Effect of Standardized Hibiscus Sabdariffa Tea in Seemingly Healthy Human Volunteers

Healthy Human Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04339283
• Other study ID #: Hibiscus-tea Study
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: April 2020
• Source: University of Ibadan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Human Volunteers

Intervention

Dietary Supplement:
• Standardized Hibiscus sabdariffa tea
Daily consumption of Standardized Hibiscus sabdariffa tea

Locations

Country	Name	City	State
Nigeria	Department of Clinical Pharmacy Laboratory, University of Ibadan	Ibadan	Oyo

Sponsors (1)

Lead Sponsor	Collaborator
University of Ibadan

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change form Baseline Hematocrit on the 14th day	Hematocrit was analysed in the laboratory and measured in % on the 14th day	14 days
Primary	Change form Baseline Hematocrit on the 28th day	Hematocrit was analysed in the laboratory and measured in % on the 28th day	28 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change form Baseline Pulse on the 14th day	Pulse was measured with the BP monitor in /min on the 14th day	14 days
Primary	Change form Baseline Pulse on the 28th day	Pulse was measured with the BP monitor in /min on the 28th day	28 days
Secondary	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
Secondary	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