NCT01815203

Brief Summary

With the abundance of energy-dense foods that are designed for ease of consumption in the current environment, it is of importance to better understand the factors that may undermine the control of energy intake at healthy levels. One of the factors that is potentially important in response inhibition is caffeine. The aim is to assess the direct effects of caffeine on response inhibition, using a No Go/Go-task. We will also assess whether the presentation of food cues, i.e. as words or as pictures, modulate response inhibition different in restrained vs. non-restrained eaters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 25, 2013

Status Verified

September 1, 2013

Enrollment Period

4 months

First QC Date

March 18, 2013

Last Update Submit

September 23, 2013

Conditions

Eating BehaviorObesity

Keywords

Caffeine effectsInhibitory control

Outcome Measures

Primary Outcomes (1)

  • Inhibition control

    Measurement inhibition control via a computer test (NoGo-Go task.

    20 min

Secondary Outcomes (1)

  • Food test

    20 min

Other Outcomes (1)

  • Blood sample

    5 min (1 sample)

Study Arms (2)

Caffeine

EXPERIMENTAL

Administration of one gelatin capsule containing 200-300 mg of caffeine with subsequent cognitive tasks and food test.

Drug: Caffeine

Placebo

PLACEBO COMPARATOR

Administration of placebo (one gelatin capsule containing starch) with subsequent cognitive tasks and food test.

Drug: Placebo

Interventions

CaffeineDRUG

Administration of one gelatin capsule containing 200-300 mg of caffeine with subsequent cognitive tasks and food test.

Caffeine
PlaceboDRUG

Administration of placebo with subsequent cognitive tasks and food test.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Only males
  • ≤ 35 years
  • Healthy (self rated)
  • Used to drink caffeine
  • Used to eat breakfast regularly (≥ 5 times a week).
  • Non-smokers

You may not qualify if:

  • BMI outside the range of 18,5 ≤ 25
  • hypersensitivity for the ingredients of the foods under study
  • being a vegan or vegetarian. Participants reported not using products that are artificially sweetened, nor sugar in coffee and/or tea
  • Presence of any chronically disease and/or treatment with medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, 75319, Sweden

Location

MeSH Terms

Conditions

Feeding BehaviorObesity

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pleunie Hogenkamp, PhD

    Uppsala University

    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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 20, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

September 25, 2013

Record last verified: 2013-09

Locations

SE(1)