Citicoline, Creatine, and Omega-3 Effects in Middle Age Women

NCT01502813 | Completed Results DMC

• 1 other identifier: IRB_48136
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the functional effects of a citicoline, creatine, and omega-3 fatty acids combination when administered for a duration of four weeks (28 days) to non-psychiatric adult female participants.

Conditions

Cognitive Benefits

Keywords

Neuropsychological testing; Dietary supplements

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in California Verbal Learning Test (CVLT) That Measure Attention and Memory at 14 Days

  List B in the California Verbal Learning Test (CVLT) score range 1-16; the score is the number of words recalled so higher scores = better performance/more words recalled.

  Baseline and 14 days from baseline

• Change From Baseline in WAIS-IV Block Design Subtest A That Measures Attention and Memory at 28 Days

  WAIS-IV Block Design Subtest A test of visuoconstructional ability is recognized as a test of visuospatial planning and function. It has been shown to be correlated with measures of general intellectual ability. The score range for this measure is 0-129. A score of 90-110 is average for a standard score. The higher the score the better the outcome.

  Baseline and 28 days from baseline

Study Arms (1)

Citicoline, Creatine, and Omega-3 Arm

EXPERIMENTAL

Each participant will be given a supplement log at the end of visit 1. They will be asked to complete the log during the 28 days to indicate that the daily dose of supplements were taken according to instructions. The study coordinator will check the log on the second and third visits as well as count the remaining supplement pills. If participants do not comply with the daily supplement schedule, then the PI will determine if the participant should be withdrawn from the study.

Drug: Citicoline, Omega-3 Fatty Acids and Creatine

Interventions

Citicoline, Omega-3 Fatty Acids and Creatine DRUG

Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days

Also known as: CDP-Citicoline, Creatine monohydrate

Citicoline, Creatine, and Omega-3 Arm

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Age 40-60 years

You may not qualify if:

• Significant medical condition
• History of co-morbid psychiatric disorders
• Current Axis I or II diagnosis
• Past participation in a pharmacotherapeutic trial
• Head injury with LOC\>5 minutes
• Use of psychotropic medication
• History of fish allergies
• Medical condition associated with clinically significant decreases in coagulability
• Use of anticoagulant medication

Sponsors & Collaborators

• Deborah Yurgelun-Todd: lead

Study Sites (1)

The Brain Institute

Salt Lake City, Utah, 84108, United States

Location

Related Links

• Click here for more information about Citicoline
• Click here for more information about Omega-3 Fatty Acids

MeSH Terms

Interventions

Cytidine Diphosphate Choline; Fatty Acids, Omega-3; Creatine

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Guanidines; Amidines; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Deborah Yurgelun-Todd, Ph.D.
• Organization: University of Utah, Diagnostic Neuroimaging Lab

Deborah.Yurgelun-Todd@hsc.utah.edu

801-587-1538

Study Officials

• Deborah Yurgelun-Todd, PhD

  The Brain Institute, University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: January 2, 2012
• Study Start: February 1, 2012
• Primary Completion: October 30, 2018
• Study Completion: November 1, 2019
• Last Updated: April 22, 2021
• Results First Posted: April 22, 2021

Record last verified: 2021-04

Locations

US (1)