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

NCT ID: NCT04254029

Last Updated: 2020-02-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2017-05-01

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MOROLSTEVER1

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yaounde Central Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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CN NGANOU-GNINDJIO, MD, MSc

Dr, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yaounde Central Hospital, NAtional Obesity Center

Yaoundé, , Cameroon

Site Status

Countries

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Cameroon

Other Identifiers

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MOROLSTEVER1

Identifier Type: -

Identifier Source: org_study_id

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