Yaounde Central Hospital, NAtional Obesity Center
Yaoundé, Cameroon
NCT Number: NCT04254016
The aim of this study is to evaluate the effects of a Hibiscus Sabdariffa and Stevia Rebaudiana drink on cardiac relaxation and urinary albumin excretion in a group of diabetic type II patients.
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Notify Me21 year–75 year
All sexes
Interventional
Phase 4
Yaoundé, Cameroon
The investigators performed a non-randomized single-arm clinical trial with a before and after design, carried out from November 2016 and May 2017.
Intervention consisted of the administration of a Hibiscus-Stevia drink at a dose of 4 mg / kg / day for Stevia and 4 g / day for Hibiscus for a period of 8 weeks. Before and after intervention, the following were done by the participants: bioelectrical impedance analysis (BIA), blood pressure measurements, fasting blood sugar, HbA1c, lipid profiles, liver function tests, kidney function tests, urinary excretion of albumin tests and full blood counts. These were followed by morphological workup including Electrocardiograms (ECGs), transthoracic heart ultrasounds and Ambulatory Blood Pressure Measurements (ABPM), also done before and after intervention.
Clinical evaluation with fasting blood sugar control, blood pressure controls and urinary excretion albumin tests were done at the 30th and 60th days for safety purposes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cardiac, renal disease and liver pathologies Sensitivity, intolerance or allergy to hibiscus or stevia Discontinued intervention Withdrawal of consent
During 8 weeks, administration of a Hibiscus-Stevia drink for 8 weeks at a dose of 4 mg / kg / day for Stevia and 4 g / day for Hibiscus. Evaluation will take place the 30th and 60th days.
Time frame: 8 weeks
The mitral E' velocity is one of the methods for evaluating diastolic function.
Time frame: 8 weeks
Urinary excretion of albumin level
Time frame: 8 weeks
E (early diastolic filling velocity)
Time frame: 8 weeks
Change in systolic and diastolic blood pressure by using ABPM (mmHg)
Time frame: 8 weeks
Change of triglycerides, LDL cholesterol, HDL cholesterol
Yaounde Central Hospital
Other Gov
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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