The Dual Impact of Homocysteine and Cholesterol on Cognitive Functions

August 15, 2018 updated by: MWAmeen, Assiut University
The study evaluates if the relationship between total serum cholesterol is dependent on the total serum homocysteine. Fasting blood samples will taken from participants and two batteries of cognitive scales will be used to asses any cognitive decline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The relationship between total serum cholesterol (TC) levels and cognition remains wily.

Some studies suggested that high TC level in old peoples is associated with a decreased risk of dementia.

Other studies have indicated that hypercholesterolemia may be a risk factor for cognitive decline and Alzheimer's disease (AD).

But a recent study published in 2014 by Cheng and colleagues, showed that, an inverse U-shaped relationship between total cholesterol level and cognitive score was found only in participants with normal homocysteine levels. Indicating that both low and high total serum cholesterol were associated with lower cognitive scores, ended to the relationship between cholesterol levels and cognitive function depends upon homocysteine levels, suggesting an interactive role between cholesterol and homocysteine on cognitive function in the elderly peoples.

The effect of high serum homocysteine (HHcy) levels on cognition was overwhelming regardless of the serum cholesterol levels but in peoples with normal homocysteine levels, both low and high cholesterol levels may be detrimental to cognitive health.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Michael W Ameen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study included 41 participants, randomly selected from out-patient neurology and psychiatry clinics , Assiut University Hospital.

Description

Inclusion Criteria:

  • Fifty hundred participants
  • Participants are of both genders
  • Aged 55 years old and over.

Exclusion Criteria:

  • Patient with dementia.
  • Renal and hepatic impairment.
  • Parkinson's disease.
  • Cerebrovascular stroke.
  • Patient with chronic medical problems.
  • Patients on statins.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Apparently normal participants
Participants are not complaining from any cognitive decline are subjected to cognitive and cholesterol and homocysteine levels assessment.
Diagnostic test: Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests.

all participant are subjected to cognitive assessment by psychometric tests by using the arabic version of Mini Mental State Exam (MMSE) and Memory Assessment Scale (MAS).

Blood samples were collected in the morning using 10 mL yellow top (plain) Vacutainer tubes.

Lipid profile (triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL)) were measured by Assiut university labs using Cholesterol Kits and analyzed by COBAS Integra analyzer.

Total cholesterol levels were calculated using the sum of the LDL and HDL plus one-fifth of triglyceride levels.

Samples of serum homocysteine are collected, centrifuged to separate plasma within 30 minutes after venipuncture and stored in specialized container in the Department of Clinical Pathology at (-20◦C) temperature.

Total homocysteine was measured by ELISA technique, Sinogen kits (Research Use Only) and Statfax-2100 microplate analyzer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlations between serum total cholesterol and homocysteine levels and cognitive functions
Time Frame: 1 hour

Blood samples were collected after an overnight fast by using 10 mL plain tubes.

Lipid profile was measured by using Cholesterol Kits and analyzed by COBAS Integra analyzer.

Total cholesterol levels were measured using the sum of the LDL and HDL plus one-fifth of triglyceride levels.

Samples of serum homocysteine (Hcy) are stored in specialized container at (-20◦C) temperature.

Total Hcy was measured by ELISA technique, Sinogen kits and Statfax-2100 micro-plate analyzer.

Cognitive functions were measured by using the Arabic version of: the 30 points Mini Mental State Exam (MMSE) and the Memory Assessment Scale (MAS) which consists of 12 subtests and the degree of 100 points.

The mean of total MAS plus MMSE degrees is used (e.g., (100+30)/2=65 Points which is the maximum score).

High, normal and low cholesterol level is compared to the mean of cognitive score only in participants with normal homocysteine levels (below 14 umol/l), higher levels of Hcy is excluded.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Nageh F El Gamal, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cholesterol and cognition

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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