Effect of Standardized Hibiscus Sabdariffa Tea in Seemingly Healthy Human Volunteers

• ClinicalTrials.gov Identifier: NCT04339283
• Recruitment Status: Completed
• First Posted: April 9, 2020
• Last Update Posted: April 9, 2020
• Sponsor: University of Ibadan
• Information provided by (Responsible Party): SEGUN SHOWANDE, University of Ibadan

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Nigeria

Department of Clinical Pharmacy Laboratory, University of Ibadan

Ibadan, Oyo, Nigeria, 200284

Sponsors and Collaborators

University of Ibadan

Investigators

• Principal Investigator: Segun J Showande, Ph.D; University of Ibadan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: SEGUN SHOWANDE, Dr., University of Ibadan
• ClinicalTrials.gov Identifier: NCT04339283
• Other Study ID Numbers: Hibiscus-tea Study
• First Posted: April 9, 2020
• Last Update Posted: April 9, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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