Eating BehaviorNCT01815203
Caffein Consumption and Response Inhibition
A study testing Caffeine in people with Eating Behavior and Obesity, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Obesity
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only males
- 18 ≤ 35 years
- Healthy (self rated)
- Used to drink caffeine
- Used to eat breakfast regularly (≥ 5 times a week).
- Non-smokers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Caffeine Consumption Improve Response Inhibition to Food Cues?
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.
Read the detailed 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.
- Conditions
- Eating Behavior, Obesity
- Being tested
- Caffeine, Placebo
- Keywords
- Caffeine effects, Inhibitory control
- Medical subject headings
- Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Administration of one gelatin capsule containing 200-300 mg of caffeine with subsequent cognitive tasks and food test.
PlaceboDrug
Administration of placebo with subsequent cognitive tasks and food test.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | Administration of one gelatin capsule containing 200-300 mg of caffeine with subsequent cognitive tasks and food test. Receives: Drug: Caffeine |
| Placebo | Placebo comparator | Administration of placebo (one gelatin capsule containing starch) with subsequent cognitive tasks and food test. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition control
Measurement inhibition control via a computer test (NoGo-Go task.
Measured: 20 min
Secondary outcomes (1)
Food test
Measure of participants food intake.
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pleunie Hogenkamp, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815203
- Sponsor's protocol ID
- PH2013a
- Status last verified
- Sep 2013
- First submitted
- 18 Mar 2013
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Caffeine Consumption Improve Response Inhibition to Food Cues?
- ClinicalTrials.gov ID
- NCT01815203
- Acronym / sponsor ID
- PH2013a
- Conditions
- Eating Behavior, Obesity
- Keywords
- Caffeine effects, Inhibitory control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Drug: CaffeineAdministration of one gelatin capsule containing 200-300 mg of caffeine with subsequent cognitive tasks and food test. |
| Placebo | Placebo comparator | Drug: PlaceboAdministration of placebo (one gelatin capsule containing starch) with subsequent cognitive tasks and food test. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Only males
- 18 ≤ 35 years
- Healthy (self rated)
- Used to drink caffeine
- Used to eat breakfast regularly (≥ 5 times a week).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaffeineAdministration of one gelatin capsule containing 200-300 mg of caffeine with subsequent cognitive tasks and food test. | Drug | Caffeine |
| PlaceboAdministration of placebo with subsequent cognitive tasks and food test. | Drug | Placebo |
Primary outcome
Inhibition control
Time frame: 20 min
Measurement inhibition control via a computer test (NoGo-Go task.
1 secondary outcome
Food test
Time frame: 20 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pleunie Hogenkamp, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Eating Behavior and Obesity, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibition control (time frame: 20 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2013.