Dietary Antioxidants, Redox Tone and Health Promotion: an Orthomolecular Study of Interactions
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Dietary Supplement: Green tea |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) 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 |
- Activation of Antioxidant Response Element After Consumption of Green Tea [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
-
Dietary Supplement: Green tea
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- smokers
- have suffered DM related complication
- already taking antioxidant or herbal supplements
Contacts and Locations| China, Hong Kong | |
| Our Lady of Maryknoll Hospital | Recruiting |
| Kowloon, Hong Kong, China | |
| Contact: Siu Wai CHOI, PhD +852 3400 8598 htswchoi@inet.polyu.edu.hk | |
| Study Chair: | Iris BENZIE, DPhil | The Hong Kong Polytechnic University |
More Information
No publications provided
| Responsible Party: | Dr Siu-Wai CHOI, Postdoctoral Fellow |
| ClinicalTrials.gov Identifier: | NCT01315977 History of Changes |
| Other Study ID Numbers: | HKCTR-1243 |
| Study First Received: | March 15, 2011 |
| Last Updated: | March 15, 2011 |
| Health Authority: | Hong Kong: Kowloon West Cluster- Clinical Research Ethics Committee (KWC-CREC) |
Keywords provided by The Hong Kong Polytechnic University:
|
Type 2 Diabetes Mellitus Antioxidant oxidant balance Activation of Antioxidant Response Element |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013