Clinical trial NCT04339283: Effect of Standardized Hibiscus Sabdariffa Tea in Seemingly Healthy Human Volunteers
Official title: Standardized Hibiscus Sabdariffa Linn Tea, Potential Nutraceutical Candidate for the Prevention of Hypertension, Diabetes, and Hypercholesterolemia - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Human Volunteers
Lead sponsor: University of Ibadan
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure on the 14th day
timeFrame: 14 days
measure: Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure on the 28th day
timeFrame: 28 days
measure: Change from Baseline Fasting Blood Glucose level on the 14th day
timeFrame: 14 days
measure: Change from Baseline Fasting Blood Glucose level on the 28th day
timeFrame: 28 days
measure: Change from Baseline Total Serum Cholesterol on the 14th day
timeFrame: 14 days
measure: Change from Baseline Total Serum Cholesterol on the 28th day
timeFrame: 28 days
measure: Change from Baseline Triglyceride on the 14th day
timeFrame: 14 days
measure: Change from Baseline Triglyceride on the 28th day
timeFrame: 28 days
measure: Change from Baseline High Density Lipoprotein Cholesterol on the 14th day
timeFrame: 14 days
measure: Change from Baseline High Density Lipoprotein Cholesterol on the 28th day
timeFrame: 28 days
measure: Change from Baseline Low Density Lipoprotein Cholesterol on the 14th day
timeFrame: 14 days
measure: Change from Baseline Low Density Lipoprotein Cholesterol on the 28th day
timeFrame: 28 days
measure: Change form Baseline Alanine Aminotransferase on the 14th day
timeFrame: 14 days
measure: Change form Baseline Alanine Aminotransferase on the 28th day
timeFrame: 28 days
measure: Change form Baseline Aspartate Aminotransferase on the 14th day
timeFrame: 14 days
measure: Change form Baseline Aspartate Aminotransferase on the 28th day
timeFrame: 28 days
measure: Change form Baseline Blood Urea Nitrogen on the 14th day
timeFrame: 14 days
measure: Change form Baseline Blood Urea Nitrogen on the 28th day
timeFrame: 28 days
measure: Change form Baseline Serum Creatinine on the 14th day
timeFrame: 14 days
measure: Change form Baseline Serum Creatinine on the 28th day
timeFrame: 28 days
measure: Change form Baseline Albumin on the 14th day
timeFrame: 14 days
measure: Change form Baseline Albumin on the 28th day
timeFrame: 28 days
measure: Change form Baseline Hematocrit on the 14th day
timeFrame: 14 days
measure: Change form Baseline Hematocrit on the 28th day
timeFrame: 28 days
measure: Change form Baseline Hemoglobin on the 14th day
timeFrame: 14 days
measure: Change form Baseline Hemoglobin on the 28th day
timeFrame: 28 days
measure: Change form Baseline White Blood Cell count on the 14th day
timeFrame: 14 days
measure: Change form Baseline White Blood Cell count on the 28th day
timeFrame: 28 days
measure: Change form Baseline Total Protein on the 14th day
timeFrame: 14 days
measure: Change form Baseline Total Protein on the 28th day
timeFrame: 28 days
measure: Change form Baseline Pulse on the 14th day
timeFrame: 14 days
measure: Change form Baseline Pulse on the 28th day
timeFrame: 28 days
Secondary outcomes:
measure: Change from Baseline Body Mass Index on the 14th day
timeFrame: 14 day
measure: Change from Baseline Body Mass Index on the 28th day
timeFrame: 28 day
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: Department of Clinical Pharmacy Laboratory, University of Ibadan
state: Oyo
Study officials:
affiliation: University of Ibadan
name: Segun J Showande, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.