Clinical trial NCT02077660: Green Tea Effect on Anthropometric, Oxidation and Inflammation Parameters in Physically Active vs. Sedentary Elders
Official title: The Effect of Green Tea on Anthropometric, Oxidation and Inflammation Parameters in Physically Active Elderly Compared to Sedentary Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Green tea, aging, oxidation, anthropometrics.
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 43
Sex: ALL
Minimum age (years): 60
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Plasma protein carbonyls
timeFrame: 24 weeks
measure: Plasma thiobarbituric acid reactive substance
timeFrame: 24 weeks
measure: Plasma lipid peroxides
timeFrame: 24 weeks
measure: Erythrocytes catalase
timeFrame: 24 weeks
measure: Erythrocytes resistance to oxidative hemolysis
timeFrame: 24 weeks
measure: Saliva enzymatic antioxidants
timeFrame: 24 weeks
measure: Saliva antioxidant capacity
timeFrame: 24 weeks
Secondary outcomes:
measure: Total body weight
timeFrame: 24 weeks
measure: Total body fat percentage
timeFrame: 24 weeks
measure: Body circumference
timeFrame: 24 weeks
measure: Serum inflammatory status
timeFrame: 24 weeks
measure: Saliva inflammatory status Saliva matrix metalloproteinase 8 (MMP8)
timeFrame: 24 weeks
measure: Saliva inflammatory status - saliva interleukin 8 (IL8)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam MC
Study officials:
affiliation: Rambam Health Care Campus
name: Yishai Levy, Professor
role: PRINCIPAL_INVESTIGATOR
References: