NCT04488731

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

July 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2020

Completed
Last Updated

August 14, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

July 19, 2020

Last Update Submit

August 13, 2020

Conditions

Atherosclerosis

Keywords

CoffeeBMILeptinFolic acidVitamin B12

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • fasting blood glucose

    Baseline

  • lipid profile

    Baseline

Study Arms (4)

NW/MCC

Normal body mass index (BMI) / with moderate coffee consumption

Behavioral: Normal BMI and moderate coffee consumption

NW/HCC

Normal body mass index (BMI) / with heavy coffee consumption

Behavioral: Normal BMI and heavy coffee consumption

OW/MCC

Overweight / with moderate coffee consumption

Behavioral: overweight and moderate coffee consumption

OW/HCC

Overweight / with heavy coffee consumption

Behavioral: overweight and heavy coffee consumption

Interventions

Normal BMI and moderate coffee consumptionBEHAVIORAL

Normal BMI and moderate coffee consumption

NW/MCC
Normal BMI and heavy coffee consumptionBEHAVIORAL

Normal BMI and heavy coffee consumption

NW/HCC
overweight and moderate coffee consumptionBEHAVIORAL

overweight and moderate coffee consumption

OW/MCC
overweight and heavy coffee consumptionBEHAVIORAL

overweight and heavy coffee consumption

OW/HCC

Eligibility Criteria

Age18 Years - 26 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly young males are considered
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • male,
  • ASU student,
  • do not have any acute or chronic medical conditions.

You may not qualify if:

  • students who used any medications for either an acute and/or a chronic condition during the past 3 months prior to the study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Science University

Amman, Jordan

Location

Related Publications (3)

  • 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.

    PMID: 10648261RESULT

  • 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.

    PMID: 28109191RESULT

  • 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.

    PMID: 33758508DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples will be retained

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mahmoud S Abu-samak, PhD

    Applied Sciences Private University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2020

First Posted

July 28, 2020

Study Start

July 26, 2020

Primary Completion

September 26, 2020

Study Completion

October 26, 2020

Last Updated

August 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

All IPD that underline results in a publication.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
When summary data are published
Access Criteria
Open access

Locations

JO(1)