Cognitive ImpairmentNCT01594086
Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction
A study testing green tea powder in people with Cognitive Impairment, run by University of Shizuoka at 1 site in Japan.
Trial summary
Green tea contains catechins and theanine as major ingredients and has been reported to have various beneficial influences on human health. It is reported that the drinking green tea is inversely associated with serum homocysteine level in elderly. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- green tea powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteJapan
- Study dates
- May 2012to Jul 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtained written informed consent before participation
- Possible to consume green tea powder
- Possessing cognitive dysfunction; MMSE score less than 30
- Possible not to take any supplement possessing anti-oxidizing effect; i.e., vitamin A, C, E, β-carotene
Who cannot join
- Possessing allergy to green tea
- Possessing severe cardiac, respiratory, renal, or hepatic dysfunction
- Possessing severe anemia
- Diagnosed as inadequate to participate in the study by doctor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction in Elderly: An Exploratory Clinical Study
Green tea contains catechins and theanine as major ingredients and has been reported to have various beneficial influences on human health. It is reported that the drinking green tea is inversely associated with serum homocysteine level in elderly. However the effect of green tea consumption on cognitive dysfunction is not clinically clarified. The purpose of this study is to investigate the effects of green tea consumption on homocysteine metabolism and cognitive dysfunction in elderly with impaired cognitive function.
Read the detailed description
Elderly people with impaired cognitive function go on increasing year by year with the coming aged society. Among them, the Alzheimer disease is a major cause of the illness, which is progressively worse, has no fundamental curable therapy, and induces the burdens of caregivers as well as the health insurance and national budget. Recently, homocysteine metabolism is reported to be related to atherosclerosis in aging, and draw attention as the etiology of cognitive dysfunction in elderly.
Green tea contains catechins and theanine as main ingredients. These components are reported to have anti-atherogenic action and effect on improving cognitive dysfunction. However, clinical evidence for homocysteine metabolism and cognitive dysfunction has not been clarified. Therefore, in this study, the investigators attempted to investigate the effects of green tea consumption on homocysteine metabolism and cognitive dysfunction in elderly with impaired cognitive function.
- Conditions
- Cognitive Impairment
- Being tested
- green tea powder
- Keywords
- green tea, aging, atherosclerosis, homocysteine, cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green tea powderDietary supplement
Consuming 2 g/day of green tea powder in three times divided for 3 months
| Study group | Role | What they receive |
|---|---|---|
| green tea powder | Experimental | Natural green tea powder Receives: Dietary Supplement: green tea powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the serum homocysteine levels
Changes in the serum homocysteine levels before and after the intervention
Measured: between baseline and 3 months after
Secondary outcomes (3)
Changes in serum lipid levels
Changes in serum lipid levels before and after the intervention
Measured: between baseline and 3 months after
Changes in serum folic acid levels
Changes in serum folic acid levels before and after the intervention
Measured: between baseline and 3 months after
Changes in mini mental state examination (MMSE) scores
Changes in mini mental state examination (MMSE) scores before and after the intervention
Measured: between baseline and 3 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Shizuoka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yamada, Hiroshi, Study chair, University of Shizuoka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594086
- Sponsor's protocol ID
- CT201201
- Other IDs
- 24220501
- Status last verified
- Jul 2013
- First submitted
- 1 May 2012
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction in Elderly: An Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT01594086
- Acronym / sponsor ID
- CT201201
- Conditions
- Cognitive Impairment
- Keywords
- green tea, aging, atherosclerosis, homocysteine, cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of ShizuokaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 May 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 contains catechins and theanine as major ingredients and has been reported to have various beneficial influences on human health. It is reported that the drinking green tea is inversely associated with serum homocysteine level in elderly. However the effect of green tea consumption on cognitive dysfunction is not clinically clarified. The purpose of this study is to investigate the effects of green tea consumption on homocysteine metabolism and cognitive dysfunction in elderly with impaired cognitive function.
Detailed description
Elderly people with impaired cognitive function go on increasing year by year with the coming aged society. Among them, the Alzheimer disease is a major cause of the illness, which is progressively worse, has no fundamental curable therapy, and induces the burdens of caregivers as well as the health insurance and national budget. Recently, homocysteine metabolism is reported to be related to atherosclerosis in aging, and draw attention as the etiology of cognitive dysfunction in elderly.
Green tea contains catechins and theanine as main ingredients. These components are reported to have anti-atherogenic action and effect on improving cognitive dysfunction. However, clinical evidence for homocysteine metabolism and cognitive dysfunction has not been clarified. Therefore, in this study, the investigators attempted to investigate the effects of green tea consumption on homocysteine metabolism and cognitive dysfunction in elderly with impaired cognitive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| green tea powder | Experimental | Dietary Supplement: green tea powderNatural green tea powder |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Obtained written informed consent before participation
- Possible to consume green tea powder
- Possessing cognitive dysfunction; MMSE score less than 30
- Possible not to take any supplement possessing anti-oxidizing effect; i.e., vitamin A, C, E, β-carotene
Key exclusion criteria (4 listed)
- Possessing allergy to green tea
- Possessing severe cardiac, respiratory, renal, or hepatic dysfunction
- Possessing severe anemia
- Diagnosed as inadequate to participate in the study by doctor
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 |
|---|---|---|
| green tea powderConsuming 2 g/day of green tea powder in three times divided for 3 months | Dietary supplement | green tea powder |
Primary outcome
Changes in the serum homocysteine levels
Time frame: between baseline and 3 months after
Changes in the serum homocysteine levels before and after the intervention
3 secondary outcomes
Changes in serum lipid levels
Time frame: between baseline and 3 months after
Changes in serum folic acid levels
Time frame: between baseline and 3 months after
Changes in mini mental state examination (MMSE) scores
Time frame: between baseline and 3 months after
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 16 Jul 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.
Yamada, Hiroshi study chair
University of Shizuoka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing green tea powder in people with Cognitive Impairment, run by University of Shizuoka at 1 site in Japan.
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 4 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 16 Jul 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 Japan. 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. 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?
Changes in the serum homocysteine levels (time frame: between baseline and 3 months after). 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 16 Jul 2013.