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

NCT ID: NCT02077660

Last Updated: 2014-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-02-28

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.

Conditions

Aging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: PLACEBO_COMPARATOR

4 daily placebo tea bags for 12 weeks

Intervention Type: OTHER

4 daily placebo tea bags 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).

Group Type: EXPERIMENTAL

Four green tea bags per day for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Four green tea bags per day for 12 weeks

Interventions

Four green tea bags per day for 12 weeks

Four green tea bags per day for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

4 daily placebo tea bags for 12 weeks

4 daily placebo tea bags for 12 weeks

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yishai Levy, Professor

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Rambam MC

Haifa, , Israel

Countries

Israel

Other Identifiers

Rambam MC

Identifier Type: OTHER

Identifier Source: secondary_id

01

Identifier Type: -

Identifier Source: org_study_id