NCT04254029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 31, 2020

Last Update Submit

January 31, 2020

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

Keywords

Diastolic functionBlood pressure profilemoringa oleiferaStevia rebaudiana bertoniDiabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Variation of mitral E' velocity

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

    45 days

Secondary Outcomes (3)

  • Variation of transmitral flow parameters such as E velocity

    45 days

  • Urinary excretion of albumin

    45 days

  • Variation of blood pressure.

    45 days

Study Arms (1)

Non-randomized single-arm of MOROLSTEVER1

EXPERIMENTAL

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

Interventions

MOROLSTEVER1DIETARY_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.

Non-randomized single-arm of MOROLSTEVER1

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yaounde Central Hospital, NAtional Obesity Center

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, Principal investigator

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

November 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

CA(1)