AtherosclerosisNCT04488731
The Effect of Coffee Consumption on the Serum Levels of Leptin, Folic Acid, and Vitamin B12
An observational study of Atherosclerosis, run by Applied Science Private University at 1 site in Jordan.
Trial summary
The effect of coffee and body weight during the last 3 months on the level of leptin, folic acid, and vitamin B12 Read more about this study
- Who is it for?
- Ages 18 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Normal BMI and moderate coffee consumption, Normal BMI and heavy coffee consumption and overweight and moderate coffee consumption
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteJordan
- Study dates
- 26 Jul 2020to 26 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Young male students studying at Applied Science Private University (ASU) in Amman were approached for study participation.
Who may be able to join
- male,
- ASU student,
- do not have any acute or chronic medical conditions.
Who cannot join
- students who used any medications for either an acute and/or a chronic condition during the past 3 months prior to the study entry.
Trial locations and contacts
1 site in 1 country.
About this study
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
The effect of coffee and body weight during the last 3 months on the level of leptin, folic acid, and vitamin B12
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- Normal BMI and moderate coffee consumption, Normal BMI and heavy coffee consumption, overweight and moderate coffee consumption, overweight and heavy coffee consumption
- Keywords
- Coffee, BMI, Leptin, Folic acid, Vitamin B12
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal BMI and moderate coffee consumptionBehavioural
Normal BMI and moderate coffee consumption
Normal BMI and heavy coffee consumptionBehavioural
Normal BMI and heavy coffee consumption
overweight and moderate coffee consumptionBehavioural
overweight and moderate coffee consumption
overweight and heavy coffee consumptionBehavioural
overweight and heavy coffee consumption
| Study group | Role | What they receive |
|---|---|---|
| NW/MCC | Normal body mass index (BMI) / with moderate coffee consumption Receives: Behavioral: Normal BMI and moderate coffee consumption | |
| NW/HCC | Normal body mass index (BMI) / with heavy coffee consumption Receives: Behavioral: Normal BMI and heavy coffee consumption | |
| OW/MCC | Overweight / with moderate coffee consumption Receives: Behavioral: overweight and moderate coffee consumption | |
| OW/HCC | Overweight / with heavy coffee consumption Receives: Behavioral: overweight and heavy coffee consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
leptin
Plasma Concentration of leptin in ng /ml
Measured: Baseline
folic acid
Plasma Concentration of folic acid in ng /ml
Measured: Baseline
Vitamin B12
Plasma Concentration of Vitamin B12 in pg /ml
Measured: Baseline
Secondary outcomes (2)
fasting blood glucose
Plasma Concentration of glucose mg/dL
Measured: Baseline
lipid profile
Plasma Concentration of LDL, HDL in mg/dl
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start26 Jul 2020
- Primary completion26 Sep 2020 (estimated)
- Study completion26 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Science Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud S Abu-samak, PhD, Principal investigator, Applied Sciences Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488731
- Sponsor's protocol ID
- 2020-PHA-19
- Status last verified
- Jul 2020
- First submitted
- 19 Jul 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underline results in a publication.
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.
PubMed 10648261Ma 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.
PubMed 28109191Hasoun 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.
PubMed 33758508
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04488731
- Acronym / sponsor ID
- 2020-PHA-19
- Conditions
- Atherosclerosis
- Keywords
- Coffee, BMI, Leptin, Folic acid, Vitamin B12
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- 26 Jul 2020 (actual)
- Primary completion
- 26 Sep 2020 (estimated)
- Study completion
- 26 Oct 2020 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NW/MCC | – | Behavioral: Normal BMI and moderate coffee consumptionNormal body mass index (BMI) / with moderate coffee consumption |
| NW/HCC | – | Behavioral: Normal BMI and heavy coffee consumptionNormal body mass index (BMI) / with heavy coffee consumption |
| OW/MCC | – | Behavioral: overweight and moderate coffee consumptionOverweight / with moderate coffee consumption |
| OW/HCC | – | Behavioral: overweight and heavy coffee consumptionOverweight / with heavy coffee consumption |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young male students studying at Applied Science Private University (ASU) in Amman were approached for study participation.
Key inclusion criteria (3 listed)
- male,
- ASU student,
- do not have any acute or chronic medical conditions.
Key exclusion criteria (1 listed)
- students who used any medications for either an acute and/or a chronic condition during the past 3 months prior to the study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal BMI and moderate coffee consumptionNormal BMI and moderate coffee consumption | Behavioural | NW/MCC |
| Normal BMI and heavy coffee consumptionNormal BMI and heavy coffee consumption | Behavioural | NW/HCC |
| overweight and moderate coffee consumptionoverweight and moderate coffee consumption | Behavioural | OW/MCC |
| overweight and heavy coffee consumptionoverweight and heavy coffee consumption | Behavioural | OW/HCC |
Primary outcome
leptin
Time frame: Baseline
Plasma Concentration of leptin in ng /ml
folic acid
Time frame: Baseline
Plasma Concentration of folic acid in ng /ml
Vitamin B12
Time frame: Baseline
Plasma Concentration of Vitamin B12 in pg /ml
2 secondary outcomes
fasting blood glucose
Time frame: Baseline
lipid profile
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Results publication: PubMed 10648261Grubben 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.
- Results publication: PubMed 28109191Ma 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.
- Derived from this study: PubMed 33758508Hasoun 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.
- Individual participant dataSharing planned: Yes. All IPD that underline results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud S Abu-samak, PhD principal investigator
Applied Sciences Private University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Applied Science Private University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
leptin (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04488731, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.