Benefits of a Hibiscus Sabdariffa and Stevia Rebaudiana Drink in Patients With Type 2 Diabetes Mellitus Before and After 8 Weeks of add-on Therapy
Conditions
Keywords
Diastolic function, Blood pressure, Diabetes mellitus, Hibiscus Sabdariffa, Stevia Rebaudiana
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTHIBISTEVER1
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.
Sponsors
Yaounde Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Known T2DM patients aged above 21years No change in anti-diabetic medication during the last three months HbA1c between 42 to 64mmol/mol (6-8% Clearance of creatinine calculated according to the Modification of Diet in Renal Disease equation\> 60ml/min/1.73 m2
Exclusion criteria
* Patient already on Hibiscus or stevia supplementation or other herbal medication Drugs that could interact with hibiscus or whose effects may be amplified, as far back as 1 month before study. Cardiac, renal disease and liver pathologies Sensitivity, intolerance or allergy to hibiscus or stevia Discontinued intervention Withdrawal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of mitral E' velocity | 8 weeks | The mitral E' velocity is one of the methods for evaluating diastolic function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation of transmitral flow parameters such as E velocity | 8 weeks | E (early diastolic filling velocity) |
| Urinary excretion of albumin | 8 weeks | Urinary excretion of albumin level |
| Variation of blood pressure. | 8 weeks | Change in systolic and diastolic blood pressure by using ABPM (mmHg) |
| Variation of lipid profile. | 8 weeks | Change of triglycerides, LDL cholesterol, HDL cholesterol |
Countries
Cameroon
Outcome results
None listed