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

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

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

Study Overview

• Status: Unknown
• Conditions: Atherosclerosis
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • Applied Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Young male students studying at Applied Science Private University (ASU) in Amman were approached for study participation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NW/MCC; Normal body mass index (BMI) / with moderate coffee consumption	Behavioral: Normal BMI and moderate coffee consumption; Normal BMI and moderate coffee consumption
NW/HCC; Normal body mass index (BMI) / with heavy coffee consumption	Behavioral: Normal BMI and heavy coffee consumption; Normal BMI and heavy coffee consumption
OW/MCC; Overweight / with moderate coffee consumption	Behavioral: overweight and moderate coffee consumption; overweight and moderate coffee consumption
OW/HCC; Overweight / with heavy coffee consumption	Behavioral: overweight and heavy coffee consumption; overweight and heavy coffee consumption

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Applied Science Private University
• Investigators: Principal Investigator: Mahmoud S Abu-samak, PhD, Applied Sciences Private University

Publications and helpful links

General Publications

• 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):480-4. doi: 10.1093/ajcn/71.2.480.
• Ma Y, Peng D, Liu C, Huang C, Luo J. Serum high concentrations of homocysteine and low levels of folic acid and vitamin B12 are significantly correlated with the categories of coronary artery diseases. BMC Cardiovasc Disord. 2017 Jan 21;17(1):37. doi: 10.1186/s12872-017-0475-8.
• Hasoun LZ, Khader HA, Abu-Taha MI, Mohammad BA, Abu-Samak MS. A Cross-Sectional Study on the Combined Effect of Body Weight and Coffee Consumption on Serum Levels of Leptin, Vitamin B12, and Folic Acid in Healthy Young Adult Males. J Multidiscip Healthc. 2021 Mar 15;14:639-650. doi: 10.2147/JMDH.S290990. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2020
• Primary Completion (Anticipated): September 26, 2020
• Study Completion (Anticipated): October 26, 2020

Study Registration Dates

• First Submitted: July 19, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Vitamin B12; Folic acid; BMI; Leptin; Coffee
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: 2020-PHA-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All IPD that underline results in a publication.
• IPD Sharing Time Frame: When summary data are published
• IPD Sharing Access Criteria: Open access
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No