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Effect of Standardized Hibiscus Sabdariffa Tea in Seemingly Healthy Human Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04339283
Recruitment Status : Completed
First Posted : April 9, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
SEGUN SHOWANDE, University of Ibadan

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Human Volunteers Dietary Supplement: Standardized Hibiscus sabdariffa tea Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Standardized Hibiscus Sabdariffa Linn Tea, Potential Nutraceutical Candidate for the Prevention of Hypertension, Diabetes, and Hypercholesterolemia - a Pilot Study
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standardized Hibiscus sabdariffa tea Arm
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
Dietary Supplement: Standardized Hibiscus sabdariffa tea
Daily consumption of Standardized Hibiscus sabdariffa tea

No Intervention: Water Arm
300 mL of distilled water is administered to the participants daily for 28 days.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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


Secondary Outcome Measures :
  1. Change from Baseline Body Mass Index on the 14th day [ Time Frame: 14 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

  2. Change from Baseline Body Mass Index on the 28th day [ Time Frame: 28 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers only
  • Not on any medications or herbs
  • No disease condition
  • Females not pregnant
  • Non-smokers

Exclusion Criteria:

  • Below 18yrs or above 40 years
  • presence of chronic disease
  • on medications pregnant females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339283


Locations
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Nigeria
Department of Clinical Pharmacy Laboratory, University of Ibadan
Ibadan, Oyo, Nigeria, 200284
Sponsors and Collaborators
University of Ibadan
Investigators
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Principal Investigator: Segun J Showande, Ph.D University of Ibadan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SEGUN SHOWANDE, Dr., University of Ibadan
ClinicalTrials.gov Identifier: NCT04339283    
Other Study ID Numbers: Hibiscus-tea Study
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No