Clinical trial NCT02705066: Citicoline Effects on Cortical Membrane Structure and Function
Official title: Citicoline Effects on Cortical Membrane Structure and Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Kyowa Hakko Bio Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of Cincinnati
First posted: 2016-03-10
Enrollment: 61
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Phosphodiester (PDE) concentrations in the ACC by 31P-MRS
timeFrame: 6 weeks
measure: b-NTP concentrations in the ACC by 31P-MRS
timeFrame: 6 weeks
Secondary outcomes:
measure: Blood oxygenation level-dependent signal in the ACC during sustained attention by fMRI
timeFrame: 6 weeks
measure: Reaction time (ms) on an attention task (CPT-IP)
timeFrame: 6 weeks
measure: Accuracy (percent correct) on an attention task (CPT-IP)
timeFrame: 6 weeks
Other outcomes:
measure: Baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels
timeFrame: Baseline
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
References: