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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04488731
• Other study ID #: 2020-PHA-19
• Status: Enrolling by invitation
• Start date: July 26, 2020
• Est. completion date: October 26, 2020

Study information

• Verified date: July 2020
• Source: Applied Science Private University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: October 26, 2020
• Est. primary completion date: September 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Behavioral:
• Normal BMI and moderate coffee consumption
Normal BMI and moderate coffee consumption
• Normal BMI and heavy coffee consumption
Normal BMI and heavy coffee consumption
• overweight and moderate coffee consumption
overweight and moderate coffee consumption
• overweight and heavy coffee consumption
overweight and heavy coffee consumption

Locations

Country	Name	City	State
Jordan	Applied Science University	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Applied Science Private University

Country where clinical trial is conducted

Jordan, 

References & Publications (2)

Grubben MJ, Boers GH, Blom HJ, Broekhuizen R, de Jong R, van Rijt L, de Ruijter E, Swinkels DW, Nagengast FM, Katan MB. Unfiltered coffee increases plasma homocysteine concentrations in healthy volunteers: a randomized trial. Am J Clin Nutr. 2000 Feb;71(2 — View Citation

Ma Y, Peng D, Liu C, Huang C, Luo J. Serum high concentrations of homocysteine and low levels of folic acid and vitamin B(12) are significantly correlated with the categories of coronary artery diseases. BMC Cardiovasc Disord. 2017 Jan 21;17(1):37. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	leptin	Plasma Concentration of leptin in ng /ml	Baseline
Primary	folic acid	Plasma Concentration of folic acid in ng /ml	Baseline
Primary	Vitamin B12	Plasma Concentration of Vitamin B12 in pg /ml	Baseline
Secondary	fasting blood glucose	Plasma Concentration of glucose mg/dL	Baseline
Secondary	lipid profile	Plasma Concentration of LDL, HDL in mg/dl	Baseline