HypertensionNCT02578927
Green Tea Attenuates Pressure Reduction Induced by a Session of Physical Exercise
A study testing GT+Ex, PL+Ex and Green Tea in people with Hypertension, run by Federal University of Paraíba.
Trial summary
The objective is to investigate whether the ingestion of green tea prior to physical exercise improvement post-exercise hypotension (PEH). Double-blind, randomized, placebo study. Read more about this study
- Who is it for?
- Ages 40 to 59 years
- Conditions the study is for
- Hypertension
- What is being tested?
- GT+Ex, PL+Ex and Green Tea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2015
- 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 40 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hypertensive
- Physically active for at least 3 months
- Not diabetics individuals.
Who cannot join
- Modifying the therapeutic treatment during the study
- Use beta-blocker drugs, and calcium channel blockers
- Menopausal women.
About this study
The objective is to investigate whether the ingestion of green tea prior to physical exercise improvement post-exercise hypotension (PEH). Double-blind, randomized, placebo study. Fifteen hypertensive (53±4.5 years) performed three procedures: green tea+exercise (GT+Ex), placebo+exercise (PL+Ex), green tea without exercise (GT). Thirty minutes after ingesting 2g of green tea or placebo, they performed treadmill walking (60 minutes), 60 to 85% of maximum heart rate intensity in procedures with exercises. BP was measured at rest and at every 10 minutes after exercise (60 minutes). Blood samples were taken before the ingestion of green tea or placebo and immediately after exercise to determine Malondialdehyde (MDA) and Nitrite (NO) dosages. Reduction of systolic BP compared with the rest, during PL+Ex recovery procedure.
Read the detailed description
Subjects of study: Double- blind study, randomized and placebo, conduced with fifteen both sexes hypertensive individuals, physically active and practitioners of exercises for at least 3 months prior to trials. All patients were users of anti- hypertensive medication except beta- blockers and maintained medication throughout study period. They were demanded not to be diabetic and women not menopaused. The research was approved by the Ethics Committee on Research with Human Beings of the Health Sciences Centre at the Federal University of Paraiba- CEP/ CCS, under the protocol 0120/13. Individuals were required to sign The Free and Clarified Consent Term (FCCT), according to resolution 196/96 of National Health Council.
Study Designs: subjects performed three experimental procedures, two practicing aerobic exercises and one without physical exercises. The sessions with exercises were conducted under previous administration of a green tea dosage or placebo (GT+Ex or PL+Ex), ingested 30 minutes before the start of exercises protocol. In the session without exercises (GT) they ingested green tea and remained sit during the same period destined to the exercises. Heart Rate Measurement were registered at rest (RHR) and in every ten minutes during physical exercise protocol. BP measurements were taken before (at rest), immediately after exercise and in every ten minutes during a recovery period of 60 minutes after the end of exercise protocol, or in the period they remained sit. Blood samples were collected prior and immediately after exercise or period without exercise for analysis of plasmatic concentration of anti and pro- oxidant agents (nitrite- NO and Malondialdehyde- MDA).
Instruments and Procedures:Physical Exercises: After the purposes of the research were clarified to the individuals, they were invited to proceed to the laboratory in order for exercise sessions performance. The groups were submitted to three sessions, two of those on treadmill aerobic exercise during 60 minutes. Furthermore, it was established that the individuals should practice exercises scoring between 11 and 14 in Borg and Noble's Subjective Perceived Exertion Scale. They were requested to hold the intensity of physical exercises from 60% to 85% of HRmax (maximum Heart Rate), monitored during sessions with a Polar frequency meter model RS800CX (Polar ElectroOy, Kempele, Finland).
Supplementation of Green Tea or Placebo: Green tea and placebo capsules were produced in a compounding laboratory. The investigators used 2g of green tea dried leaves and discovered an improvement in oxidative stress. The group with green tea consumption ingested capsules with 2g of concentrated powder, approximately 1960mg in polyphenols (636mg of epigallocatechin gallate) and 20mg of caffeine; placebo group consumed capsules containing 2g of cornstarch powder, all swallowed with water. Capsules were administered to patients after a skilled professional collected blood samples. Researchers conducted supplementation of substances after pre- exercise blood collection and sessions initiated only 30 minutes after the ingestion of capsules, which is the time required by the body to absorb nutrients.
