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Responsible Party: Diederik Esser, project leader clinical trials, Wageningen University and Research
ClinicalTrials.gov Identifier: NCT03677583     History of Changes
Other Study ID Numbers: NL66051.081.18
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No