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Completed

NCT Number: NCT04254016

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

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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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yaounde Central Hospital, NAtional Obesity Center

Yaoundé, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIBISTEVER1

Dietary Supplement

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.

Primary outcomes

  1. Variation of mitral E' velocity

    Time frame: 8 weeks

    The mitral E' velocity is one of the methods for evaluating diastolic function.

Secondary outcomes

  1. Urinary excretion of albumin

    Time frame: 8 weeks

    Urinary excretion of albumin level

  2. Variation of transmitral flow parameters such as E velocity

    Time frame: 8 weeks

    E (early diastolic filling velocity)

  3. Variation of blood pressure.

    Time frame: 8 weeks

    Change in systolic and diastolic blood pressure by using ABPM (mmHg)

  4. Variation of lipid profile.

    Time frame: 8 weeks

    Change of triglycerides, LDL cholesterol, HDL cholesterol

Sponsors and collaborators

Lead sponsor

Yaounde Central Hospital

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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