Healthy Human VolunteersNCT04339283
Effect of Standardized Hibiscus Sabdariffa Tea in Seemingly Healthy Human Volunteers
A study testing Standardized Hibiscus sabdariffa tea in people with Healthy Human Volunteers, run by University of Ibadan at 1 site in Nigeria.
Trial summary
Hibiscus sabdariffa tea is commonly used all over the world by healthy individual but the tea is also employed by patients in the management of chronic diseases such as hypertension diabetes, high cholesterol, liver disease etc. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Human Volunteers
- What is being tested?
- Standardized Hibiscus sabdariffa tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Sep 2019to 30 Oct 2019
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers only
- Not on any medications or herbs
- No disease condition
- Females not pregnant
- Non-smokers
Who cannot join
- Below 18yrs or above 40 years
- presence of chronic disease
- on medications pregnant females
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Department of Clinical Pharmacy Laboratory, University of Ibadan
Ibadan, Oyo State, 200284
About this study
Official title: Standardized Hibiscus Sabdariffa Linn Tea, Potential Nutraceutical Candidate for the Prevention of Hypertension, Diabetes, and Hypercholesterolemia - a Pilot Study
Hibiscus sabdariffa tea is commonly used all over the world by healthy individual but the tea is also employed by patients in the management of chronic diseases such as hypertension diabetes, high cholesterol, liver disease etc. Several studies in humans and animal have proved the efficacy of Hibiscus sabdariffa tea in lowering blood pressure, blood glucose level and serum total cholesterol. But no study exists on the effect of daily consumption of this tea on blood pressure, blood glucose, total cholesterol and other biochemical and hematological parameters in healthy humans. Hence this study.
Read the detailed description
Several studies have been carried out on the effect of the water beverage of Hibiscus sabdariffa, most focus on hypertensive patients, diabetic patients and obese patient and some studies investigated the hypolipidemic a effect of the water beverage of Hibiscus sabdariffa as well as its effect on haematological parameters but mice were used for these studies. Little or no investigation has been done to assess the safety of daily consumption of this water beverage of hibiscus sabdariffa on humans.
Hence, this study aims at investigating the safety in the daily consumption of Zobo in humans, monitoring lipid profile, blood pressure, blood glucose, body mass index and haematological parameters such as haematocrit, haemoglobin, total white blood cells and also hepatic indices.
- Conditions
- Healthy Human Volunteers
- Being tested
- Standardized Hibiscus sabdariffa tea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Hibiscus sabdariffa teaDietary supplement
Daily consumption of Standardized Hibiscus sabdariffa tea
| Study group | Role | What they receive |
|---|---|---|
| Standardized Hibiscus sabdariffa tea Arm | Experimental | 300 mL of freshly prepared standardized Hibiscus sabdariffa tea (containing 102.49 mg/L of total monomeric anthocyanin) is administered daily to the participants for 28 days Receives: Dietary Supplement: Standardized Hibiscus sabdariffa tea |
| Water Arm | No intervention | 300 mL of distilled water is administered to the participants daily for 28 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure on the 14th day
Blood pressure was measured in mmHg at baseline and on the 14th day of study with the aid of Omron Digital Blood pressure monitor
Measured: 14 days
Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure on the 28th day
Systolic and Diastolic Blood pressures were measured in mmHg at baseline and on the 28th day of study with the aid of Omron Digital Blood pressure monitor
Measured: 28 days
Change from Baseline Fasting Blood Glucose level on the 14th day
Fating blood glucose level was measured with AccuChek Active glucometer in mg/dL on the 14th day of study
Measured: 14 days
Change from Baseline Fasting Blood Glucose level on the 28th day
Fating blood glucose level was measured with AccuChek Active glucometer in mg/dL on the 28th day of study
Measured: 28 days
Change from Baseline Total Serum Cholesterol on the 14th day
Total Serum Cholesterol was analysed with Randox kit and measured in mg/dL on the 14th day
Measured: 14 days
Change from Baseline Total Serum Cholesterol on the 28th day
Total Serum Cholesterol was analysed with Randox kit and measured in mg/dL on the 28th day
Measured: 28 days
Change from Baseline Triglyceride on the 14th day
Triglyceride was analysed with Randox kit and measured in mg/dL on the 14th day
Measured: 14 days
Change from Baseline Triglyceride on the 28th day
Triglyceride was analysed with Randox kit and measured in mg/dL on the 28th day
Measured: 28 days
Change from Baseline High Density Lipoprotein Cholesterol on the 14th day
