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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by The Hong Kong Polytechnic University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Our Lady of Maryknoll Hospital
Information provided by:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01315977
First received: March 15, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • 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)
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
  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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 August 19, 2014