NCT02705066

Citicoline Effects on Cortical Membrane Structure and Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Kyowa Hakko Bio Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Citicoline supplement
DIETARY_SUPPLEMENT	Placebo supplement	Cellulose

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2016-03-10
• Last updated: 2019-05-23

Locations

1 site across 1 country: United States