Blood Pressure Measurement: Individuals had their BPs checked previously, immediately after the end of the exercise and during 60 minutes post- exercise. BP at rest was verified after the subjects remained sit for 10 minutes. By the end of the walking session, BP was checked with sitting subjects. During recovery, BP was verified in every 10 minutes during all 60 minutes of walking session. The protocol adopted was the one proposed by the Brazilian Society of Cardiology and the Brazilian Society of Hypertension.
Blood Collection Protocol: Performed prior and immediately after exercise. Ten milliliters (ml) of blood were collected from the antecubital vein, of which five ml were placed in test tubes containing EDTA and carefully homogenized by inversion. The other five ml were placed in tubes without any anticoagulant. Then they were centrifuged at 1500 rpm for 20 minutes. Plasma was isolated, placed in ependorf tubes and refrigerated in 20 ºC until analysis.
Evaluation of oxidative stress (MDA): Oxidizing activity was quantified through thiobarbituric acid reaction with the products from hydroperoxides decomposition. Therefore, 250 µl of sample was added to KCl and incubated in water bath maintained at 37° C for 60 minutes. Then mixture was precipitated with 35% AA perchloric and centrifuged at 14000 rpm and 4°C for 10 minutes. Supernatant was transferred to new ependorfs, adding 400 µl of 0.6% thiobarbituric acid and incubated at 95-100° C for 30 min. After cooling, material was read by spectrophotometer at a wavelength of 532nm.
Nitrite Dosage The method was based on the Griess reagent usage. Reagent was prepared utilizing equal parts of 5% phosphoric acid, 0.1% N-1-naphthalenediamine (NEED), 1% sulphanilamide, 5% in phosphoric acid and distilled water. To accomplish the test, 100 µl of 10% homogenate supernatant made with potassium phosphate buffer was added to 100µl Griess reagent. Regarding the white one, 100 µl reagent was added to 100 µl of buffer and series of dilutions were conducted to obtain standard curve (100, 50, 25 12.5, 6.25, 3.12, 1.56 µm) of nitrite. The entire test was executed in a 96 well- plate template with reader at an absorbance range of 560 nm.
Data Analysis Process: Initially, all data were tested concerned its normality and variability in standard error. Subsequently, one-way ANOVA tests were applied in order to compare basal conditions within three days of proceedings. Instat 3.0 software (GraphPAdInstat, San Diego, CA, USA) was utilized during analysis.
- Conditions
- Hypertension
- Being tested
- GT+Ex, PL+Ex, Green Tea
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT+ExDietary supplement
In this session the volunteers ingested capsules with 2g of powder green tea before exercise
PL+ExDietary supplement
In this session the volunteers ingested capsules with 2g of placebo before exercise
Green TeaDietary supplement
In this investigation the volunteers ingested capsules with 2g of powder green tea before the rest similar to the exercise time
| Study group | Role | What they receive |
|---|---|---|
| GT+Ex | Experimental | Ingestion of one dose of 2 g of green tea (GT) ingested at 10 minutes after the period of rest. After the Ingestion, the volunteers practice aerobic exercise (EX) in treadmill. Receives: Dietary Supplement: GT+Ex |
| PL+Ex | Placebo comparator | Ingestion of one dose 2 g of placebo (PL) ingested at 10 minutes after the period of rest. After the Ingestion, the volunteers practice aerobic exercise (EX) in treadmill. Receives: Dietary Supplement: PL+Ex |
| Green Tea | Active comparator | Ingestion of one dose 2g of green tea (GT) at 10 minutes after the period of rest. In this section the volunteers does not practice aerobic exercise. Receives: Dietary Supplement: Green Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
The sessions of exercise were released with interval of 30 days between them, thus each volunteer devoted an average 40 days to the study.
