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

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ClinicalTrials.gov Identifier: NCT02077660
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Aging Dietary Supplement: Four green tea bags per day for 12 weeks Other: 4 daily placebo tea bags for 12 weeks Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Green Tea on Anthropometric, Oxidation and Inflammation Parameters in Physically Active Elderly Compared to Sedentary Elderly
Study Start Date : November 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   60 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077660


Locations
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Israel
Rambam MC
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Yishai Levy, Professor Rambam Health Care Campus

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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02077660     History of Changes
Other Study ID Numbers: 01
Rambam MC ( Other Identifier: Rambam MC )
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014

Keywords provided by Rambam Health Care Campus:
Green tea, aging, oxidation, anthropometrics.

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes