Short Term Effects of a Hibiscus Sabdariffa and Stevia Rebaudiana Drink on Cardiac Relaxation and Urinary Albumin Excretion in a Group of Diabetic Type 2 Subjects
NCT ID: NCT04254016
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
22 participants
INTERVENTIONAL
2016-11-01
2017-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Non-randomized single-arm of HIBISTEVER1
Non-randomized single-arm clinical trial with a before and after design. The study population consisted on all type 2 diabetes mellitus (T2DM) patients with a target population of T2DM patients with HbA1c between 42 to 64mmol/mol (6-8%) with no change in anti-diabetic treatment during the last three months, previous the study.
The intervention consisted on the administration of 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 and after meals.
HIBISTEVER1
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.
Interventions
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HIBISTEVER1
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Cardiac, renal disease and liver pathologies Sensitivity, intolerance or allergy to hibiscus or stevia Discontinued intervention Withdrawal of consent
21 Years
75 Years
ALL
No
Sponsors
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Yaounde Central Hospital
OTHER_GOV
Responsible Party
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CN NGANOU-GNINDJIO, MD, MSc
Dr, Principal investigator
Locations
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Yaounde Central Hospital, NAtional Obesity Center
Yaoundé, , Cameroon
Countries
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Other Identifiers
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HIBISTEVER
Identifier Type: -
Identifier Source: org_study_id
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