High Density Lipoprotein Cholesterol was analysed with Randox kit and measured in mg/dL on the 14th day
Measured: 14 days
Change from Baseline High Density Lipoprotein Cholesterol on the 28th day
High Density Lipoprotein Cholesterol was analysed with Randox kit and measured in mg/dL on the 28th day
Measured: 28 days
Change from Baseline Low Density Lipoprotein Cholesterol on the 14th day
Low Density Lipoprotein Cholesterol was analysed with Randox kit and measured in mg/dL on the 14th day
Measured: 14 days
Change from Baseline Low Density Lipoprotein Cholesterol on the 28th day
Low Density Lipoprotein Cholesterol was analysed with Randox kit and measured in mg/dL on the 28th day
Measured: 28 days
Change form Baseline Alanine Aminotransferase on the 14th day
Alanine aminotransferase was analysed with Randox kit and measured in U/L on the 14th day
Measured: 14 days
Change form Baseline Alanine Aminotransferase on the 28th day
Alanine aminotransferase was analysed with Randox kit and measured in U/L on the 28th day
Measured: 28 days
Change form Baseline Aspartate Aminotransferase on the 14th day
Aspartate aminotransferase was analysed with Randox kit and measured in U/L on the 14th day
Measured: 14 days
Change form Baseline Aspartate Aminotransferase on the 28th day
Aspartate aminotransferase was analysed with Randox kit and measured in U/L on the 28th day
Measured: 28 days
Change form Baseline Blood Urea Nitrogen on the 14th day
Blood Urea Nitrogen was analysed with Randox kit and measured in mg/dL on the 14th day
Measured: 14 days
Change form Baseline Blood Urea Nitrogen on the 28th day
Blood Urea Nitrogen was analysed with Randox kit and measured in mg/dL on the 28th day
Measured: 28 days
Change form Baseline Serum Creatinine on the 14th day
Serum Creatinine was analysed with Randox kit and measured in mg/dL on the 14th day
Measured: 14 days
Change form Baseline Serum Creatinine on the 28th day
Serum Creatinine was analysed with Randox kit and measured in mg/dL on the 28th day
Measured: 28 days
Change form Baseline Albumin on the 14th day
Albumin was analysed with Randox kit and measured in g/dL on the 14th day
Measured: 14 days
Change form Baseline Albumin on the 28th day
Albumin was analysed with Randox kit and measured in g/dL on the 28th day
Measured: 28 days
Change form Baseline Hematocrit on the 14th day
Hematocrit was analysed in the laboratory and measured in % on the 14th day
Measured: 14 days
Change form Baseline Hematocrit on the 28th day
Hematocrit was analysed in the laboratory and measured in % on the 28th day
Measured: 28 days
Change form Baseline Hemoglobin on the 14th day
Hemoglobin was analysed in the laboratory and measured in g/dL on the 14th day
Measured: 14 days
Change form Baseline Hemoglobin on the 28th day
Hemoglobin was analysed in the laboratory and measured in g/dL on the 28th day
Measured: 28 days
Change form Baseline White Blood Cell count on the 14th day
White Blood Cell counts was analysed in the laboratory and measured in 10*3/ µL on the 14th day
Measured: 14 days
Change form Baseline White Blood Cell count on the 28th day
White Blood Cell counts was analysed in the laboratory and measured in 10*3/ µL on the 28th day
Measured: 28 days
Change form Baseline Total Protein on the 14th day
Total Protein was analysed in the laboratory and measured in g/dL on the 14th day
Measured: 14 days
Change form Baseline Total Protein on the 28th day
Total Protein was analysed in the laboratory and measured in g/dL on the 28th day
Measured: 28 days
Change form Baseline Pulse on the 14th day
Pulse was measured with the BP monitor in /min on the 14th day
Measured: 14 days
Change form Baseline Pulse on the 28th day
Pulse was measured with the BP monitor in /min on the 28th day
Measured: 28 days
Secondary outcomes (2)
Change from Baseline Body Mass Index on the 14th day
Body mass index measure in kg/sq m was calculated from a measure of weight in kg and height in meters on the 14 day
Measured: 14 day
Change from Baseline Body Mass Index on the 28th day
Body mass index measure in kg/sq m was calculated from a measure of weight in kg and height in meters on the 14 day
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Sep 2019
- Primary completion30 Sep 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Human VolunteersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ibadan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEGUN SHOWANDE, University of Ibadan
- Investigators
- Segun J Showande, Ph.D, Principal investigator, University of Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339283
- Sponsor's protocol ID
- Hibiscus-tea Study
- Status last verified
- Apr 2020
- First submitted
- 31 Mar 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pattanittum P, Ngamjarus C, Buttramee F, Somboonporn C. Roselle for hypertension in adults. Cochrane Database Syst Rev. 2021 Nov 27;11(11):CD007894. doi: 10.1002/14651858.CD007894.pub3.
