Gastrointestinal ComplicationDISNCT03677583
Duckweed Intake Study
A study testing Duckweed and Spinach in people with Gastrointestinal Complication, run by Wageningen University and Research at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Complication
- What is being tested?
- Duckweed and Spinach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2018to 15 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy men and women
- Age between 18 and 50 years
- Body mass index (BMI) between 18.5 and 24.9 kg/m2
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrointestinal Complication
- Being tested
- Duckweed, Spinach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuckweedOther
various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce
SpinachOther
various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce
| Study group | Role | What they receive |
|---|---|---|
| Duckweed | Experimental | daily lunch with 150-180g wet weight duck weed Receives: Other: Duckweed |
| Spinach | Active comparator | daily lunch with 150-180g wet weight spinach Receives: Other: Spinach |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in gastro-intestinal complaints
bloated feeling, belching, abdominal pain, flatulence, nausea, diarrhoea, constipation measured via Visual Analogue Scale (VAS)
Measured: 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 outcomes (12)
change in blood hemoglobin
under fasting conditions
Measured: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood glucose
under fasting conditions
Measured: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood Fe (Iron)
under fasting conditions
Measured: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood leukocyte cell counts
under fasting conditions
Measured: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood ALAT
under fasting conditions
Measured: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood GGT
under fasting conditions
Measured: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood eGFR
under fasting conditions
Measured: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood creatinine
under fasting conditions
Measured: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood CRP
under fasting conditions
Measured: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood zonulin
under fasting conditions
Measured: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in urinary biomarkers of health
oxalic acid
Measured: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood pressure
systolic and diastolic bloodpressure
Measured: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start1 Oct 2018
- Primary completion14 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
- Investigators
- Diederik Esser, Dr, Principal investigator, Wageningen research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677583
- Sponsor's protocol ID
- NL66051.081.18
- Acronym
- DIS
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Regular Intake of Duckweed Based Food Products
- ClinicalTrials.gov ID
- NCT03677583
- Acronym / sponsor ID
- DIS / NL66051.081.18
- Conditions
- Gastrointestinal Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 14 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duckweed | Experimental | Other: Duckweeddaily lunch with 150-180g wet weight duck weed |
| Spinach | Active comparator | Other: Spinachdaily lunch with 150-180g wet weight spinach |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Apparently healthy men and women
- Age between 18 and 50 years
- Body mass index (BMI) between 18.5 and 24.9 kg/m2
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duckweedvarious meal products such as meal soup, quiche, mashed potato, curry and pasta sauce | Other | Duckweed |
| Spinachvarious meal products such as meal soup, quiche, mashed potato, curry and pasta sauce | Other | Spinach |
Primary outcome
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)
12 secondary outcomes
change in blood hemoglobin
Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood glucose
Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood Fe (Iron)
Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood leukocyte cell counts
Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood ALAT
Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood GGT
Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood eGFR
Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood creatinine
Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood CRP
Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood zonulin
Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in urinary biomarkers of health
Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
change in blood pressure
Time frame: before (D=0) and after (D=11) 11 days of duckweed or spinach intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Individual participant dataSharing planned: No. will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diederik Esser, Dr principal investigator
Wageningen research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duckweed and Spinach in people with Gastrointestinal Complication, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.