Effect of Standardized Hibiscus Sabdariffa Tea in Seemingly Healthy Human Volunteers

NCT ID: NCT04339283

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2019-10-30

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.

Conditions

Healthy Human Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Standardized Hibiscus sabdariffa tea

Intervention Type: DIETARY_SUPPLEMENT

Daily consumption of Standardized Hibiscus sabdariffa tea

Water Arm

300 mL of distilled water is administered to the participants daily for 28 days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Standardized Hibiscus sabdariffa tea

Daily consumption of Standardized Hibiscus sabdariffa tea

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ibadan

OTHER

Sponsor Role: lead

Responsible Party

SEGUN SHOWANDE

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Segun J Showande, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Ibadan

Locations

Department of Clinical Pharmacy Laboratory, University of Ibadan

Ibadan, Oyo State, Nigeria

Countries

Nigeria

References

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.

Reference Type: DERIVED

PMID: 34837382 (View on PubMed)

Other Identifiers

Hibiscus-tea Study

Identifier Type: -

Identifier Source: org_study_id