Dietary Antioxidants, Redox Tone and Health Promotion: an Orthomolecular Study of Interactions
Orthomolecular Mechanisms of Health Effects of Antioxidant Rich Diets, With Focus on Green Tea (Camellia Sinensis), DNA Protection and Key Biochemical Products/Effects of the Antioxidant Response Element
1 other identifier
interventional
60
1 country
1
Brief Summary
Aging is associated with increased risk of various diseases, and much attention is given to the use of natural products (like herbs) and 'functional food', such as teas, for healthy aging. The body is continuously exposed to potentially damaging agents (known as free radicals). The imbalance between the amount of free radicals and that of antioxidants in the body is known as oxidative stress. It is known that Type 2 DM is a state of increased oxidative stress, which is thought to lead to many long term complications of Type 2 DM, such as heart disease, vision problems and kidney failure. Antioxidant therapy, including increased consumption of antioxidant rich foods and beverages such as green tea, has been suggested as possibly beneficial in lowering the risk of these complications. The purpose of this study is to examine the effects of regular intake of green tea on indices of oxidative stress and antioxidant defense within cells, plasma and urine so as to investigate if regular intake of green tea can be recommended for health promotion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 type-2-diabetes-mellitus
Started Feb 2011
Typical duration for phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 15, 2011
CompletedFirst Posted
Study publicly available on registry
March 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMarch 16, 2011
February 1, 2011
1 year
March 15, 2011
March 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Activation of Antioxidant Response Element After Consumption of Green Tea
Biomarkers of antioxidant and oxidant balance, antioxidant response element activation (through gene and protein expression studies and plasma biomarkers) will be determined pre and post consumption of green tea
12 weeks
Interventions
Each subject will take either green tea (2%w/v), or water, twice a day for twelve weeks, then wash out for twelve weeks and swap onto the other treatment (either green tea of water) for another twelve weeks in addition to their normal food and beverage intake
Eligibility Criteria
You may qualify if:
- Type 2 DM subjects
- Genotyped for polymorphism in the heme-oxygenase gene promoter region to be homozygous for long (\> 26) or short (\< 24) GT repeats
You may not qualify if:
- smokers
- have suffered DM related complication
- already taking antioxidant or herbal supplements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Our Lady of Maryknoll Hospital
Kowloon, Hong Kong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Iris BENZIE, DPhil
The Hong Kong Polytechnic University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 15, 2011
First Posted
March 16, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2012
Study Completion
April 1, 2012
Last Updated
March 16, 2011
Record last verified: 2011-02