Cognitive FunctionPhase 4NCT00981292
Effects of Epigallocatechin Gallate (EGCG) in Healthy, Young Adults
A Phase 4 study testing EGCG in people with Cognitive Function and Mood, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Epigallocatechin gallate (EGCG) is the most abundant catechin (sometimes referred to as tea flavonoids) in green tea extract. A review by Nagle et al (2006) identifies that a large amount of research indicates EGCG (amongst other catechins) is responsible for most of the potential health benefits associated with green… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Mood
- What is being tested?
- EGCG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Dec 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- aged 18-35
- either caffeine consumers (consume more than 150mg caffeine per day) or non-consumers (consume less than 44mg caffeine per day).
Who cannot join
- smoke or consume any tobacco products
- not proficient in English language
- pregnant (or seeking to become pregnant)
- taking recreational, over the counter/prescription medication (including the contraceptive pill), and/or dietary/herbal supplements
- have food allergies or sensitivities
- have history of/current head trauma, learning difficulties , ADHD, migraines or any gastric problems
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
Official title: Cerebral Blood Flow, Cerebro-electrical Activity and Behavioural Effects of Epigallocatechin Gallate (EGCG) Administration in Healthy, Young Adults
Epigallocatechin gallate (EGCG) is the most abundant catechin (sometimes referred to as tea flavonoids) in green tea extract. A review by Nagle et al (2006) identifies that a large amount of research indicates EGCG (amongst other catechins) is responsible for most of the potential health benefits associated with green tea. EGCG is brain permeable (Nakagawa \& Miyazawa, 1997), and it is considered to have neuroprotective and neurorescue effects including modulation of cell survival and cell cycle genes (Levites et al 2002).
Although there have been several human studies looking at the bioavailability of EGCG when administered in varying doses, there have been no studies that have specifically investigated the cognitive effects of this catechin in humans. Therefore, the purpose of this study is to assess the cerebral blood flow (using Near Infrared Spectroscopy), cerebro-electrical activity (EEG) and behavioural effects of EGCG. A randomised, double-blind, placebo-controlled, balanced crossover study will assess the effects of 135 mg and 270 mg pure EGCG in 24 healthy, young adults (18-35). Prior to the first active study day participants will attend a screening/training visit where relevant exclusion criteria will be assessed including any food sensitivities. They will also complete a caffeine consumption questionnaire in order to control for potential caffeine withdrawal effects as a result of restrictions of the study.
- Conditions
- Cognitive Function, Mood
- Being tested
- EGCG, Placebo
- Keywords
- Epigallocatechin Gallate, cerebral blood flow, Near Infrared spectroscopy, Electroencephalography, cognitive function, mood, cerebro-electrical activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGCGDietary supplement
Also called Teavigo
Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.
PlaceboDietary supplement
Pharmaceutical grade silica was utilized as placebo
| Study group | Role | What they receive |
|---|---|---|
| 135mg EGCG | Active comparator | Not described Receives: Dietary Supplement: EGCG; Dietary Supplement: Placebo |
| 270mg EGCG | Active comparator | Not described Receives: Dietary Supplement: EGCG; Dietary Supplement: Placebo |
| 0mg EGCG | Placebo comparator | Not described Receives: Dietary Supplement: EGCG; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation of Levels of Total Haemoglobin
This measure assessed changes in levels of total haemoglobin during the 42 minute post- dose task period. Levels are in μmol/L and represent change from baseline levels.
Measured: 42 minutes
Secondary outcomes (2)
Number of Participants With Significant Modulation of Cognitive Performance
The cognitive performance of participants was assessed via a range of computerised, mentally demanding, executive function tasks: Serial 3s and 7s subtractions, oddball reaction time task, rapid visual information processing, stroop and simple reaction time.These tasks were completed at baseline and then again 45 minutes after treatment administration. Significant modulation was determined if participants' post dose scores were significantly higher than baseline.
Measured: 42 minutes
Number of Participants With Significant Modulation of Mood.
