NCT01495754

Brief Summary

The purpose of the study is to investigate whether different doses of caffeinated 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 in normal weight and overweight/obese participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable obesity

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

January 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2011

Completed
Last Updated

December 20, 2011

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

December 16, 2011

Last Update Submit

December 19, 2011

Conditions

ObesityInflammation

Keywords

coffeeoverweight/obeseappetiteenergy intakeinflammationglucose metabolismrandomized controlled trial

Outcome Measures

Primary Outcomes (38)

  • energy intake ad libitum

    180 min after breakfast/drink consumption

  • total energy intake

    One day

  • appetite feelings

    fasting (-15 min)

  • appetite feelings

    immediately after breakfast/drink consumption (0 min)

  • appetite feelings

    15 min after breakfast/drink consumption

  • appetite feelings

    30 min after breakfast/drink consumption

  • appetite feelings

    60 min after breakfast/drink consumption

  • appetite feelings

    90 min after breakfast/drink consumption

  • appetite feelings

    120 min after breakfast/drink consumption

  • appetite feelings

    150 min after breakfast/drink consumption

  • appetite feelings

    180 min after breakfast/drink consumption

  • appetite hormones

    fasting (-15 min)

  • appetite hormones

    immediately after breakfast/drink consumption (0 min)

  • appetite hormones

    15 min after breakfast/drink consumption

  • appetite hormones

    30 min after breakfast/drink consumption

  • appetite hormones

    60 min after breakfast/drink consumption

  • appetite hormones

    90 min after breakfast/drink consumption

  • appetite hormones

    120 min after breakfast/drink consumption

  • appetite hormones

    150 min after breakfast/drink consumption

  • appetite hormones

    180 min after breakfast/drink consumption

  • markers of inflammation

    fasting (-15 min)

  • markers of inflammation

    immediately after breakfast/drink consumption (0 min)

  • markers of inflammation

    15 min after breakfast/drink consumption

  • markers of inflammation

    30 min after breakfast/drink consumption

  • markers of inflammation

    60 min after breakfast/drink consumption

  • markers of inflammation

    90 min after breakfast/drink consumption

  • markers of inflammation

    120 min after breakfast/drink consumption

  • markers of inflammation

    150 min after breakfast/drink consumption

  • markers of inflammation

    180 min after breakfast/drink consumption

  • markers of glucose metabolism

    fasting (-15 min)

  • markers of glucose metabolism

    immediately after breakfast/drink consumption (0 min)

  • markers of glucose metabolism

    15 min after breakfast/drink consumption

  • markers of glucose metabolism

    30 min after breakfast/drink consumption

  • markers of glucose metabolism

    60 min after breakfast/drink consumption

  • markers of glucose metabolism

    90 min after breakfast/drink consumption

  • markers of glucose metabolism

    120 min after breakfast/drink consumption

  • markers of glucose metabolism

    150 min after breakfast/drink consumption

  • markers of glucose metabolism

    180 min after breakfast/drink consumption

Secondary Outcomes (6)

  • % carbohydrates ad libitum

    180 min after breakfast/drink consumption

  • % carbohydrates total day

    One day

  • % protein ad libitum

    180 min after breakfast/drink consumption

  • % protein total day

    One day

  • % fat

    180 min after breakfast/drink consumption

  • +1 more secondary outcomes

Study Arms (3)

coffee3

EXPERIMENTAL
Other: coffee

coffee6

EXPERIMENTAL
Other: coffee

water

PLACEBO COMPARATOR
Other: coffee

Interventions

coffeeOTHER

Comparison of different amounts of coffee

coffee3coffee6water

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • apparently healthy
  • habitual coffee drinkers (\>= 1cup of coffee/day)

You may not qualify if:

  • smokers
  • restrained eaters (as this was evaluated using the Dutch Eating Behaviour Questionnaire)
  • those who reported slimming or any other dietary regime
  • athletes
  • 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,
  • 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 (3)

  • 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.

    PMID: 21346100BACKGROUND

  • Perakakis N, Kokkinos A, Angelidi AM, Tsilingiris D, Gavrieli A, Yannakoulia M, Tentolouris N, Mantzoros CS. Circulating levels of five proglucagon-derived peptides in response to intravenous or oral glucose or lipids and to a mixed-meal in subjects with normal weight, overweight, and obesity. Clin Nutr. 2022 Sep;41(9):1969-1976. doi: 10.1016/j.clnu.2022.07.001. Epub 2022 Jul 19.

    PMID: 35961260DERIVED

  • Gavrieli A, Fragopoulou E, Mantzoros CS, Yannakoulia M. Gender and body mass index modify the effect of increasing amounts of caffeinated coffee on postprandial glucose and insulin concentrations; a randomized, controlled, clinical trial. Metabolism. 2013 Aug;62(8):1099-106. doi: 10.1016/j.metabol.2013.02.003. Epub 2013 Mar 15.

    PMID: 23498899DERIVED

MeSH Terms

Conditions

ObesityInflammationOverweight

Interventions

Coffee

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Mary Yannakoulia, PhD

    Harokopio University

    PRINCIPAL INVESTIGATOR

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
Assistant Professor

Study Record Dates

First Submitted

December 16, 2011

First Posted

December 20, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 20, 2011

Record last verified: 2011-12

Locations

GR(1)