Exploratory BehaviorNCT01615289
Neural Effects of Green Tea Extract on Dorsolateral Prefrontal Cortex
A study testing Single intragastric instillation of 250 ml green tea extract and Single intragastric instillation of 500 ml green tea extract in people with Exploratory Behavior, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Green tea is being recognized as a beverage with potential benefits for human health and on cognitive function. In vitro and in vivo studies provide preliminary evidence that green tea intake may play a positive role in improving effects on cognitive functions. 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
- Exploratory Behavior
- What is being tested?
- Single intragastric instillation of 250 ml green tea extract and Single intragastric instillation of 500 ml green tea extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2010to Jan 2012
- 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
- right-handed healthy males, no drugs, non-smoking
Who cannot join
- drug abuse, smoker, left-handed
Trial locations and contacts
1 site in 1 country.
About this study
Green tea is being recognized as a beverage with potential benefits for human health and on cognitive function. In vitro and in vivo studies provide preliminary evidence that green tea intake may play a positive role in improving effects on cognitive functions. The investigators aim to examine the neural effects of green tea extract on brain activation in humans.
Read the detailed description
As functional neuroimaging provides a means of examining how green tea extract acts on the brain, we used functional magnetic resonance imaging (fMRI) to study healthy volunteers while they performed a working memory task following intra-gastric administration of either 250 ml or 500 ml Rivella green® (RG), a milk whey based green tea extract containing soft drink, or Rivella blue® (RB), a milk whey based soft drink without green tea extract as sham condition in a double-blind, controlled design. Based on the literature on pharmacological and behavioural effects of green tea, we hypothesized - a priori - that green tea extract would subtly modulate the engagement of the dorsolateral prefrontal cortex (DLPFC), a brain region critically involved in many cognitive functions such as working memory processing.
A double-blind, controlled, within-subject study with counterbalanced order of substance administration using an established protocol (6-8) was conducted over 4 sessions (250 ml or 500 ml Rivella green® (including green tea extract; RG), 250 or 500 ml Rivella blue® (RB). Each participant was scanned four times with a one-week interval between scans. The order of substance administration across sessions was counterbalanced across subjects, such that equal numbers followed each substance sequence.
- Conditions
- Exploratory Behavior
- Being tested
- Single intragastric instillation of 250 ml green tea extract, Single intragastric instillation of 500 ml green tea extract, Single intragastric instillation of 250 ml control solution, Single intragastric instillation of 500 ml control solution
- Medical subject headings
- Exploratory Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single intragastric instillation of 250 ml green tea extractDietary supplement
Intragastric instillation by feeding tube
Single intragastric instillation of 500 ml green tea extractDietary supplement
Intragastric instillation by feeding tube
Single intragastric instillation of 250 ml control solutionDietary supplement
Intragastric instillation by feeding tube
Single intragastric instillation of 500 ml control solutionDietary supplement
Intragastric instillation by feeding tube
| Study group | Role | What they receive |
|---|---|---|
| Green tea extract, 250 ml | Active comparator | Single intragastric instillation of 250 ml green tea extract Receives: Dietary Supplement: Single intragastric instillation of 250 ml green tea extract |
| Green tea extract, 500 ml | Active comparator | Intragastric instillation of 500 ml green tea extract solution Receives: Dietary Supplement: Single intragastric instillation of 500 ml green tea extract |
| Control solution, 250 ml | Placebo comparator | Intragastric instillation of 250 ml control solution Receives: Dietary Supplement: Single intragastric instillation of 250 ml control solution |
| Control solution, 500 ml | Placebo comparator | Single intragastric instillation of 500 ml control solution Receives: Dietary Supplement: Single intragastric instillation of 500 ml control solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging (fMRI) in healthy volunteers while they performed a working memory task
Whole brain analysis with a cluster-level threshold was followed by an a priori defined region of interest analysis of the dorsolateral prefrontal cortex including a cluster-level threshold and family-wise error adjustment for multiple comparisons.
