NCT02705066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

May 23, 2019

Status Verified

February 1, 2019

Enrollment Period

2.3 years

First QC Date

February 23, 2016

Last Update Submit

May 21, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Phosphodiester (PDE) concentrations in the ACC by 31P-MRS

    6 weeks

  • b-NTP concentrations in the ACC by 31P-MRS

    6 weeks

Secondary Outcomes (3)

  • 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 Outcomes (1)

  • Baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels

    Baseline

Study Arms (3)

Placebo (Cellulose)

PLACEBO COMPARATOR
Dietary Supplement: Placebo supplement

Cognizin 250 mg/day

EXPERIMENTAL
Dietary Supplement: Citicoline supplement

Cognizin 500 mg/day

EXPERIMENTAL
Dietary Supplement: Citicoline supplement

Interventions

Citicoline supplementDIETARY_SUPPLEMENT
Also known as: Cognizin
Cognizin 250 mg/dayCognizin 500 mg/day
Placebo supplementDIETARY_SUPPLEMENT

Cellulose

Also known as: Placebo
Placebo (Cellulose)

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 10, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

May 23, 2019

Record last verified: 2019-02

Locations

US(1)