Effect of Standardized Hibiscus Sabdariffa Tea in Seemingly Healthy Human Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Human Volunteers
• Intervention / Treatment: Dietary supplement: Standardized Hibiscus sabdariffa tea

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Oyo
    • Ibadan, Oyo, Nigeria, 200284
      • Department of Clinical Pharmacy Laboratory, University of Ibadan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 5, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 5, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Hibiscus-tea Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No