The Effect of Coffee Consumption on the Serum Levels of Leptin, Folic Acid, and Vitamin B12

Study Overview
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Brief Summary
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The effect of coffee and body weight during the last 3 months on the level of leptin, folic acid, and vitamin B12

Detailed Description
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Coffee consumption has been associated with several risk factors leading to cardiovascular diseases (CVDs), including hyperhomocysteinemia and hyperlipidemia. Frequent coffee consumption has beneficial effects in reducing the risk of diabetes mellitus (DM) type 2, obesity, liver disease, CVDs, some types of cancer, Parkinson's disease, and Alzheimer's disease. Controversies concerning coffee consumption benefits and risks in regards for CVDs were mentioned in many studies. Folic acid and vitamin B12 are necessary vitamins in homocysteine metabolism which is a risk factor for atherosclerosis. Leptin, is a hormone linked to obesity and it could be related to atherosclerosis. The combined effect of coffee consumption and body weight on the levels of leptin, folic aid, and vitamin B12 is not well studied. In our study, we will study the effect of coffee consumption in males with different body mass indices to see the effect of several important parameters such as leptin, Folic acid, and vitamin B12.

Official Title
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The Effect of Coffee Consumption and Body Weight on the Serum Levels of Leptin, Folic Acid, and Vitamin B12 in Young Males: A Cross-Sectional Study

Conditions
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Atherosclerosis

Intervention / Treatment
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* Behavioral: Normal BMI and moderate coffee consumption
* Behavioral: Normal BMI and heavy coffee consumption
* Behavioral: overweight and moderate coffee consumption
* Behavioral: overweight and heavy coffee consumption


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male, ASU student, do not have any acute or chronic medical conditions. Exclusion Criteria: students who used any medications for either an acute and/or a chronic condition during the past 3 months prior to the study entry.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NW/MCC<br>Normal body mass index (BMI) / with moderate coffee consumption | Behavioral: Normal BMI and moderate coffee consumption<br>* Normal BMI and moderate coffee consumption<br>|
| NW/HCC<br>Normal body mass index (BMI) / with heavy coffee consumption | Behavioral: Normal BMI and heavy coffee consumption<br>* Normal BMI and heavy coffee consumption<br>|
| OW/MCC<br>Overweight / with moderate coffee consumption | Behavioral: overweight and moderate coffee consumption<br>* overweight and moderate coffee consumption<br>|
| OW/HCC<br>Overweight / with heavy coffee consumption | Behavioral: overweight and heavy coffee consumption<br>* overweight and heavy coffee consumption<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leptin | Plasma Concentration of leptin in ng /ml | Baseline | 
| folic acid | Plasma Concentration of folic acid in ng /ml | Baseline | 
| Vitamin B12 | Plasma Concentration of Vitamin B12 in pg /ml | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting blood glucose | Plasma Concentration of glucose mg/dL | Baseline | 
| lipid profile | Plasma Concentration of LDL, HDL in mg/dl | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coffee, BMI, Leptin, Folic acid, Vitamin B12