Gastrointestinal Complication
Conditions
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.
Interventions
Sponsors
Wageningen University and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in gastro-intestinal complaints | 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
| Measure | Time frame | Description |
|---|---|---|
| change in blood hemoglobin | before (D=0) and after (D=11) 11 days of duckweed or spinach intake | under fasting conditions |
| change in blood glucose | before (D=0) and after (D=11) 11 days of duckweed or spinach intake | under fasting conditions |
| change in blood Fe (Iron) | before (D=0) and after (D=11) 11 days of duckweed or spinach intake | under fasting conditions |
| change in blood leukocyte cell counts | before (D=0) and after (D=11) 11 days of duckweed or spinach intake | under fasting conditions |
| change in blood ALAT | before (D=0) and after (D=11) 11 days of duckweed or spinach intake | under fasting conditions |
| change in blood GGT | before (D=0) and after (D=11) 11 days of duckweed or spinach intake | under fasting conditions |
| change in blood creatinine | before (D=0) and after (D=11) 11 days of duckweed or spinach intake | under fasting conditions |
| change in blood CRP | before (D=0) and after (D=11) 11 days of duckweed or spinach intake | under fasting conditions |
| change in blood zonulin | before (D=0) and after (D=11) 11 days of duckweed or spinach intake | under fasting conditions |
| change in urinary biomarkers of health | before (D=0) and after (D=11) 11 days of duckweed or spinach intake | oxalic acid |
| change in blood pressure | before (D=0) and after (D=11) 11 days of duckweed or spinach intake | systolic and diastolic bloodpressure |
| change in blood eGFR | before (D=0) and after (D=11) 11 days of duckweed or spinach intake | under fasting conditions |
Other
| Measure | Time frame | Description |
|---|---|---|
| fiber, fruit and vegetable intake | before the intervention (D=0), this questionaire provides insights in energy and macronutrient consumption | via a food frequency questionaire |
Countries
Netherlands
Outcome results
None listed