Healthy Human Volunteers
Conditions
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.
Interventions
DIETARY_SUPPLEMENTStandardized Hibiscus sabdariffa tea
Daily consumption of Standardized Hibiscus sabdariffa tea
Sponsors
University of Ibadan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change form Baseline Pulse on the 28th day | 28 days | Pulse was measured with the BP monitor in /min on the 28th day |
| Change form Baseline Total Protein on the 28th day | 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 | 14 days | Pulse was measured with the BP monitor in /min on the 14th day |
| Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure on the 14th day | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 14 days | Hematocrit was analysed in the laboratory and measured in % on the 14th day |
| Change form Baseline Hematocrit on the 28th day | 28 days | Hematocrit was analysed in the laboratory and measured in % on the 28th day |
| Change form Baseline Hemoglobin on the 14th day | 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 | 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 | 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 | 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 | 14 days | Total Protein was analysed in the laboratory and measured in g/dL on the 14th day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Body Mass Index on the 28th day | 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 |
| Change from Baseline Body Mass Index on the 14th day | 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 |
Countries
Nigeria
Outcome results
None listed