The primary objective is to assess the post-prandial serum amino-acid profile of duckweed protein in healthy adult volunteers in comparison to a another plant-based high-protein crop: green pea. A secondary objective is to assess post-prandial…
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Brief title
Condition
- Other condition
Synonym
Health condition
Verteringskinetiek van eiwit bij gezonde mensen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the peak value and total amount of amino acids
measured in the serum before (t=0 min) and at the various time points after
consumption of the two proteins (until t=180 min).
Secondary outcome
Secondary outcomes are the glucose and insulin levels in the blood samples in
the same time period of three hours (t=0; t=15, t=30 * t=180) after consumption
of the two protein products. Aural temperature, heart rate and blood pressure
will be measured before (t=0 min) and after consumption (t=180 min). Finally,
subjects will report gastro-intestinal complaints on the test day (consumption
of the protein soup) and the subsequent three days via a diary.
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
protein to all humans, a transition towards more plant-based diets is required.
Duckweed seems an interesting alternative protein source due to its high
protein content and its enormous growth capacity. Duckweed has been used since
long as human food in Southeast Asian countries. Animal trials show that fresh
and dried duckweed can be fed successfully to various animals (fish, waterfowl,
chickens, cattle, sheep and goats) with good results on growth performance when
duckweed is part of their habitual diet. Because there is no information
available about the postprandial metabolism of duckweed in humans, the
Pro-2-study aims to study the amino acid profile and post-ingestive
consequences of duckweed protein (Lemnae minor) after a single intake with pea
protein as reference.
Study objective
The primary objective is to assess the post-prandial serum amino-acid profile
of duckweed protein in healthy adult volunteers in comparison to a another
plant-based high-protein crop: green pea. A secondary objective is to assess
post-prandial plasma glucose and insulin responses after a single intake of
duckweed protein in healthy adult volunteers in comparison with the reference
pea protein, as well as the acute health parameters heart rate, blood pressure
and aural temperature and the occurrence of gastro-intestinal complaints.
Study design
The Pro-2-study is designed as a randomized, cross-over trial. Subjects will
receive the two protein sources in randomized order with a washout period of
one week. The proteins will be offered in the form of a green soup with the two
products as similar as possible concerning appearance, texture and taste. The
study duration is two weeks, as one protein source is given at a time with an
interval of one week.
Intervention
Subjects come to the research facility in fasting state. After consuming the
soup (~550 ml with 20g of protein), blood samples will be taken each 15 minutes
for a period of three hours to assess the free amino acids as well as glucose
and insulin levels to get insight into the post-prandial metabolism of the two
plant proteins. Heart rate, blood pressure and aural temperature will be
measured before consumption (t=0 min) and three hours after consumption (t=180
min). During the test day and the subsequent three days, subjects will report
any gastro-intestinal discomfort and potential adverse effects to carefully
monitor any inconveniencies during the study.
Study burden and risks
The burden for participants in this study is relatively low. They have to visit
the research facility only twice within two weeks. Per test day, eleven blood
samples are drawn over a period of 195 minutes, for a total amount of 159 ml
blood, which is 32% of what is taken during blood donation (500ml within 15
minutes). Placing a catheter in a vein in the forearm for blood sampling can be
somewhat painful, it may lead to irritation, oedema and in exceptional cases,
inflammation may might occur. Participants may experience some level of burden
because of the overnight fast and some participants may experience a few
gastrointestinal inconveniences due to consumption of the plant-proteins.
The risks of participation are limited. The batch of duckweed that is going to
be used for the study, has been analysed thoroughly on several safety
parameters. Literature on animal trials with duckweed as feed do not show any
negative effects when duckweed is provided as part of their diet and human
consumption is common in certain areas of Asia; no reports exist of negative
consequences of duckweed consumption in these humans. The dose of duckweed (20
gram protein) provides about 25% of the current daily protein intake and it is
a single dose only. So, all together, no adverse effects are expected of this
single intake of duckweed. Nevertheless, heart rate, blood pressure and aural
temperature as well as potential gastro-intestinal consequences are assessed
during the study to carefully monitor any inconveniences. Routinely, AE*s and
SAE*s will be registered.
There are no direct benefits for the participants except that they receive
information about certain health parameters such as their blood pressure, heart
rate, fasting-glucose levels. Furthermore, they contribute to getting insight
into the nutritional value of alternative plant proteins. In this way, the
participants may contribute to the solution for a relevant societal challenge:
sufficient food for everyone in the world.
This study is not group related.
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
Inclusion criteria
* Healthy as assessed by a health and lifestyle questionnaire and normal blood clinical laboratory tests for haemoglobin, kidney and liver functioning
* Age between 18 and 50 y (boundaries included) at day 01 of the study
* Body mass index (BMI) between 19 and 25 kg/m2 (boundaries included)
* Appropriate veins for blood sampling (judged by a study nurse or medical doctor)
* Willing to abstain from blood donation one month before and during the study
* Willing to abstain from the use of protein supplements during the study period
* Signed informed consent
* Willing to comply with the study procedures
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 dysfynction (eGFR <60 ml/min)
* Any concomitant medication that may influence the study results, such as gastric acid inhibitors or laxatives (occasional use of paracetamol is allowed)
* Intensive sporting activities (>16 hours per week)
* Current smoker
* Alcohol intake *3 glasses of alcoholic beverages per day
* Pregnant or lactating or wishing to become pregnant in the period of the study (self-reported)
* Use of hard drugs
* Known allergies towards the products used in the study
* Not willing to consume chicken bouillon
* Participation in another clinical trial at the same time
* Being an employee of the department of Human Nutrition of Wageningen University or the 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 |
|---|---|
| Other | Nederlands trial register; voorlopige nummer 27390. Definitieve identificatienummer komt binnen 4 weken. |
| CCMO | NL62305.081.17 |