Mood was assessed via computerised visual analogue scales at baseline and post- dose time points. Mood scores were calculated as change from baseline. And significant modulation was determined if baseline scores were significantly different to post dose.
Measured: 42 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal Haskell, Northumbria University
- Investigators
- Crystal Haskell, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981292
- Sponsor's protocol ID
- 24Z1
- Status last verified
- Mar 2012
- First submitted
- 21 Sep 2009
- Last updated
- 13 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Blood Flow, Cerebro-electrical Activity and Behavioural Effects of Epigallocatechin Gallate (EGCG) Administration in Healthy, Young Adults
- ClinicalTrials.gov ID
- NCT00981292
- Acronym / sponsor ID
- 24Z1
- Conditions
- Cognitive Function, Mood
- Keywords
- Epigallocatechin Gallate, cerebral blood flow, Near Infrared spectroscopy, Electroencephalography, cognitive function, mood, cerebro-electrical activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 13 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epigallocatechin gallate (EGCG) is the most abundant catechin (sometimes referred to as tea flavonoids) in green tea extract. A review by Nagle et al (2006) identifies that a large amount of research indicates EGCG (amongst other catechins) is responsible for most of the potential health benefits associated with green tea. EGCG is brain permeable (Nakagawa \& Miyazawa, 1997), and it is considered to have neuroprotective and neurorescue effects including modulation of cell survival and cell cycle genes (Levites et al 2002).
Although there have been several human studies looking at the bioavailability of EGCG when administered in varying doses, there have been no studies that have specifically investigated the cognitive effects of this catechin in humans. Therefore, the purpose of this study is to assess the cerebral blood flow (using Near Infrared Spectroscopy), cerebro-electrical activity (EEG) and behavioural effects of EGCG. A randomised, double-blind, placebo-controlled, balanced crossover study will assess the effects of 135 mg and 270 mg pure EGCG in 24 healthy, young adults (18-35). Prior to the first active study day participants will attend a screening/training visit where relevant exclusion criteria will be assessed including any food sensitivities. They will also complete a caffeine consumption questionnaire in order to control for potential caffeine withdrawal effects as a result of restrictions of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 135mg EGCG | Active comparator | Dietary Supplement: EGCG, Dietary Supplement: Placebo |
| 270mg EGCG | Active comparator | Dietary Supplement: EGCG, Dietary Supplement: Placebo |
| 0mg EGCG | Placebo comparator | Dietary Supplement: EGCG, Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- aged 18-35
- either caffeine consumers (consume more than 150mg caffeine per day) or non-consumers (consume less than 44mg caffeine per day).
Key exclusion criteria (6 listed)
- smoke or consume any tobacco products
- not proficient in English language
- pregnant (or seeking to become pregnant)
- taking recreational, over the counter/prescription medication (including the contraceptive pill), and/or dietary/herbal supplements
- have food allergies or sensitivities
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 |
|---|---|---|
| EGCGAlso: TeavigoAcute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days. | Dietary supplement | 0mg EGCG, 135mg EGCG, 270mg EGCG |
| PlaceboPharmaceutical grade silica was utilized as placebo | Dietary supplement | 0mg EGCG, 135mg EGCG, 270mg EGCG |
Primary outcome
Modulation of Levels of Total Haemoglobin
Time frame: 42 minutes
This measure assessed changes in levels of total haemoglobin during the 42 minute post- dose task period. Levels are in μmol/L and represent change from baseline levels.
2 secondary outcomes
Number of Participants With Significant Modulation of Cognitive Performance
Time frame: 42 minutes
Number of Participants With Significant Modulation of Mood.
Time frame: 42 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Crystal Haskell principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EGCG in people with Cognitive Function and Mood, run by Northumbria University at 1 site in United Kingdom.
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 3 inclusion and 6 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 13 Apr 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 United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Modulation of Levels of Total Haemoglobin (time frame: 42 minutes). 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 13 Apr 2012.