AgingGTNCT02077660
Green Tea Effect on Anthropometric, Oxidation and Inflammation Parameters in Physically Active vs. Sedentary Elders
A study testing Four green tea bags per day for 12 weeks in people with Aging, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Four green tea bags per day for 12 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women
- Age: 60-76 Years
- Able to understand the meaning of Informed Consent procedure and willing to consent
Who cannot join
- Any active disease state
- Unstable chronic disease (diabetes, vascular, renal)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Green Tea on Anthropometric, Oxidation and Inflammation Parameters in Physically Active Elderly Compared to Sedentary Elderly
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Four green tea bags per day for 12 weeks, 4 daily placebo tea bags for 12 weeks
- Keywords
- Green tea, aging, oxidation, anthropometrics.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four green tea bags per day for 12 weeksDietary supplement
Four green tea bags per day for 12 weeks
4 daily placebo tea bags for 12 weeksOther
4 daily placebo tea bags for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: Four green tea bags per day for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma protein carbonyls
Protein carbonyls, nmol/mg
Measured: 24 weeks
Plasma thiobarbituric acid reactive substance
Thiobarbituric acid reactive substance , nmol/mL
Measured: 24 weeks
Plasma lipid peroxides
Lipid peroxides, nmol/mL
Measured: 24 weeks
Erythrocytes catalase
Catalase activity, milliunits/mg
Measured: 24 weeks
Erythrocytes resistance to oxidative hemolysis
hemolysis test, percentage
Measured: 24 weeks
Saliva enzymatic antioxidants
Oral peroxidase activity, milliunits/mg
Measured: 24 weeks
Saliva antioxidant capacity
Total antioxidant capacity, millimolar/mg
Measured: 24 weeks
Secondary outcomes (6)
Total body weight
Body weight, kg
Measured: 24 weeks
Total body fat percentage
Body fat, %
Measured: 24 weeks
Body circumference
Waist and hip circumference, cm
Measured: 24 weeks
Serum inflammatory status
Serum C-reactive protein mg/dL
Measured: 24 weeks
Saliva inflammatory status Saliva matrix metalloproteinase 8 (MMP8)
Saliva matrix metalloproteinase 8, µg/L
Measured: 24 weeks
Saliva inflammatory status - saliva interleukin 8 (IL8)
Saliva interleukin 8, ng/L
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startNov 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yishai Levy, Professor, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077660
- Sponsor's protocol ID
- 01
- Other IDs
- Rambam MC
- Acronym
- GT
- Status last verified
- Mar 2014
- First submitted
- 12 Feb 2014
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Green Tea on Anthropometric, Oxidation and Inflammation Parameters in Physically Active Elderly Compared to Sedentary Elderly
- ClinicalTrials.gov ID
- NCT02077660
- Acronym / sponsor ID
- GT / 01
- Conditions
- Aging
- Keywords
- Green tea, aging, oxidation, anthropometrics.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 daily placebo tea bags for 12 weeks | Placebo comparator | Other: 4 daily placebo tea bags for 12 weeksAll 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). |
| Four green tea bags per day for 12 weeks | Experimental | Dietary Supplement: Four green tea bags per day for 12 weeksAfter 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). |
Who may qualify
- Ages
- 60 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy men and women
- Age: 60-76 Years
- Able to understand the meaning of Informed Consent procedure and willing to consent
Key exclusion criteria (2 listed)
- Any active disease state
- Unstable chronic disease (diabetes, vascular, renal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four green tea bags per day for 12 weeksFour 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 weeks4 daily placebo tea bags for 12 weeks | Other | 4 daily placebo tea bags for 12 weeks |
Primary outcome
Plasma protein carbonyls
Time frame: 24 weeks
Protein carbonyls, nmol/mg
Plasma thiobarbituric acid reactive substance
Time frame: 24 weeks
Thiobarbituric acid reactive substance , nmol/mL
Plasma lipid peroxides
Time frame: 24 weeks
Lipid peroxides, nmol/mL
Erythrocytes catalase
Time frame: 24 weeks
Catalase activity, milliunits/mg
Erythrocytes resistance to oxidative hemolysis
Time frame: 24 weeks
hemolysis test, percentage
Saliva enzymatic antioxidants
Time frame: 24 weeks
Oral peroxidase activity, milliunits/mg
Saliva antioxidant capacity
Time frame: 24 weeks
Total antioxidant capacity, millimolar/mg
6 secondary outcomes
Total body weight
Time frame: 24 weeks
Total body fat percentage
Time frame: 24 weeks
Body circumference
Time frame: 24 weeks
Serum inflammatory status
Time frame: 24 weeks
Saliva inflammatory status Saliva matrix metalloproteinase 8 (MMP8)
Time frame: 24 weeks
Saliva inflammatory status - saliva interleukin 8 (IL8)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
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Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yishai Levy, Professor principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four green tea bags per day for 12 weeks in people with Aging, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma protein carbonyls (time frame: 24 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.