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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01315977
• Other study ID #: HKCTR-1243
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 15, 2011
• Last updated: March 15, 2011
• Start date: February 2011
• Est. completion date: April 2012

Study information

• Verified date: February 2011
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Kowloon West Cluster- Clinical Research Ethics Committee (KWC-CREC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
China	Our Lady of Maryknoll Hospital	Kowloon	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Our Lady of Maryknoll Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No