Effect of Standardized Hibiscus Sabdariffa Tea in Seemingly Healthy Human Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Standardized Hibiscus Sabdariffa Linn Tea, Potential Nutraceutical Candidate for the Prevention of Hypertension, Diabetes, and Hypercholesterolemia - a Pilot Study

Conditions
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Healthy Human Volunteers

Intervention / Treatment
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* Dietary Supplement: Standardized Hibiscus sabdariffa tea


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized Hibiscus sabdariffa tea Arm<br>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<br>* Daily consumption of Standardized Hibiscus sabdariffa tea<br>|
| No Intervention: Water Arm<br>300 mL of distilled water is administered to the participants daily for 28 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 28 days | 
| Change form Baseline Hematocrit on the 14th day | Hematocrit was analysed in the laboratory and measured in % on the 14th day | 14 days | 
| Change form Baseline Hematocrit on the 28th day | Hematocrit was analysed in the laboratory and measured in % on the 28th day | 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 | 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 | 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 | 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 | 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 | 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 | 28 days | 
| Change form Baseline Pulse on the 14th day | Pulse was measured with the BP monitor in /min on the 14th day | 14 days | 
| Change form Baseline Pulse on the 28th day | Pulse was measured with the BP monitor in /min on the 28th day | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 28 day |