Type 2 DiabetesNCT06517602
Effect of Moringa Oleifera Leaves on Glycemic Control of Women With Type 2 Diabetes
A study testing Supplementation of Moringa oleifera leaf powder in people with Type 2 Diabetes, run by University of Milan at 1 site in Algeria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Supplementation of Moringa oleifera leaf powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteAlgeria
- Study dates
- 7 Nov 2019to 23 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of type 1 diabetes
- Pregnancy or lactation
- Treatment with insulin.
Trial locations and contacts
1 site in 1 country.
Algeria1 site
Dispensaris of Edchedería, Bir Lehlu, Mahbes, and Farsia (Smara camp)
Tindouf
About this study
Official title: 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?
Read more
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Supplementation of Moringa oleifera leaf powder
- Keywords
- Moringa oleifera, Type 2 diabetes, Humans, Glucose, HbA1c
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation of Moringa oleifera leaf powderDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Moringa | Experimental | The experimental group received for 3 months a daily supplementation of 10g of Moringa oleifera leaf powder to consume within the two main meals. Receives: Dietary Supplement: Supplementation of Moringa oleifera leaf powder |
| Control | No intervention | The control group were asked to refrain from consuming Moringa oleifera leaves throughout the study period (3 months). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin (HbA1c)
Measured: Glycosylated hemoglobin was measured at recruitment and at the end of the study (three months)
Fasting glucose
Measured: Fasting glucose was measured at recruitment and at the end of the study (three months)
Secondary outcomes (5)
BMI
Measured: BMI were measured at recruitment and at the end of the study (3 months)
Waist circumference
Measured: Waist circumference were measured at recruitment and at the end of the study (3 months)
Hip circumference
Measured: Hip circumference were measured at recruitment and at the end of the study (3 months)
% body fat
Measured: % of body fat were measured at recruitment and at the end of the study (3 months)
Blood pressure
Systolic and diastolic blood pressure
Measured: Systolic and diastolic blood pressure were measured at recruitment and at the end of the study (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start7 Nov 2019
- Primary completion23 Feb 2020
- Study completion23 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Battezzati, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517602
- Sponsor's protocol ID
- 10-11-2018
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Consumption of Moringa Oleifera Leaves on Glycemic Control of Saharawi Women With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06517602
- Acronym / sponsor ID
- 10-11-2018
- Conditions
- Type 2 Diabetes
- Keywords
- Moringa oleifera, Type 2 diabetes, Humans, Glucose, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 23 Feb 2020 (actual)
- Study completion
- 23 Feb 2020 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moringa | Experimental | Dietary Supplement: Supplementation of Moringa oleifera leaf powderThe experimental group received for 3 months a daily supplementation of 10g of Moringa oleifera leaf powder to consume within the two main meals. |
| Control | No intervention | –The control group were asked to refrain from consuming Moringa oleifera leaves throughout the study period (3 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Diagnosis of type 1 diabetes
- Pregnancy or lactation
- Treatment with insulin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplementation of Moringa oleifera leaf powderWomen 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. | Dietary supplement | Moringa |
Primary outcome
Glycosylated hemoglobin (HbA1c)
Time frame: 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)
5 secondary outcomes
BMI
Time frame: 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)
Hip circumference
Time frame: 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)
Blood pressure
Time frame: Systolic and diastolic blood pressure were measured at recruitment and at the end of the study (3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementation of Moringa oleifera leaf powder in people with Type 2 Diabetes, run by University of Milan at 1 site in Algeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin (HbA1c) (time frame: Glycosylated hemoglobin was measured at recruitment and at the end of the study (three months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.