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

Not Applicable

Completed

• Conditions: Aging
• Interventions: Other: 4 daily placebo tea bags for 12 weeks; Dietary Supplement: Four green tea bags per day for 12 weeks

• Registration Number: NCT02077660
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

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 Timeline

• Study Start: 2011-11
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-02-12
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-02
• Study First Posted: 2014-03-04
• Last Update Submitted: 2014-03-11
• Last Update Posted: 2014-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4 daily placebo tea bags for 12 weeks	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).
Four green tea bags per day for 12 weeks	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rambam MC; 🇮🇱 Haifa, Israel