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

• Conditions: Atherosclerosis
• Interventions: 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

• Registration Number: NCT04488731
• Lead Sponsor: Applied Science Private University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-19
• Study First Submitted QC: 2020-07-23
• Study Start: 2020-07-26
• Study First Posted: 2020-07-28
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-14
• Primary Completion: 2020-09-26
• Study Completion: 2020-10-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NW/MCC	Normal BMI and moderate coffee consumption	Normal body mass index (BMI) / with moderate coffee consumption
NW/HCC	Normal BMI and heavy coffee consumption	Normal body mass index (BMI) / with heavy coffee consumption
OW/MCC	overweight and moderate coffee consumption	Overweight / with moderate coffee consumption
OW/HCC	overweight and heavy coffee consumption	Overweight / with heavy coffee consumption

Primary Outcome Measures

Name	Time	Method
leptin	Baseline	Plasma Concentration of leptin in ng /ml
folic acid	Baseline	Plasma Concentration of folic acid in ng /ml
Vitamin B12	Baseline	Plasma Concentration of Vitamin B12 in pg /ml

Secondary Outcome Measures

Name	Time	Method
fasting blood glucose	Baseline	Plasma Concentration of glucose mg/dL
lipid profile	Baseline	Plasma Concentration of LDL, HDL in mg/dl

Trial Locations

Locations (1)

Applied Science University; 🇯🇴 Amman, Jordan