The Dual Impact of Homocysteine and Cholesterol on Cognitive Functions

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.

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Key information

Conditions

Hypercholesterolemia Amino Acid Metabolism, Inborn Errors Avitaminosis Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Dementia Dyslipidemias Genetic Diseases, Inborn Hyperhomocysteinemia Hyperlipidemias Lipid Metabolism Disorders Malabsorption Syndromes Malnutrition Mental Disorders Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Neurocognitive Disorders Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B Deficiency

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Michael W Ameen

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests.

Diagnostic Test

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Aug 15, 2018
Registry last updated: Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed