The Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni in Patients With Type II Diabetes Mellitus

Benefits of a Capsules of Moringa Oleifera and Stevia Rebaudiana Bertoni in Patients With Type 2 Diabetes Mellitus Before and After 45 Days of add-on Therapy Clinical Trial

— MOROLSTEVER1  

Official title:

Short Term Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni as add-on Therapy in a Population of Type II Diabetes Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254029
• Other study ID #: MOROLSTEVER1
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: January 2020
• Source: Yaounde Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study was the evaluation of cardiovascular and renal benefits of moringa oleifera and stevia rebaudiana Bertoni in patients with type 2 diabetes mellitus before and after 8 weeks of add-on therapy.

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 daily consummation of 425 ml of drink containing the extracts of 1,38mg of leaves extracts of moringa oleifera and 23,46 mg of stevia rebaudiana Bertoni leaves extracts lasting 45 days. 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 for safety purposes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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 moringa or stevia supplementation or other herbal medication drugs that could interact with moringa 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 moringa or stevia Discontinued intervention

• Withdrawal of consent

Related Conditions & MeSH terms

• Benefits of a Capsules of Moringa Oleifera and Stevia Rebaudiana Bertoni in Patients With Type 2 Diabetes Mellitus Before and After 45 Days of add-on Therapy
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• MOROLSTEVER1
The intervention consisted of a daily consummation of 425 ml of drink containing the extracts of 1,38mg of leaves extracts of moringa oleifera and 23,46 mg of stevia rebaudiana Bertoni leaves extracts lasting 45 days.

Locations

Country	Name	City	State
Cameroon	Yaounde Central Hospital, NAtional Obesity Center	Yaounde

Sponsors (1)

Lead Sponsor	Collaborator
Yaounde Central Hospital

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of mitral E' velocity	The mitral E' velocity is one of the methods for evaluating diastolic function.	45 days
Secondary	Variation of transmitral flow parameters such as E velocity	E (early diastolic filling velocity)	45 days
Secondary	Urinary excretion of albumin	Urinary excretion of albumin level	45 days
Secondary	Variation of blood pressure.	Change in systolic and diastolic blood pressure by using ABPM (mmHg)	45 days