NCT00950898

Brief Summary

The purpose of this study was to determine the acute effects of decaffeinated coffee, caffeinated coffee and caffeine on glucose metabolism in humans

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2006

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2009

Completed
Last Updated

August 3, 2009

Status Verified

July 1, 2009

Enrollment Period

7 months

First QC Date

July 31, 2009

Last Update Submit

July 31, 2009

Conditions

Type 2 Diabetes

Keywords

coffeecaffeineglucose metabolisminsulin sensitivitydiabetes

Outcome Measures

Primary Outcomes (1)

  • plasma glucose levels

    0, 10, 30, 60, 90, and 120 minutes.

Secondary Outcomes (1)

  • plasma insulin

    0, 10, 30, 60, 90, and 120 minutes

Interventions

decaffOTHER

2 mugs of decaffeinated coffee

caffcoffOTHER

2 mugs of caffeinated coffee

caffeineOTHER

2 mugs of hot water containing caffeine

placeboOTHER

2 mugs of hot water

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy young males
  • nonsmokers
  • moderate alcohol users

You may not qualify if:

  • not on any medications that could alter glucose metabolism
  • no history of blood disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooklyn College of the City University of New York

Brooklyn, New York, 11210, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceDiabetes Mellitus

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • James Greenberg, Ph.D.

    Brooklyn College of the City University of New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2009

First Posted

August 3, 2009

Study Start

November 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

August 3, 2009

Record last verified: 2009-07

Locations

US(1)