Healthy
Conditions
Brief summary
The goal of this project is to determine the effects of 6-week dietary supplementation with one of two doses of citicoline (250 mg/d, 500 mg/d) or placebo on prefrontal cortical membrane dynamics (31P-MRS) and event-related functional activation (fMRI) in healthy middle-aged adults.
Detailed description
To determine the effect of citicoline supplementation on cortical structure and function in healthy middle-aged adults. Test 1: The effect of citicoline (500 mg/d) compared with placebo on event-related anterior cingulate cortex (ACC) activation during sustained attention by fMRI. Test 2: The effect of citicoline (500 mg/d) compared with placebo on reaction time and increasing accuracy on the sustained attention task (CPT-IP). Test 3: The effect of citicoline compared with placebo on phosphodiester (PDE) and b-NTP levels in the ACC by 31P-MRS. Test 4: ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS) following high-dose citicoline (500 mg/d) compared with placebo at Week 3. Test 5: The effect of low-dose citicoline (250 mg/d) compared with placebo on an ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS). Test 6: Among all subjects (n=60), the relationship between baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels and ACC activation, ACC PDE levels, or the effects of citicoline.
Interventions
DIETARY_SUPPLEMENTCiticoline supplement
DIETARY_SUPPLEMENTPlacebo supplement
Cellulose
Sponsors
University of Cincinnati
Kyowa Hakko Bio Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of written informed consent; * Ages 40-60 years old; * Right handed. * If female, not pregnant (as determined by a positive pregnancy test); and agrees to use one of the following methods of birth control: abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive;
Exclusion criteria
* Contraindication to an MRI scan (i.e., braces, claustrophobia, pacemaker etc); * A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy); * Body mass index (BMI) ≥ 30; * An IQ \<75 and \>130; * A positive urine drug test (nicotine dependence is permitted); * Personal history of a DSM-5 Axis I psychiatric disorder; * Requiring treatment with a drug which might obscure the action of the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phosphodiester (PDE) concentrations in the ACC by 31P-MRS | 6 weeks |
| b-NTP concentrations in the ACC by 31P-MRS | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Blood oxygenation level-dependent signal in the ACC during sustained attention by fMRI | 6 weeks |
| Reaction time (ms) on an attention task (CPT-IP) | 6 weeks |
| Accuracy (percent correct) on an attention task (CPT-IP) | 6 weeks |
Other
| Measure | Time frame |
|---|---|
| Baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels | Baseline |
Countries
United States
Outcome results
None listed