search
Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Green tea
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Antioxidant oxidant balance, Activation of Antioxidant Response Element

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Our Lady of Maryknoll HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 15, 2011
Last Updated
March 15, 2011
Sponsor
The Hong Kong Polytechnic University
Collaborators
Our Lady of Maryknoll Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01315977
Brief Title
Dietary Antioxidants, Redox Tone and Health Promotion: an Orthomolecular Study of Interactions
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 Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Our Lady of Maryknoll Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, Antioxidant oxidant balance, Activation of Antioxidant Response Element

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Green tea
Intervention Description
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
Primary Outcome Measure Information:
Title
Activation of Antioxidant Response Element After Consumption of Green Tea
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris BENZIE, DPhil
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Study Chair
Facility Information:
Facility Name
Our Lady of Maryknoll Hospital
City
Kowloon
State/Province
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siu Wai CHOI, PhD
Phone
+852 3400 8598
Email
htswchoi@inet.polyu.edu.hk

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs