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

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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
Sponsor:
Collaborator:
Our Lady of Maryknoll Hospital
Information provided by:
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.


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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : February 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
U.S. FDA Resources


Intervention Details:
    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


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315977


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   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Our Lady of Maryknoll Hospital
Investigators
Study Chair: Iris BENZIE, DPhil The Hong Kong Polytechnic University

Responsible Party: Dr Siu-Wai CHOI, Postdoctoral Fellow
ClinicalTrials.gov Identifier: NCT01315977     History of Changes
Other Study ID Numbers: HKCTR-1243
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: February 2011

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
Protective Agents
Physiological Effects of Drugs