Healthy
Conditions
Keywords
folic acid, folate, p-aminobenzoylglutamate, formiminoglutamate, homocysteine, experimental validation of a new biomarker
Brief summary
The major objective of the proposed study is to demonstrate the suitability of new markers for folate status in humans, which avoid blood sampling, as required for the established marker RBC folate concentration, but can be obtained from spot urine samples. For this reason urine and blood will be collected from volunteers, twice at baseline and in a subgroup after 6 and 12 weeks of intake of a folic acid supplement Specific hypotheses to be tested: Correlation study: * The 24 h urinary excretion of total p-ABG, as extrapolated via urinary creatinine concentration from the total p-ABG concentration in a spot sample is significantly correlated to RBC and plasma folate levels in the studied subjects * The 24 h urinary excretion of FIGLU, as extrapolated via urinary creatinine concentration form the FIGLU concentration in a spot sample is significantly correlated to RBC and plasma folate levels in the studied subjects Intervention study: Changes in folate status (RBC folate) after supplementary intake of folate result in increased urinary excretion of total p-ABG and FIGLU in subjects identified with a low folate status and in subjects identified with a high folate status among the study participants of the correlation study
Interventions
DIETARY_SUPPLEMENTfolic acid
0.4 mg of folic acid per day
Sponsors
European Union
Ludwig-Maximilians - University of Munich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* age: 18 - 45 years * apparently healthy * normal results on haematologic pattern and blood chemistry tests (according to university hospital reference values) * plasma vitamin B12 \> 160 pmol/l * no diagnosis of intestinal, renal or thyroid disease (self reported) * only male subjects will be enrolled but regular consumption of vitamin supplements (including folate) is not an exclusion criterium, as we aim to cover a wide range of folate concentrations.
Exclusion criteria
* recent (3 months) treatment with medication, assumed to interfere with folate status * abuse of alcohol or drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate | study day 1 |
Secondary
| Measure | Time frame |
|---|---|
| correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate | study day 42 |
Countries
Germany
Outcome results
None listed