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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01815203
Other study ID # PH2013a
Secondary ID
Status Completed
Phase N/A
First received March 18, 2013
Last updated September 23, 2013
Start date March 2013
Est. completion date August 2013

Study information

Verified date September 2013
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.


Description:

In a blinded, randomized cross-over design, participants will receive either a capsule with caffeine or placebo at two separate occasions whereupon study tasks will be performed.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date August 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Only males

- 18 = 35 years

- Healthy (self rated)

- Used to drink caffeine

- Used to eat breakfast regularly (= 5 times a week).

- Non-smokers

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Caffeine
Administration of one gelatin capsule containing 200-300 mg of caffeine with subsequent cognitive tasks and food test.
Placebo
Administration of placebo with subsequent cognitive tasks and food test.

Locations

Country Name City State
Sweden Uppsala University Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Blood sample Blood glucose assessment in order to confirm fasted condition prior to study experiments. 5 min (1 sample) No
Primary Inhibition control Measurement inhibition control via a computer test (NoGo-Go task. 20 min No
Secondary Food test Measure of participants food intake. 20 min No
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