HealthyNCT02637570
Effect of Hibiscus Tea and Green Tea Supplements on Athletic Performance, Blood Pressure, Muscle Damage Indices and Oxidative Stress
A study testing Hibiscus tea and green tea in people with Healthy, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
This study evaluated effect of Hibiscus tea and green tea supplements on athletic performance, blood pressure, muscle damage indices and oxidative stress in male athletes 18-35 years old and cardiovascular disease prevention approach. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hibiscus tea and green tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Oct 2015to Dec 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 to 35 y/o
- no history of smoking or alcohol consumption
- no taking nutritional sport supplements during the last 2 months
Who cannot join
- any injury during intervention
- any inflammatory disease during the intervention
Trial locations and contacts
1 site in 1 country.
Iran1 site
male sports club members of Isfahan university of medical sciences
Isfahan
About this study
This study evaluated effect of Hibiscus tea and green tea supplements on athletic performance, blood pressure, muscle damage indices and oxidative stress in male athletes 18-35 years old and cardiovascular disease prevention approach.
- Conditions
- Healthy
- Being tested
- Hibiscus tea, green tea, placebo (dextrose)
- Keywords
- healthy male athletes, 18-35 years old
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hibiscus teaDietary supplement
green teaDietary supplement
placebo (dextrose)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Hibiscus tea | Experimental | 420 mg Hibiscus 2 hour after dinner with 1 glass of cool water every day Receives: Dietary Supplement: Hibiscus tea; Dietary Supplement: placebo (dextrose) |
| green tea | Experimental | 450 mg green tea 2 hour after dinner with 1 glass of cool water every day Receives: Dietary Supplement: green tea; Dietary Supplement: placebo (dextrose) |
| control group | Placebo comparator | 450 mg placebo (dextrose) 2 hour after dinner with 1 glass of cool water every day Receives: Dietary Supplement: Hibiscus tea; Dietary Supplement: green tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
athletic performance assess by heart rate in step test (Harvard test).
Measured: 6 weeks
blood pressure
Measured: 6 weeks
serum's malondialdehyde
it will asses by spectrophotometry.
Measured: 6 weeks
serum's lactate dehydrogenase
it will asses by calorimetry.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makan Pourmasoumi, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637570
- Sponsor's protocol ID
- 394423
- Status last verified
- Aug 2017
- First submitted
- 19 Oct 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hibiscus Tea and Green Tea Supplements on Athletic Performance, Blood Pressure, Muscle Damage Indices and Oxidative Stress
- ClinicalTrials.gov ID
- NCT02637570
- Acronym / sponsor ID
- 394423
- Conditions
- Healthy
- Keywords
- healthy male athletes, 18-35 years old
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Dec 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.
This study evaluated effect of Hibiscus tea and green tea supplements on athletic performance, blood pressure, muscle damage indices and oxidative stress in male athletes 18-35 years old and cardiovascular disease prevention approach.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hibiscus tea | Experimental | Dietary Supplement: Hibiscus tea, Dietary Supplement: placebo (dextrose)420 mg Hibiscus 2 hour after dinner with 1 glass of cool water every day |
| green tea | Experimental | Dietary Supplement: green tea, Dietary Supplement: placebo (dextrose)450 mg green tea 2 hour after dinner with 1 glass of cool water every day |
| control group | Placebo comparator | Dietary Supplement: Hibiscus tea, Dietary Supplement: green tea450 mg placebo (dextrose) 2 hour after dinner with 1 glass of cool water every day |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18 to 35 y/o
- no history of smoking or alcohol consumption
- no taking nutritional sport supplements during the last 2 months
Key exclusion criteria (2 listed)
- any injury during intervention
- any inflammatory disease during the intervention
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 |
|---|---|---|
| Hibiscus tea | Dietary supplement | Hibiscus tea, control group |
| green tea | Dietary supplement | control group, green tea |
| placebo (dextrose) | Dietary supplement | Hibiscus tea, green tea |
Primary outcome
athletic performance assess by heart rate in step test (Harvard test).
Time frame: 6 weeks
blood pressure
Time frame: 6 weeks
serum's malondialdehyde
Time frame: 6 weeks
it will asses by spectrophotometry.
serum's lactate dehydrogenase
Time frame: 6 weeks
it will asses by calorimetry.
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 11 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hibiscus tea and green tea in people with Healthy, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 11 Aug 2017. 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 Iran. 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?
athletic performance assess by heart rate in step test (Harvard test). (time frame: 6 weeks). The study lists 4 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 11 Aug 2017.