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

NCT02077660 | Completed

• 2 other identifiers: 01Rambam MC
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

Green tea, aging, oxidation, anthropometrics.

Outcome Measures

Primary Outcomes (7)

• Plasma protein carbonyls

  Protein carbonyls, nmol/mg

  24 weeks

• Plasma thiobarbituric acid reactive substance

  Thiobarbituric acid reactive substance , nmol/mL

  24 weeks

• Plasma lipid peroxides

  Lipid peroxides, nmol/mL

  24 weeks

• Erythrocytes catalase

  Catalase activity, milliunits/mg

  24 weeks

• Erythrocytes resistance to oxidative hemolysis

  hemolysis test, percentage

  24 weeks

• Saliva enzymatic antioxidants

  Oral peroxidase activity, milliunits/mg

  24 weeks

• Saliva antioxidant capacity

  Total antioxidant capacity, millimolar/mg

  24 weeks

Secondary Outcomes (6)

• Total body weight

  24 weeks

• Total body fat percentage

  24 weeks

• Body circumference

  24 weeks

• Serum inflammatory status

  24 weeks

• Saliva inflammatory status Saliva matrix metalloproteinase 8 (MMP8)

  24 weeks

Study Arms (2)

4 daily placebo tea bags for 12 weeks

PLACEBO COMPARATOR

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

Four green tea bags per day for 12 weeks

EXPERIMENTAL

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

Interventions

Four green tea bags per day for 12 weeks DIETARY_SUPPLEMENT

Four green tea bags per day for 12 weeks

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

4 daily placebo tea bags for 12 weeks

Eligibility Criteria

• Age: 60 Years - 76 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women
• Age: 60-76 Years
• Able to understand the meaning of Informed Consent procedure and willing to consent

You may not qualify if:

• Any active disease state
• Unstable chronic disease (diabetes, vascular, renal)

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam MC

Haifa, Israel

Location

Study Officials

• Yishai Levy, Professor

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: March 4, 2014
• Study Start: November 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 12, 2014

Record last verified: 2014-03

Locations

IL (1)