Standardized Hibiscus Sabdariffa Linn Tea, Potential Nutraceutical Candidate for the Prevention of Hypertension, Diabetes, and Hypercholesterolemia - a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Ibadan
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change form Baseline Hemoglobin on the 28th day
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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
Intervention: Standardized Hibiscus sabdariffa tea (Dietary Supplement)
Water Arm
300 mL of distilled water is administered to the participants daily for 28 days.
Outcomes
Primary Outcomes
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 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 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 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 28th day
Time Frame: 28 days
Total Serum Cholesterol was analysed with Randox kit and measured in mg/dL 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 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 Pulse on the 28th day
Time Frame: 28 days
Pulse was measured with the BP monitor in /min on the 28th day
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
Secondary Outcomes
- Change from Baseline Body Mass Index on the 28th day(28 day)
- Change from Baseline Body Mass Index on the 14th day(14 day)
Investigators
SEGUN SHOWANDE
Dr.
University of Ibadan