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OpenTrials
Completed

NCT Number: NCT06517602

Effect of Moringa Oleifera Leaves on Glycemic Control of 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Tindouf, Algeria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supplementation of Moringa oleifera leaf powder

Dietary Supplement

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.

Primary outcomes

  1. Glycosylated hemoglobin (HbA1c)

    Time frame: Glycosylated hemoglobin was measured at recruitment and at the end of the study (three months)

  2. Fasting glucose

    Time frame: Fasting glucose was measured at recruitment and at the end of the study (three months)

Secondary outcomes

  1. BMI

    Time frame: BMI were measured at recruitment and at the end of the study (3 months)

  2. Waist circumference

    Time frame: Waist circumference were measured at recruitment and at the end of the study (3 months)

  3. Hip circumference

    Time frame: Hip circumference were measured at recruitment and at the end of the study (3 months)

  4. % body fat

    Time frame: % of body fat were measured at recruitment and at the end of the study (3 months)

  5. 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

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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