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

Primary Purpose

Aging

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Four green tea bags per day for 12 weeks
4 daily placebo tea bags for 12 weeks
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring Green tea, aging, oxidation, anthropometrics.

Eligibility Criteria

60 Years - 76 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Rambam MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

4 daily placebo tea bags for 12 weeks

Four green tea bags per day for 12 weeks

Arm 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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2014
Last Updated
March 11, 2014
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02077660
Brief Title
Green Tea Effect on Anthropometric, Oxidation and Inflammation Parameters in Physically Active vs. Sedentary Elders
Acronym
GT
Official Title
The Effect of Green Tea on Anthropometric, Oxidation and Inflammation Parameters in Physically Active Elderly Compared to Sedentary Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging
Keywords
Green tea, aging, oxidation, anthropometrics.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 daily placebo tea bags for 12 weeks
Arm Type
Placebo Comparator
Arm 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).
Arm Title
Four green tea bags per day for 12 weeks
Arm Type
Experimental
Arm 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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Four green tea bags per day for 12 weeks
Intervention Description
Four green tea bags per day for 12 weeks
Intervention Type
Other
Intervention Name(s)
4 daily placebo tea bags for 12 weeks
Intervention Description
4 daily placebo tea bags for 12 weeks
Primary Outcome Measure Information:
Title
Plasma protein carbonyls
Description
Protein carbonyls, nmol/mg
Time Frame
24 weeks
Title
Plasma thiobarbituric acid reactive substance
Description
Thiobarbituric acid reactive substance , nmol/mL
Time Frame
24 weeks
Title
Plasma lipid peroxides
Description
Lipid peroxides, nmol/mL
Time Frame
24 weeks
Title
Erythrocytes catalase
Description
Catalase activity, milliunits/mg
Time Frame
24 weeks
Title
Erythrocytes resistance to oxidative hemolysis
Description
hemolysis test, percentage
Time Frame
24 weeks
Title
Saliva enzymatic antioxidants
Description
Oral peroxidase activity, milliunits/mg
Time Frame
24 weeks
Title
Saliva antioxidant capacity
Description
Total antioxidant capacity, millimolar/mg
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Total body weight
Description
Body weight, kg
Time Frame
24 weeks
Title
Total body fat percentage
Description
Body fat, %
Time Frame
24 weeks
Title
Body circumference
Description
Waist and hip circumference, cm
Time Frame
24 weeks
Title
Serum inflammatory status
Description
Serum C-reactive protein mg/dL
Time Frame
24 weeks
Title
Saliva inflammatory status Saliva matrix metalloproteinase 8 (MMP8)
Description
Saliva matrix metalloproteinase 8, µg/L
Time Frame
24 weeks
Title
Saliva inflammatory status - saliva interleukin 8 (IL8)
Description
Saliva interleukin 8, ng/L
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yishai Levy, Professor
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam MC
City
Haifa
Country
Israel

12. IPD Sharing Statement

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

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