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

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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Other: 4 daily placebo tea bags for 12 weeks; Dietary supplement: Four green tea bags per day for 12 weeks

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 4 daily placebo tea bags for 12 weeks; All subjects will undergo a 12 weeks supplemented with four daily placebo maltodextrin "tea-bags". The subjects will be instructed than 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).	Other: 4 daily placebo tea bags for 12 weeks; 4 daily placebo tea bags for 12 weeks
Experimental: Four green tea bags per day for 12 weeks; After the placebo period, all subjects will undergo a 12 weeks supplemented with four daily green tea bags. The subjects will be instructed than to brew the green tea sachets for five minute in 240 mL boiling water without stirring and to drink 4 cups per day for 12 weeks period (Green tea period).	Dietary supplement: Four green tea bags per day for 12 weeks; Four green tea bags per day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma protein carbonyls	Protein carbonyls, nmol/mg	24 weeks
Plasma thiobarbituric acid reactive substance	Thiobarbituric acid reactive substance , nmol/mL	24 weeks
Plasma lipid peroxides	Lipid peroxides, nmol/mL	24 weeks
Erythrocytes catalase	Catalase activity, milliunits/mg	24 weeks
Erythrocytes resistance to oxidative hemolysis	hemolysis test, percentage	24 weeks
Saliva enzymatic antioxidants	Oral peroxidase activity, milliunits/mg	24 weeks
Saliva antioxidant capacity	Total antioxidant capacity, millimolar/mg	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total body weight	Body weight, kg	24 weeks
Total body fat percentage	Body fat, %	24 weeks
Body circumference	Waist and hip circumference, cm	24 weeks
Serum inflammatory status	Serum C-reactive protein mg/dL	24 weeks
Saliva inflammatory status Saliva matrix metalloproteinase 8 (MMP8)	Saliva matrix metalloproteinase 8, µg/L	24 weeks
Saliva inflammatory status - saliva interleukin 8 (IL8)	Saliva interleukin 8, ng/L	24 weeks

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Yishai Levy, Professor, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: March 2, 2014
• First Posted (Estimate): March 4, 2014

Study Record Updates

• Last Update Posted (Estimate): March 12, 2014
• Last Update Submitted That Met QC Criteria: March 11, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Green tea, aging, oxidation, anthropometrics.
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 01 (Miami VAHS); Rambam MC (Other Identifier: Rambam MC)