Age-Related Memory Disorder, Atherosclerosis, Cognitive Decline, Hearing Loss, Inflammation, Vascular Disease
Conditions
Keywords
Folic acid, Atherosclerosis, Cognitive function, Hearing, Inflammation, Hemostasis, Arterial stiffness
Brief summary
The purpose of this study is to determine if folic acid supplementation can slow down atherosclerotic progression, age-related cognitive decline and age-related hearing loss.
Detailed description
Low levels of B vitamins, in particular folate, and high levels of plasma total homocysteine, have been associated with a variety of age-related diseases and disorders, including cardiovascular disease, dementia and hearing impairment. Extra folate, for example in the form of folic acid, is known to decrease the concentrations of plasma total homocysteine. We examined whether 0.8 mg/d folic acid could slow down atherosclerotic progression and the above mentioned age-related processes.
Interventions
BEHAVIORALfolic acid (0.8 mg)
Sponsors
Wageningen Centre for Food Sciences
ZonMw: The Netherlands Organisation for Health Research and Development
Wageningen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 50-70 years * Men and post-menopausal women * Women with a surgically removed uterus were required to be \>=55 years
Exclusion criteria
* Plasma total homocysteine \<13 or \>26 umol/L * Serum vitamin B12 \<200 pmol/L * Self-reported current use of drugs which affect folate metabolism * Self-reported current use of drugs believed to influence intima-media thickening, i.e., lipid-lowering drugs, hormone replacement therapy * Self-reported medical diagnosis of renal, intestinal, thyroid disease * Self-reported medical diagnosis of current cancer * Self-reported current use of supplements containing B vitamins * Self-reported inability or unwillingness to fast for 12 hours * \<80% compliance using placebo pills during a 6-week run-in period * Not giving written informed consent * Participation in other research studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean carotid intima-media thickness | — |
| Change in maximum carotid intima-media thickness | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in carotid distension | — |
| Change in hearing levels (pure tone air conduction averages of 0.5, 1, and 2 kHz & 4, 6 and 8 kHz) | — |
| Cognitive performance at year 3 (cognitive domains: simple speed, cognitive flexibility, and memory; and information processing speed and semantic memory) | — |
| Inflammatory markers and hemostasis markers | — |
Countries
Netherlands
Outcome results
None listed