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Completed

NCT Number: NCT01594086

Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction

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.

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Key information

Age range

50 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

White Cross Nursing Home

Higashimurayama, Tokyo, 189-0021, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

green tea powder

Dietary Supplement

Consuming 2 g/day of green tea powder in three times divided for 3 months

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in serum lipid levels

    Time frame: between baseline and 3 months after

    Changes in serum lipid levels before and after the intervention

  2. Changes in serum folic acid levels

    Time frame: between baseline and 3 months after

    Changes in serum folic acid levels before and after the intervention

  3. Changes in mini mental state examination (MMSE) scores

    Time frame: between baseline and 3 months after

    Changes in mini mental state examination (MMSE) scores before and after the intervention

Sponsors and collaborators

Lead sponsor

University of Shizuoka

Other

Registry information

Official study title

Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction in Elderly: An Exploratory Clinical Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 8, 2012
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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