Effect of Moringa Oleifera Leaves on Glycemic Control of Women With Type 2 Diabetes

July 22, 2024 updated by: Alberto Battezzati, University of Milan

Effect of Daily Consumption of Moringa Oleifera Leaves on Glycemic Control of Saharawi Women With Type 2 Diabetes

The objective of this clinical trial was to understand whether supplementation of Moringa oleifera leaf powder improved glycemic management in Sahrawi women with type 2 diabetes living in refugee camps. The main question sought to be answered was:

- Does daily supplementation of Moringa oleifera leaf powder, in addition to oral hypoglycemic therapy, improve glycosylated hemoglobin and fasting blood glucose?

Researchers compared Moringa supplementation with no Moringa consumption to see if Moringa oleifera worked to improve glycemic control.

Participants had to:

  • Take Moringa oleifera leaves daily or abstain from consuming Moringa for 3 months.
  • Consistently take prescribed oral hypoglycemic agents
  • Undergo clinical examinations and measurement of biochemical, metabolic and body composition parameters at the time of recruitment and at the end of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Tindouf, Algeria
        • Dispensaris of Edchedería, Bir Lehlu, Mahbes, and Farsia (Smara camp)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of type 2 diabetes for at least 1 year
  • Absence of advanced retinopathy, terminal renal failure, active diabetic ulcers, amputations, and heart failure
  • Treatment with only oral hypoglycemic drugs.

Exclusion Criteria:

  • Diagnosis of type 1 diabetes
  • Pregnancy or lactation
  • Treatment with insulin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moringa
The experimental group received for 3 months a daily supplementation of 10g of Moringa oleifera leaf powder to consume within the two main meals.
Dietary supplement: Supplementation of Moringa oleifera leaf powder
Women in the experimental group were asked to consistently take the prescribed oral hypoglycemic therapy and to maintain their lifestyle and eating habits. In addition, for the duration of the study (3 months), the experimental group was provided with 10 g of Moringa oleifera leaf powder daily to be consumed with main meals.
No Intervention: Control
The control group were asked to refrain from consuming Moringa oleifera leaves throughout the study period (3 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycosylated hemoglobin (HbA1c)
Time Frame: Glycosylated hemoglobin was measured at recruitment and at the end of the study (three months)
Glycosylated hemoglobin was measured at recruitment and at the end of the study (three months)
Fasting glucose
Time Frame: Fasting glucose was measured at recruitment and at the end of the study (three months)
Fasting glucose was measured at recruitment and at the end of the study (three months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: BMI were measured at recruitment and at the end of the study (3 months)
BMI were measured at recruitment and at the end of the study (3 months)
Waist circumference
Time Frame: Waist circumference were measured at recruitment and at the end of the study (3 months)
Waist circumference were measured at recruitment and at the end of the study (3 months)
Hip circumference
Time Frame: Hip circumference were measured at recruitment and at the end of the study (3 months)
Hip circumference were measured at recruitment and at the end of the study (3 months)
% body fat
Time Frame: % of body fat were measured at recruitment and at the end of the study (3 months)
% of body fat were measured at recruitment and at the end of the study (3 months)
Blood pressure
Time Frame: Systolic and diastolic blood pressure were measured at recruitment and at the end of the study (3 months)
Systolic and diastolic blood pressure
Systolic and diastolic blood pressure were measured at recruitment and at the end of the study (3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2019

Primary Completion (Actual)

February 23, 2020

Study Completion (Actual)

February 23, 2020

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-11-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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