Measured: Change from baseline Bood Pressure at 60 minutes post exercise in the same experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manoel Miranda Neto, Federal University of Paraíba
- Investigators
- Manoel Miranda Neto, graduation, Principal investigator, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578927
- Sponsor's protocol ID
- FUParaíba
- Status last verified
- Oct 2015
- First submitted
- 11 Sep 2015
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Tea Attenuates Pressure Reduction Induced by a Session of Physical Exercise
- ClinicalTrials.gov ID
- NCT02578927
- Acronym / sponsor ID
- FUParaíba
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Oct 2015 (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 objective is to investigate whether the ingestion of green tea prior to physical exercise improvement post-exercise hypotension (PEH). Double-blind, randomized, placebo study. Fifteen hypertensive (53±4.5 years) performed three procedures: green tea+exercise (GT+Ex), placebo+exercise (PL+Ex), green tea without exercise (GT). Thirty minutes after ingesting 2g of green tea or placebo, they performed treadmill walking (60 minutes), 60 to 85% of maximum heart rate intensity in procedures with exercises. BP was measured at rest and at every 10 minutes after exercise (60 minutes). Blood samples were taken before the ingestion of green tea or placebo and immediately after exercise to determine Malondialdehyde (MDA) and Nitrite (NO) dosages. Reduction of systolic BP compared with the rest, during PL+Ex recovery procedure.
Detailed description
Subjects of study: Double- blind study, randomized and placebo, conduced with fifteen both sexes hypertensive individuals, physically active and practitioners of exercises for at least 3 months prior to trials. All patients were users of anti- hypertensive medication except beta- blockers and maintained medication throughout study period. They were demanded not to be diabetic and women not menopaused. The research was approved by the Ethics Committee on Research with Human Beings of the Health Sciences Centre at the Federal University of Paraiba- CEP/ CCS, under the protocol 0120/13. Individuals were required to sign The Free and Clarified Consent Term (FCCT), according to resolution 196/96 of National Health Council.
Study Designs: subjects performed three experimental procedures, two practicing aerobic exercises and one without physical exercises. The sessions with exercises were conducted under previous administration of a green tea dosage or placebo (GT+Ex or PL+Ex), ingested 30 minutes before the start of exercises protocol. In the session without exercises (GT) they ingested green tea and remained sit during the same period destined to the exercises. Heart Rate Measurement were registered at rest (RHR) and in every ten minutes during physical exercise protocol. BP measurements were taken before (at rest), immediately after exercise and in every ten minutes during a recovery period of 60 minutes after the end of exercise protocol, or in the period they remained sit. Blood samples were collected prior and immediately after exercise or period without exercise for analysis of plasmatic concentration of anti and pro- oxidant agents (nitrite- NO and Malondialdehyde- MDA).
Instruments and Procedures:Physical Exercises: After the purposes of the research were clarified to the individuals, they were invited to proceed to the laboratory in order for exercise sessions performance. The groups were submitted to three sessions, two of those on treadmill aerobic exercise during 60 minutes. Furthermore, it was established that the individuals should practice exercises scoring between 11 and 14 in Borg and Noble's Subjective Perceived Exertion Scale. They were requested to hold the intensity of physical exercises from 60% to 85% of HRmax (maximum Heart Rate), monitored during sessions with a Polar frequency meter model RS800CX (Polar ElectroOy, Kempele, Finland).
Supplementation of Green Tea or Placebo: Green tea and placebo capsules were produced in a compounding laboratory. The investigators used 2g of green tea dried leaves and discovered an improvement in oxidative stress. The group with green tea consumption ingested capsules with 2g of concentrated powder, approximately 1960mg in polyphenols (636mg of epigallocatechin gallate) and 20mg of caffeine; placebo group consumed capsules containing 2g of cornstarch powder, all swallowed with water. Capsules were administered to patients after a skilled professional collected blood samples. Researchers conducted supplementation of substances after pre- exercise blood collection and sessions initiated only 30 minutes after the ingestion of capsules, which is the time required by the body to absorb nutrients.
Blood Pressure Measurement: Individuals had their BPs checked previously, immediately after the end of the exercise and during 60 minutes post- exercise. BP at rest was verified after the subjects remained sit for 10 minutes. By the end of the walking session, BP was checked with sitting subjects. During recovery, BP was verified in every 10 minutes during all 60 minutes of walking session. The protocol adopted was the one proposed by the Brazilian Society of Cardiology and the Brazilian Society of Hypertension.
