Green Tea Effect on Anthropometric, Oxidation and Inflammation Parameters in Physically Active vs. Sedentary Elders

Aging Clinical Trial

— GT  

Official title:

The Effect of Green Tea on Anthropometric, Oxidation and Inflammation Parameters in Physically Active Elderly Compared to Sedentary Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02077660
• Other study ID #: 01
• Secondary ID: Rambam MC
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: March 11, 2014
• Start date: November 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the beneficial effects of a long term (12 weeks) green tea drinking on plasma, erythrocytes and saliva oxidative stress biomarkers and antioxidant capacity, as well as on cardiometabolic risk factors: anthropometric, inflammation and metabolic parameters in a healthy aging men and women.

Description:

A prospective, crossover trial in which every individual served its own control. All subjects undergo a four weeks washout period, during which they briefed to avoid tea drinking and antioxidant supplements until the end of the study. At the end of the washout period, blood and saliva samples is collected after 12 hours of night fast. Subsequently, all subjects receive the maltodextrin containing placebo "tea bags". The subjects instructed to brew the placebo sachets for five minute in 240 mL boiling water without stirring and to drink 4 cups per day for 12 weeks period (placebo period). After the placebo period, fasting samples collected once more and the subjects receive the green tea bags. Preparation and drinking instructions are the same as the placebo drink. At the end of the 12 weeks, green tea drinking, fasting blood and saliva samples drawn for the third time. During the study, every 4 weeks the subjects get additional placebo or green tea bags. Assessment of nutritional consumption of macronutrients and antioxidants using a food diary, physical activity lifestyle as well as weight, body fat and circumference measurements is made at the beginning, middle and end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 76 Years

Eligibility

Inclusion Criteria:

• Healthy men and women

• Age: 60-76 Years

• Able to understand the meaning of Informed Consent procedure and willing to consent

Exclusion Criteria:

• Any active disease state

• Unstable chronic disease (diabetes, vascular, renal)

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Four green tea bags per day for 12 weeks
Four green tea bags per day for 12 weeks

Other:
• 4 daily placebo tea bags for 12 weeks
4 daily placebo tea bags for 12 weeks

Locations

Country	Name	City	State
Israel	Rambam MC	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma protein carbonyls	Protein carbonyls, nmol/mg	24 weeks	No
Primary	Plasma thiobarbituric acid reactive substance	Thiobarbituric acid reactive substance , nmol/mL	24 weeks	No
Primary	Plasma lipid peroxides	Lipid peroxides, nmol/mL	24 weeks	No
Primary	Erythrocytes catalase	Catalase activity, milliunits/mg	24 weeks	No
Primary	Erythrocytes resistance to oxidative hemolysis	hemolysis test, percentage	24 weeks	No
Primary	Saliva enzymatic antioxidants	Oral peroxidase activity, milliunits/mg	24 weeks	No
Primary	Saliva antioxidant capacity	Total antioxidant capacity, millimolar/mg	24 weeks	No
Secondary	Total body weight	Body weight, kg	24 weeks	No
Secondary	Total body fat percentage	Body fat, %	24 weeks	No
Secondary	Body circumference	Waist and hip circumference, cm	24 weeks	No
Secondary	Serum inflammatory status	Serum C-reactive protein mg/dL	24 weeks	No
Secondary	Saliva inflammatory status Saliva matrix metalloproteinase 8 (MMP8)	Saliva matrix metalloproteinase 8, µg/L	24 weeks	No
Secondary	Saliva inflammatory status - saliva interleukin 8 (IL8)	Saliva interleukin 8, ng/L	24 weeks	No