In this pilot study, the time course of the increase in blood plasma levels of uridine after single intake of UMP and UMP-enriched products will be explored in healthy volunteers. Five intervention groups will be studied; three intervention groups…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Uridine bloedbeeld na uridine monofosfaat inname
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in blood plasma levels of uridine over time, following single intake of
study product.
Secondary outcome
N.a.
Background summary
Uridine monophosphate (UMP) is a nucleotide that is a normal constituent of
Ribonucleic acid (RNA), the molecules responsible for the proteins in the human
body. RNA is present in all living cells and therefore in the human diet. Foods
rich in RNA, such as sardines, yeast and some organ meats (like liver) will
provide significant quantities of UMP. Upon digestion of UMP-containing food,
UMP is hydrolysed to uridine by splitting off the phosphate group. Uridine is a
normal metabolite in the cells of plants and animals and therefore also present
in daily diet.
This exploratory study is an initial investigation that may generate
information (e.g. the influence of UMP dosage on blood uridine levels, the most
appropriate timing of blood sampling after intake of UMP enriched products in
order to detect blood uridine levels) that will be valuable for the development
of new nutritional product concepts (e.g. to reduce ingredient costs) and for
the design of a larger powered randomised prospective clinical study, in which
subjects will take UMP-enriched products for longer duration and in which
(blood) biomarkers will be studied more extensively.
Due to the exploratory nature of the study and the absence of information with
which to calculate the required group-size, no sample size calculation was done
for this study.
Study objective
In this pilot study, the time course of the increase in blood plasma levels of
uridine after single intake of UMP and UMP-enriched products will be explored
in healthy volunteers. Five intervention groups will be studied; three
intervention groups will receive the multi-nutrient product containing
different UMP dosages. The fourth intervention group will receive a UMP
supplement and the control group will receive a multi-nutrient product without
UMP.
Study design
This will be an open, placebo controlled study. The study duration per subject
is 1 day. A total of 25 subjects will be enrolled in 1 study site in the
Netherlands.
Intervention
All subjects will undergo a single intake of 125ml of the allocated study
product during the study visit, and have blood sampled to determine uridine
levels.
Study burden and risks
There are no known undesirable effects after intake of the study product. Of
the study procedures, blood sampling may cause bruising, pain and stiffness,
infection and flebitis.
Postbus 7005
6700 CA Wageningen
NL
Postbus 7005
6700 CA Wageningen
NL
Listed location countries
Age
Inclusion criteria
-Male
-Age 50-70 years, inclusive
-BMI 18- 28kg/m2, inclusive
-Written informed consent
Exclusion criteria
-Any condition that may interfere with the definition *healthy volunteer* according to the investigator, with special attention to the presence of liver disease, bowel disease, diarrhea and catabolism (unintended recent weight loss)
-Heavy exercise like long-distance running one week prior to the study day
-The use of RNA rich nutritional supplements (such as yeast) within a period of one month prior to the start of the study
-Unable to adhere to protocol instructions
-Alcohol or drug abuse in the opinion of the investigator
-Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
-Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
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 | NL35909.072.11 |