NCT01174576

Brief Summary

The purpose of the study is to investigate whether caffeinated and decaffeinated coffee consumption has acute effects on subjective appetite feelings, energy intake and biochemical markers related to appetite, inflammation and glucose metabolism compared to water consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

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

February 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2010

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

September 30, 2013

Completed
Last Updated

September 30, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

July 26, 2010

Results QC Date

September 4, 2012

Last Update Submit

July 26, 2013

Conditions

Keywords

coffeeappetiteenergy intakeinflammationcortisolglucoserandomized controlled trial

Outcome Measures

Primary Outcomes (11)

  • Ghrelin Total Area Under the Curve

    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

    15 min before ingestion to 3 hr post ingestion

  • Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve

    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

    15 min before ingestion to 3 hr post ingestion

  • Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve

    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

    15 min before ingestion to 3 hr post ingestion

  • Adiponectin Total Area Under the Curve

    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

    15 min before ingestion to 3 h post ingestion

  • Inteleukin-6 Total Area Under the Curve

    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

    15 min before ingestion to 3 hr post ingestion

  • Interleukin-18 Total Area Under the Curve

    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

    15 min before ingestion to 3 hr post ingestion

  • Glucose Total Area Under the Curve

    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

    15 min before ingestion to 3 hr post ingestion

  • Insulin Total Area Under the Curve

    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

    15 min before ingestion to 3 hr post ingestion

  • Cortisol Total Area Under the Curve

    Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.

    15 min before ingestion to 3 hr post ingestion

  • Energy ad Libitum Meal

    The energy of first meal 3 hr after ingestion

    3 hr post ingestion

  • Total Energy Intake

    the energy consumed at breakfast, ad libitum meal and rest of the experimental day

    1 d

Secondary Outcomes (1)

  • Serum Antioxidant Capacity Total Area Under the Curve

    15 min before ingestion to 21/2 hr post ingestion

Study Arms (3)

caffeinated coffee

EXPERIMENTAL

200 mL caffeinated coffee with 3 mg caffeine per kg body weight

Other: caffeinated and decaffeinated coffee

decaffeinated coffee

EXPERIMENTAL

200 mL decaffeinated coffee, same amount as caffeinated coffee

Other: caffeinated and decaffeinated coffee

Water

EXPERIMENTAL

200 mL, control intervention

Other: caffeinated and decaffeinated coffee

Interventions

3 treatments on separate days, i.e. a standard breakfast with oral ingestion of 200 ml of either caffeinated coffee (3mg caffeine/kg body weight), decaffeinated coffee or water

Watercaffeinated coffeedecaffeinated coffee

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • non-obese

You may not qualify if:

  • smokers
  • restrained eaters (as this was evaluated using the Dutch Eating Behaviour Questionnaire and a total score \> 2.5)
  • those who reported slimming or any other dietary regime
  • abstainers from caffeine sources
  • athletes during competition period
  • participants with a known diagnosis of either hypertension, diabetes, impaired glucose tolerance or a fasting blood glucose concentration above 125 mg/dl
  • subjects on medication for hypertension or on medication known to alter glucose metabolism
  • subjects who were on medication that may have an impact on appetite and sensory functioning or who reported a metabolic or endocrine disease, gastrointestinal disorders, or a history of medical or surgical events that may have affected the study outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metabolic Unit of the Department of Nutrition and Dietetics, Harokopio University

Athens, 17671, Greece

Location

Related Publications (1)

  • Gavrieli A, Yannakoulia M, Fragopoulou E, Margaritopoulos D, Chamberland JP, Kaisari P, Kavouras SA, Mantzoros CS. Caffeinated coffee does not acutely affect energy intake, appetite, or inflammation but prevents serum cortisol concentrations from falling in healthy men. J Nutr. 2011 Apr 1;141(4):703-7. doi: 10.3945/jn.110.137323. Epub 2011 Feb 23.

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

the results cannot be generalized to other population groups, as participants were selected according to specific criteria.

Results Point of Contact

Title
Dr. Mary Yannakoulia
Organization
Harokopio University

Study Officials

  • Mary Yannakoulia, PhD

    Harokopio University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 26, 2010

First Posted

August 3, 2010

Study Start

February 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

September 30, 2013

Results First Posted

September 30, 2013

Record last verified: 2013-07

Locations