Dietary Antioxidants, Redox Tone and Health Promotion: an Orthomolecular Study of Interactions

Phase 1

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT01315977
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-02
• Study Start: 2011-02
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-15
• Last Update Submitted: 2011-03-15
• Study First Posted: 2011-03-16
• Last Update Posted: 2011-03-16
• Primary Completion: 2012-02
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Activation of Antioxidant Response Element After Consumption of Green Tea	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

Trial Locations

Locations (1)

Our Lady of Maryknoll Hospital; 🇨🇳 Kowloon, Hong Kong, China