Measured: 0 and 45 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exploratory BehaviorStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Beglinger, University Hospital, Basel, Switzerland
- Investigators
- Christoph Beglinger, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615289
- Sponsor's protocol ID
- EKBB 32/09
- Status last verified
- Jun 2012
- First submitted
- 5 Jun 2012
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Effects of Green Tea Extract on Dorsolateral Prefrontal Cortex
- ClinicalTrials.gov ID
- NCT01615289
- Acronym / sponsor ID
- EKBB 32/09
- Conditions
- Exploratory Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Jun 2012 (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.
Green tea is being recognized as a beverage with potential benefits for human health and on cognitive function. In vitro and in vivo studies provide preliminary evidence that green tea intake may play a positive role in improving effects on cognitive functions. The investigators aim to examine the neural effects of green tea extract on brain activation in humans.
Detailed description
As functional neuroimaging provides a means of examining how green tea extract acts on the brain, we used functional magnetic resonance imaging (fMRI) to study healthy volunteers while they performed a working memory task following intra-gastric administration of either 250 ml or 500 ml Rivella green® (RG), a milk whey based green tea extract containing soft drink, or Rivella blue® (RB), a milk whey based soft drink without green tea extract as sham condition in a double-blind, controlled design. Based on the literature on pharmacological and behavioural effects of green tea, we hypothesized - a priori - that green tea extract would subtly modulate the engagement of the dorsolateral prefrontal cortex (DLPFC), a brain region critically involved in many cognitive functions such as working memory processing.
A double-blind, controlled, within-subject study with counterbalanced order of substance administration using an established protocol (6-8) was conducted over 4 sessions (250 ml or 500 ml Rivella green® (including green tea extract; RG), 250 or 500 ml Rivella blue® (RB). Each participant was scanned four times with a one-week interval between scans. The order of substance administration across sessions was counterbalanced across subjects, such that equal numbers followed each substance sequence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Green tea extract, 250 ml | Active comparator | Dietary Supplement: Single intragastric instillation of 250 ml green tea extractSingle intragastric instillation of 250 ml green tea extract |
| Green tea extract, 500 ml | Active comparator | Dietary Supplement: Single intragastric instillation of 500 ml green tea extractIntragastric instillation of 500 ml green tea extract solution |
| Control solution, 250 ml | Placebo comparator | Dietary Supplement: Single intragastric instillation of 250 ml control solutionIntragastric instillation of 250 ml control solution |
| Control solution, 500 ml | Placebo comparator | Dietary Supplement: Single intragastric instillation of 500 ml control solutionSingle intragastric instillation of 500 ml control solution |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- right-handed healthy males, no drugs, non-smoking
Key exclusion criteria (1 listed)
- drug abuse, smoker, left-handed
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 |
|---|---|---|
| Single intragastric instillation of 250 ml green tea extractIntragastric instillation by feeding tube | Dietary supplement | Green tea extract, 250 ml |
| Single intragastric instillation of 500 ml green tea extractIntragastric instillation by feeding tube | Dietary supplement | Green tea extract, 500 ml |
| Single intragastric instillation of 250 ml control solutionIntragastric instillation by feeding tube | Dietary supplement | Control solution, 250 ml |
| Single intragastric instillation of 500 ml control solutionIntragastric instillation by feeding tube | Dietary supplement | Control solution, 500 ml |
Primary outcome
Functional magnetic resonance imaging (fMRI) in healthy volunteers while they performed a working memory task
Time frame: 0 and 45 min
Whole brain analysis with a cluster-level threshold was followed by an a priori defined region of interest analysis of the dorsolateral prefrontal cortex including a cluster-level threshold and family-wise error adjustment for multiple comparisons.
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 8 Jun 2012.
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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.
Christoph Beglinger, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single intragastric instillation of 250 ml green tea extract and Single intragastric instillation of 500 ml green tea extract in people with Exploratory Behavior, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 1 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 8 Jun 2012. 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 Switzerland. 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?
Functional magnetic resonance imaging (fMRI) in healthy volunteers while they performed a working memory task (time frame: 0 and 45 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 8 Jun 2012.