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

R

Rambam Health Care Campus

Status

Completed

Conditions

Aging

Treatments

Other: 4 daily placebo tea bags for 12 weeks
Dietary Supplement: Four green tea bags per day for 12 weeks

Study type

Interventional

Funder types

Other

Identifiers

NCT02077660
01
Rambam MC (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

60 to 76 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

43 participants in 2 patient groups, including a placebo group

4 daily placebo tea bags for 12 weeks
Placebo Comparator group
Description:
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).
Treatment:
Other: 4 daily placebo tea bags for 12 weeks
Four green tea bags per day for 12 weeks
Experimental group
Description:
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).
Treatment:
Dietary Supplement: Four green tea bags per day for 12 weeks

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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