Clinical trial NCT04488731: The Effect of Coffee Consumption on the Serum Levels of Leptin, Folic Acid, and Vitamin B12
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Keywords: Coffee
BMI
Leptin
Folic acid
Vitamin B12
Lead sponsor: Applied Science Private University
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Young male students studying at Applied Science Private University (ASU) in Amman were approached for study participation.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: leptin
timeFrame: Baseline
measure: folic acid
timeFrame: Baseline
measure: Vitamin B12
timeFrame: Baseline
Secondary outcomes:
measure: fasting blood glucose
timeFrame: Baseline
measure: lipid profile
timeFrame: Baseline
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Applied Science University
Study officials:
affiliation: Applied Sciences Private University
name: Mahmoud S Abu-samak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.