he primary objective is to investigate gastro-intestinal complains 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…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal disorders
Synonym
Health condition
overige gezondheidsparameters
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter frequency and severity of gastro-intestinal complains.
Secondary outcome
Secondary outcome are intestinal health parameters derived from blood and urine
samples taken before and after the intervention. And scores on consumer
acceptence
Background summary
The rapid population growth and increasing standards of living are leading to
an increasing demand for animal-derived protein. In order to provide sufficient
dietary protein for human consumption, a transition towards more plant-based
diets is required. Eendenkroos (Lemna minor) seems an interesting alternative
protein source due to its high protein content and its enormous growth
capacity. Last year we conducted a human trial in which we investigated the
postprandial impact of a large portion (550 gram) Duckweed plant material on
blood amino acids (AA). However, before duckweed can be a included in a western
diet, we need to investigate whether frequent intake of duckweed plant
material, as part of a normal diet, would have effects on intestinal function
and discomfort and investigate consumer acceptance. Therefore, the DISS-study
aims to study the impact of frequent intake of 150-180 gram duckweed on
gastrointestinal complains and several other health related biomarkers.
Study objective
he primary objective is to investigate gastro-intestinal complains 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 complains, stool consistency and frequency, wellbeing, health
complains or other adverse effects will be collected daily during intervention
and up to two days after the intervention.
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.
Study burden and risks
This study is not related to a specific group. There are minor risks for the
participants of this study. There are no direct benefits for the participants.
The batch of duckweed that is going to be used for the study, has been analysed
thoroughly on several safety parameters and no harm is expected. Literature
about the use of duckweed as animal feed shows that fresh and dried duckweed
has been fed successfully, indicating that duckweed can be part of the diet
without adverse effects. Human consumption of duckweed is common in certain
areas of Asia. Also the Pro-2 study indicated no extra gastro intestinal
complaints after consumption of a very large dose (550 gram). Still due to its
hard digestibility, consumption of duckweed may cause minor gastrointestinal
discomfort, especially in the first few days of the intervention. The total
amount of blood collected during the study is low and therefore not expected to
cause any problems. Study subjects that will participate in the study will
invest approximately 25 hours during the trial and need to visit the research
facility daily during working days.
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
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
* 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 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66051.081.18 |