The Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni in Patients With Type II Diabetes Mellitus (MOROLSTEVER1)

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

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.

Study Overview

• Status: Completed
• Conditions: 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
• Intervention / Treatment: Dietary supplement: MOROLSTEVER1

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• Cameroon
  • Yaounde, Cameroon
    • Yaounde Central Hospital, NAtional Obesity Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Non-randomized single-arm of MOROLSTEVER1; 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 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of mitral E' velocity	The mitral E' velocity is one of the methods for evaluating diastolic function.	45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of transmitral flow parameters such as E velocity	E (early diastolic filling velocity)	45 days
Urinary excretion of albumin	Urinary excretion of albumin level	45 days
Variation of blood pressure.	Change in systolic and diastolic blood pressure by using ABPM (mmHg)	45 days

Collaborators and Investigators

• Sponsor: Yaounde Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes mellitus; Diastolic function; Blood pressure profile; moringa oleifera; Stevia rebaudiana bertoni
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: MOROLSTEVER1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No