- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01315977
Dietary Antioxidants, Redox Tone and Health Promotion: an Orthomolecular Study of Interactions
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Hong Kong
-
Kowloon, Hong Kong, China
- Recruiting
- Our Lady of Maryknoll Hospital
-
Contact:
- Siu Wai CHOI, PhD
- Phone Number: +852 3400 8598
- Email: htswchoi@inet.polyu.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Iris BENZIE, DPhil, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKCTR-1243
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
AstraZenecaRecruiting
Clinical Trials on Green tea
-
The University of Hong KongCompleted
-
Taipei City HospitalNational Yang Ming UniversityCompletedType 2 Diabetes | HyperlipidemiaTaiwan
-
Chiang Mai UniversityCompletedHyperuricemia | GoutThailand
-
University of ArizonaUnited States Department of DefenseCompletedLung Cancer Prevention
-
University of MinnesotaNational Cancer Institute (NCI)Completed
-
Charite University, Berlin, GermanyCompleted
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedProstate CancerUnited States
-
Texas Tech University Health Sciences CenterNational Center for Complementary and Integrative Health (NCCIH)Completed
-
University of AberdeenLipton Teas and InfusionsRecruitingThe Focus of the Study is Healthy VolunteersUnited Kingdom
-
Hayder Raad AbdulbaqiActive, not recruiting