Blood Collection Protocol: Performed prior and immediately after exercise. Ten milliliters (ml) of blood were collected from the antecubital vein, of which five ml were placed in test tubes containing EDTA and carefully homogenized by inversion. The other five ml were placed in tubes without any anticoagulant. Then they were centrifuged at 1500 rpm for 20 minutes. Plasma was isolated, placed in ependorf tubes and refrigerated in 20 ºC until analysis.
Evaluation of oxidative stress (MDA): Oxidizing activity was quantified through thiobarbituric acid reaction with the products from hydroperoxides decomposition. Therefore, 250 µl of sample was added to KCl and incubated in water bath maintained at 37° C for 60 minutes. Then mixture was precipitated with 35% AA perchloric and centrifuged at 14000 rpm and 4°C for 10 minutes. Supernatant was transferred to new ependorfs, adding 400 µl of 0.6% thiobarbituric acid and incubated at 95-100° C for 30 min. After cooling, material was read by spectrophotometer at a wavelength of 532nm.
Nitrite Dosage The method was based on the Griess reagent usage. Reagent was prepared utilizing equal parts of 5% phosphoric acid, 0.1% N-1-naphthalenediamine (NEED), 1% sulphanilamide, 5% in phosphoric acid and distilled water. To accomplish the test, 100 µl of 10% homogenate supernatant made with potassium phosphate buffer was added to 100µl Griess reagent. Regarding the white one, 100 µl reagent was added to 100 µl of buffer and series of dilutions were conducted to obtain standard curve (100, 50, 25 12.5, 6.25, 3.12, 1.56 µm) of nitrite. The entire test was executed in a 96 well- plate template with reader at an absorbance range of 560 nm.
Data Analysis Process: Initially, all data were tested concerned its normality and variability in standard error. Subsequently, one-way ANOVA tests were applied in order to compare basal conditions within three days of proceedings. Instat 3.0 software (GraphPAdInstat, San Diego, CA, USA) was utilized during analysis.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GT+Ex | Experimental | Dietary Supplement: GT+ExIngestion of one dose of 2 g of green tea (GT) ingested at 10 minutes after the period of rest. After the Ingestion, the volunteers practice aerobic exercise (EX) in treadmill. |
| PL+Ex | Placebo comparator | Dietary Supplement: PL+ExIngestion of one dose 2 g of placebo (PL) ingested at 10 minutes after the period of rest. After the Ingestion, the volunteers practice aerobic exercise (EX) in treadmill. |
| Green Tea | Active comparator | Dietary Supplement: Green TeaIngestion of one dose 2g of green tea (GT) at 10 minutes after the period of rest. In this section the volunteers does not practice aerobic exercise. |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hypertensive
- Physically active for at least 3 months
- Not diabetics individuals.
Key exclusion criteria (3 listed)
- Modifying the therapeutic treatment during the study
- Use beta-blocker drugs, and calcium channel blockers
- Menopausal women.
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 |
|---|---|---|
| GT+ExIn this session the volunteers ingested capsules with 2g of powder green tea before exercise | Dietary supplement | GT+Ex |
| PL+ExIn this session the volunteers ingested capsules with 2g of placebo before exercise | Dietary supplement | PL+Ex |
| Green TeaIn this investigation the volunteers ingested capsules with 2g of powder green tea before the rest similar to the exercise time | Dietary supplement | Green Tea |
Primary outcome
Blood Pressure
Time frame: Change from baseline Bood Pressure at 60 minutes post exercise in the same experimental session
The sessions of exercise were released with interval of 30 days between them, thus each volunteer devoted an average 40 days to the study.
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 19 Oct 2015.
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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.
Manoel Miranda Neto, graduation principal investigator
Federal University of Paraíba
Questions about this trial
What is this clinical trial studying?
A study testing GT+Ex, PL+Ex and Green Tea in people with Hypertension, run by Federal University of Paraíba.
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 3 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 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Blood Pressure (time frame: Change from baseline Bood Pressure at 60 minutes post exercise in the same experimental session). 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 19 Oct 2015; AzTrials last refreshed its copy on 7 Nov 2026.