Objective: The primary objective is to investigate the digestibility of isolated duckweed protein and the isolated benchmark protein whey.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
vertering
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is blood amino acids measured before and after
consumption of 20 g protein.
Secondary outcome
The secondary study parameter is blood glucose and insulin measured before and
after consumption of 20 g protein.
Background summary
Rationale: 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. Duckweed (Lemnae minor) seems an interesting
alternative protein source due to its high protein content and its enormous
growth capacity. Last two years we conducted two human trials on duckweed to
test the digestibility (METC 17/13) and tolerance (METC 18/15) of duckweed
plant material. In the Pro-2 study (METC nr 17/13) we observed that plant
material is poorly digested and postprandial amino acids were only minimally
increased after duckweed consumption. Isolated proteins from duckweed may
therefore better qualify as an alternative protein source. Therefore, the study
aims to study the digestibility of isolated duckweed protein. The digestibility
of the isolated duckweed protein will be compared to an isolated benchmark
protein whey.
Study objective
Objective: The primary objective is to investigate the digestibility of
isolated duckweed protein and the isolated benchmark protein whey.
Study design
Study design: The study is a cross-over, double blind, controlled trial in
which study participants will visit the research facility on two occasions
under fasting conditions. Subjects will receive two protein sources in
randomized order with a washout period of one week. Blood will be collected via
a catheter before and up-to 3 hours after protein consumption.
Intervention
Intervention: Study participants will receive 20 grams of isolated duckweed
protein and the isolated benchmark protein whey.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: 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. Also the Pro-2 study and the DIS-study indicated no extra
gastro intestinal complaints, even after consumption of a very large dose of
plant material (550 gram). The total amount of blood collected during the study
is low and therefore not expected to cause any problems. Participants cannot
participate if they have aenemia. Blood collection via a catheter may cause
some discomfort and a bruise. Study subjects that will participate in the study
will invest approximately 12 hours during the trial and need to visit the
research facility on two occasions.
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
Inclusion criteria
* healthy men and women
* Age between 18 and 50 years
* Body mass index (BMI) between 18 and 25 kg/m2
* Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor)
Exclusion criteria
* Any metabolic, gastrointestinal, inflammatory or other 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)
* Anemea (Hb values<7.5 for women and <8.5 for men)
* Use of medication that may influence the study results, such as gastric acid inhibitors, laxatives, stomach protectors and drugs that can affect intestinal motility
* Reported slimming, medically prescribed, vegan/vegetarian or other extreme diets or the use of protein supplements
* Not willing to give up blood donation during the study
* 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 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 |
|---|---|
| ClinicalTrials.gov | NCT03823222 |
| CCMO | NL66859.081.18 |