Back to resultsThe Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni in Patients With Type II Diabetes Mellitus (MOROLSTEVER1)
Primary Purpose
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
Status
Completed
Phase
Phase 4
Locations
Cameroon
Study Type
Interventional
Intervention
MOROLSTEVER1
Sponsored by
About this trial
This is an interventional treatment trial for 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 focused on measuring Diastolic function, Blood pressure profile, moringa oleifera, Stevia rebaudiana bertoni, Diabetes mellitus
Eligibility Criteria
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
Sites / Locations
- Yaounde Central Hospital, NAtional Obesity Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non-randomized single-arm of MOROLSTEVER1
Arm Description
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.
Outcomes
Primary Outcome Measures
Variation of mitral E' velocity
The mitral E' velocity is one of the methods for evaluating diastolic function.
Secondary Outcome Measures
Variation of transmitral flow parameters such as E velocity
E (early diastolic filling velocity)
Urinary excretion of albumin
Urinary excretion of albumin level
Variation of blood pressure.
Change in systolic and diastolic blood pressure by using ABPM (mmHg)
Full Information
NCT ID
NCT04254029
First Posted
January 31, 2020
Last Updated
January 31, 2020
Sponsor
Yaounde Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04254029
Brief Title
The Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni in Patients With Type II Diabetes Mellitus
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yaounde Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Diastolic function, Blood pressure profile, moringa oleifera, Stevia rebaudiana bertoni, Diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-randomized single-arm of MOROLSTEVER1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
MOROLSTEVER1
Intervention Description
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.
Primary Outcome Measure Information:
Title
Variation of mitral E' velocity
Description
The mitral E' velocity is one of the methods for evaluating diastolic function.
Time Frame
45 days
Secondary Outcome Measure Information:
Title
Variation of transmitral flow parameters such as E velocity
Description
E (early diastolic filling velocity)
Time Frame
45 days
Title
Urinary excretion of albumin
Description
Urinary excretion of albumin level
Time Frame
45 days
Title
Variation of blood pressure.
Description
Change in systolic and diastolic blood pressure by using ABPM (mmHg)
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yaounde Central Hospital, NAtional Obesity Center
City
Yaounde
Country
Cameroon
12. IPD Sharing Statement
Learn more about this trial
The Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni in Patients With Type II Diabetes Mellitus
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