PubMed 34837382
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Hibiscus Sabdariffa Linn Tea, Potential Nutraceutical Candidate for the Prevention of Hypertension, Diabetes, and Hypercholesterolemia - a Pilot Study
- ClinicalTrials.gov ID
- NCT04339283
- Acronym / sponsor ID
- Hibiscus-tea Study
- Conditions
- Healthy Human Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of IbadanUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 9 Apr 2020 (actual)
- 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.
Hibiscus sabdariffa tea is commonly used all over the world by healthy individual but the tea is also employed by patients in the management of chronic diseases such as hypertension diabetes, high cholesterol, liver disease etc. Several studies in humans and animal have proved the efficacy of Hibiscus sabdariffa tea in lowering blood pressure, blood glucose level and serum total cholesterol. But no study exists on the effect of daily consumption of this tea on blood pressure, blood glucose, total cholesterol and other biochemical and hematological parameters in healthy humans. Hence this study.
Detailed description
Several studies have been carried out on the effect of the water beverage of Hibiscus sabdariffa, most focus on hypertensive patients, diabetic patients and obese patient and some studies investigated the hypolipidemic a effect of the water beverage of Hibiscus sabdariffa as well as its effect on haematological parameters but mice were used for these studies. Little or no investigation has been done to assess the safety of daily consumption of this water beverage of hibiscus sabdariffa on humans.
Hence, this study aims at investigating the safety in the daily consumption of Zobo in humans, monitoring lipid profile, blood pressure, blood glucose, body mass index and haematological parameters such as haematocrit, haemoglobin, total white blood cells and also hepatic indices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Hibiscus sabdariffa tea Arm | Experimental | Dietary Supplement: Standardized Hibiscus sabdariffa tea300 mL of freshly prepared standardized Hibiscus sabdariffa tea (containing 102.49 mg/L of total monomeric anthocyanin) is administered daily to the participants for 28 days |
| Water Arm | No intervention | –300 mL of distilled water is administered to the participants daily for 28 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers only
- Not on any medications or herbs
- No disease condition
- Females not pregnant
- Non-smokers
Key exclusion criteria (3 listed)
- Below 18yrs or above 40 years
- presence of chronic disease
- on medications pregnant females
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 |
|---|---|---|
| Standardized Hibiscus sabdariffa teaDaily consumption of Standardized Hibiscus sabdariffa tea | Dietary supplement | Standardized Hibiscus sabdariffa tea Arm |
Primary outcome
Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure on the 14th day
Time frame: 14 days
Blood pressure was measured in mmHg at baseline and on the 14th day of study with the aid of Omron Digital Blood pressure monitor
Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure on the 28th day
Time frame: 28 days
Systolic and Diastolic Blood pressures were measured in mmHg at baseline and on the 28th day of study with the aid of Omron Digital Blood pressure monitor
Change from Baseline Fasting Blood Glucose level on the 14th day
Time frame: 14 days
Fating blood glucose level was measured with AccuChek Active glucometer in mg/dL on the 14th day of study
Change from Baseline Fasting Blood Glucose level on the 28th day
Time frame: 28 days
Fating blood glucose level was measured with AccuChek Active glucometer in mg/dL on the 28th day of study
Change from Baseline Total Serum Cholesterol on the 14th day
Time frame: 14 days
Total Serum Cholesterol was analysed with Randox kit and measured in mg/dL on the 14th day
Change from Baseline Total Serum Cholesterol on the 28th day
Time frame: 28 days
Total Serum Cholesterol was analysed with Randox kit and measured in mg/dL on the 28th day
Change from Baseline Triglyceride on the 14th day
Time frame: 14 days
Triglyceride was analysed with Randox kit and measured in mg/dL on the 14th day
Change from Baseline Triglyceride on the 28th day
Time frame: 28 days
Triglyceride was analysed with Randox kit and measured in mg/dL on the 28th day
Change from Baseline High Density Lipoprotein Cholesterol on the 14th day
Time frame: 14 days
High Density Lipoprotein Cholesterol was analysed with Randox kit and measured in mg/dL on the 14th day
Change from Baseline High Density Lipoprotein Cholesterol on the 28th day
Time frame: 28 days
High Density Lipoprotein Cholesterol was analysed with Randox kit and measured in mg/dL on the 28th day
Change from Baseline Low Density Lipoprotein Cholesterol on the 14th day
