Citicoline Effects on Cortical Membrane Structure and Function

Kyowa Hakko Bio

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Citicoline supplement

Dietary Supplement: Placebo supplement

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02705066

2015-8400

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.