Dietary Antioxidants, Redox Tone and Health Promotion: an Orthomolecular Study of Interactions
|ClinicalTrials.gov Identifier: NCT01315977|
Recruitment Status : Unknown
Verified February 2011 by The Hong Kong Polytechnic University.
Recruitment status was: Recruiting
First Posted : March 16, 2011
Last Update Posted : March 16, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Dietary Supplement: Green tea||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||February 2012|
|Estimated Study Completion Date :||April 2012|
- Dietary Supplement: Green tea
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
- Activation of Antioxidant Response Element After Consumption of Green Tea [ Time Frame: 12 weeks ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315977
|China, Hong Kong|
|Our Lady of Maryknoll Hospital||Recruiting|
|Kowloon, Hong Kong, China|
|Contact: Siu Wai CHOI, PhD +852 3400 8598 email@example.com|
|Study Chair:||Iris BENZIE, DPhil||The Hong Kong Polytechnic University|