Time frame: 14 days
Low Density Lipoprotein Cholesterol was analysed with Randox kit and measured in mg/dL on the 14th day
Change from Baseline Low Density Lipoprotein Cholesterol on the 28th day
Time frame: 28 days
Low Density Lipoprotein Cholesterol was analysed with Randox kit and measured in mg/dL on the 28th day
Change form Baseline Alanine Aminotransferase on the 14th day
Time frame: 14 days
Alanine aminotransferase was analysed with Randox kit and measured in U/L on the 14th day
Change form Baseline Alanine Aminotransferase on the 28th day
Time frame: 28 days
Alanine aminotransferase was analysed with Randox kit and measured in U/L on the 28th day
Change form Baseline Aspartate Aminotransferase on the 14th day
Time frame: 14 days
Aspartate aminotransferase was analysed with Randox kit and measured in U/L on the 14th day
Change form Baseline Aspartate Aminotransferase on the 28th day
Time frame: 28 days
Aspartate aminotransferase was analysed with Randox kit and measured in U/L on the 28th day
Change form Baseline Blood Urea Nitrogen on the 14th day
Time frame: 14 days
Blood Urea Nitrogen was analysed with Randox kit and measured in mg/dL on the 14th day
Change form Baseline Blood Urea Nitrogen on the 28th day
Time frame: 28 days
Blood Urea Nitrogen was analysed with Randox kit and measured in mg/dL on the 28th day
Change form Baseline Serum Creatinine on the 14th day
Time frame: 14 days
Serum Creatinine was analysed with Randox kit and measured in mg/dL on the 14th day
Change form Baseline Serum Creatinine on the 28th day
Time frame: 28 days
Serum Creatinine was analysed with Randox kit and measured in mg/dL on the 28th day
Change form Baseline Albumin on the 14th day
Time frame: 14 days
Albumin was analysed with Randox kit and measured in g/dL on the 14th day
Change form Baseline Albumin on the 28th day
Time frame: 28 days
Albumin was analysed with Randox kit and measured in g/dL on the 28th day
Change form Baseline Hematocrit on the 14th day
Time frame: 14 days
Hematocrit was analysed in the laboratory and measured in % on the 14th day
Change form Baseline Hematocrit on the 28th day
Time frame: 28 days
Hematocrit was analysed in the laboratory and measured in % on the 28th day
Change form Baseline Hemoglobin on the 14th day
Time frame: 14 days
Hemoglobin was analysed in the laboratory and measured in g/dL on the 14th day
Change form Baseline Hemoglobin on the 28th day
Time frame: 28 days
Hemoglobin was analysed in the laboratory and measured in g/dL on the 28th day
Change form Baseline White Blood Cell count on the 14th day
Time frame: 14 days
White Blood Cell counts was analysed in the laboratory and measured in 10*3/ µL on the 14th day
Change form Baseline White Blood Cell count on the 28th day
Time frame: 28 days
White Blood Cell counts was analysed in the laboratory and measured in 10*3/ µL on the 28th day
Change form Baseline Total Protein on the 14th day
Time frame: 14 days
Total Protein was analysed in the laboratory and measured in g/dL on the 14th day
Change form Baseline Total Protein on the 28th day
Time frame: 28 days
Total Protein was analysed in the laboratory and measured in g/dL on the 28th day
Change form Baseline Pulse on the 14th day
Time frame: 14 days
Pulse was measured with the BP monitor in /min on the 14th day
Change form Baseline Pulse on the 28th day
Time frame: 28 days
Pulse was measured with the BP monitor in /min on the 28th day
2 secondary outcomes
Change from Baseline Body Mass Index on the 14th day
Time frame: 14 day
Change from Baseline Body Mass Index on the 28th day
Time frame: 28 day
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 9 Apr 2020.
- Derived from this study: PubMed 34837382Pattanittum P, Ngamjarus C, Buttramee F, Somboonporn C. Roselle for hypertension in adults. Cochrane Database Syst Rev. 2021 Nov 27;11(11):CD007894. doi: 10.1002/14651858.CD007894.pub3.
- Individual participant dataSharing planned: No
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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.
Segun J Showande, Ph.D principal investigator
University of Ibadan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Hibiscus sabdariffa tea in people with Healthy Human Volunteers, run by University of Ibadan at 1 site in Nigeria.
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 5 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 9 Apr 2020. 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 Nigeria. 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. 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?
Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure on the 14th day (time frame: 14 days). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04339283, which also lists 1 linked publication.
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 9 Apr 2020.