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Completed

NCT Number: NCT02077660

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

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.

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Key information

Conditions

Age range

60 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam MC

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Four green tea bags per day for 12 weeks

Dietary Supplement

Four green tea bags per day for 12 weeks

4 daily placebo tea bags for 12 weeks

Other

4 daily placebo tea bags for 12 weeks

Primary outcomes

  1. Plasma protein carbonyls

    Time frame: 24 weeks

    Protein carbonyls, nmol/mg

  2. Plasma thiobarbituric acid reactive substance

    Time frame: 24 weeks

    Thiobarbituric acid reactive substance , nmol/mL

  3. Plasma lipid peroxides

    Time frame: 24 weeks

    Lipid peroxides, nmol/mL

  4. Erythrocytes catalase

    Time frame: 24 weeks

    Catalase activity, milliunits/mg

  5. Erythrocytes resistance to oxidative hemolysis

    Time frame: 24 weeks

    hemolysis test, percentage

  6. Saliva enzymatic antioxidants

    Time frame: 24 weeks

    Oral peroxidase activity, milliunits/mg

  7. Saliva antioxidant capacity

    Time frame: 24 weeks

    Total antioxidant capacity, millimolar/mg

Secondary outcomes

  1. Total body weight

    Time frame: 24 weeks

    Body weight, kg

  2. Total body fat percentage

    Time frame: 24 weeks

    Body fat, %

  3. Body circumference

    Time frame: 24 weeks

    Waist and hip circumference, cm

  4. Serum inflammatory status

    Time frame: 24 weeks

    Serum C-reactive protein mg/dL

  5. Saliva inflammatory status Saliva matrix metalloproteinase 8 (MMP8)

    Time frame: 24 weeks

    Saliva matrix metalloproteinase 8, µg/L

  6. Saliva inflammatory status - saliva interleukin 8 (IL8)

    Time frame: 24 weeks

    Saliva interleukin 8, ng/L

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Acronym: GT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 4, 2014
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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