The objective of the study is to investigate the bioequivalence of Urd bioavailability in healthy elderly after bolus intake of oral UMP versus oral Urd.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
dit is een bioequivalentie onderzoek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameters in this study are Urd AUC [µmol/L*min] and Cmax
[µmol/L] (product B versus A).
Secondary outcome
The secondary outcome parameters in this study are Urd AUC [µmol/L*min] and
Cmax [µmol/L] (product D vs. C), Tmax [min] and t* AUC [min] (product B vs A,
D vs. C), Urd AUC [µmol/L*min], Cmax [µmol/L], Tmax [min] and t* AUC [min] (A
vs. E, B vs. E, C vs. E, D vs. E).
Background summary
UMP is an element of RNA that is involved in the production of proteins in the
body. RNA (and thus also UMP) are located in all body cells and it is present
in our daily diet.
Urd is a nucleotid and a normal breakdown product in cells of plants and
animals and thus also present in our daily diet.
The current study will investigate the bioequivalence of Urd bioavailability in
healthy elderly after bolus intake of oral UMP versus oral Urd.
Study objective
The objective of the study is to investigate the bioequivalence of Urd
bioavailability in healthy elderly after bolus intake of oral UMP versus oral
Urd.
Study design
This is a randomised, placebo-controlled, double-blind, crossover,
single-centre study
Intervention
The subjects will be randomly allocated to receive five study products in a
pre-specified order on 5 different days:
2 times a dosage of UMP, 2 times a dosage of uridine and 1 time a placebo
Study burden and risks
There are no known undesirable effects after intake of the study products.
There are no special benefits for the subjects.
Expected risks associated with the protocol are minimal. No noticeable effects
are expected, except for known side effects of blood collections by a cannula,
i.e. the risk of formation of a small hematoma.
Subjects will receive a reasonable compensation per completed study visit. The
compensation includes the costs related to travelling to the study centre.
Subjects will receive one meal during Visit 1 to 5.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
- Age 60 years or older
- BMI from 20 through 30 kg/m2
- Willingness and ability to comply with the protocol
- 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 and renal disease, diabetes mellitus, Alzheimer, diarrhea, obstipation and known severe weight loss (> 3 kg in last 3 months)
- Any gastrointestinal (GI) disease or surgery that interferes with GI function
- (History of) any cancer with the exception of basal cell carcinoma
- Any sign of inflammation in the last 7 days prior to Visit 1
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 | NL51510.056.15 |