PreDiabetesNUTRIMOL-DBNCT04734132
Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile in Prediabetic Patients
A study testing Moringa in people with PreDiabetes, run by National Research Council, Spain at 1 site in Spain.
Trial summary
Moringa oleifera (MO) is a traditional food in tropical and subtropical areas and has attained a growing interest for its medicinal properties. It's a nutrient-rich vegetable, high in protein and polyphenol content. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Moringa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jan 2019to 26 Jan 2021
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prediabetes: HbA1c between 5.7-6.4 % or fasting blood glucose between 100 - 125 mg/dl or impaired glucose tolerance (> 140 mg/dl and < 200 mg/dl two hours post oral challenge).
- No pharmacological treatment prescribed for glycemia control.
Who cannot join
- Diabetes Mellitus
- Impaired renal function: < 60% Glomerular filtration
- Uncontrolled high blood pressure
- Previous cardiovascular events or coronary disease
- Autoimmune disease
- HIV
Show all 14Show fewer
- Severe gastrointestinal disease
- Cancer
- Psychiatric illness
- Elevated liver enzymes (x2 normal range)
- Alcohol abuse (higher than 14 and 21 doses/week for women and men, respectively)
- Morbid obesity (BMI>35kg/m2)
- Pregnancy
- Pharmacological treatments that interfere with glucose control.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institute of Food Science and Technology and Nutrition (ICTAN)-CSIC
Madrid, 28040
About this study
Official title: Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile. Nutritional Intervention Study in Prediabetic Patients
Moringa oleifera (MO) is a traditional food in tropical and subtropical areas and has attained a growing interest for its medicinal properties. It's a nutrient-rich vegetable, high in protein and polyphenol content. The MO dry leaves and leaf extracts have been shown to exert numerous in vitro activities and in vivo effects, including the hypoglycemic effect. Thus, MO could be an alternative to prevent or treat diabetes. Studies in humans, however, are still limited. This proposal aims to study the efficacy of Moringa oleifera to improve the control of glycaemia in subjects with prediabetes. A 3-month dietary intervention with MO dry leave capsules will be performed and compared to placebo.
Read the detailed description
The tree Moringa oleifera (MO) is a traditional medicinal plant in tropical and subtropical areas, also consumed as food, which is currently expanding worldwide as a protein-rich leafy vegetable and for the medicinal value of its phytochemicals, in particular its glucosinolates. Specifically, MO dry leaves and leaf extracts have been shown to exert numerous in vitro activities and in vivo effects, including the hypoglycemic effect. Thus, MO could be an alternative to prevent or treat diabetes. In this sense, in vitro and preclinical experiments have shown that MO could potentially reverse some of the pathophysiological manifestation of diabetes and its comorbidities, such as hepatic fat accumulation and insulin resistance, oxidative stress, inflammation and peripheral hyperglycemia. Studies in humans, however, are still limited. This proposal aims to study the efficacy of Moringa oleifera to improve the control of glycaemia in subjects with prediabetes. A 3-month dietary intervention with MO dry leave capsules will be performed and compared to placebo. This will be a double-blind, randomized, placebo controlled, parallel group intervention study. Subjects will randomly consume either 6 capsules of dry MO leaves (400 mg dry leaf powder /capsule) or 6 placebo capsules per day during 3 months. The study subjects will provide samples for outcome measurements at three different time points: basal, 6 weeks and 12 weeks of supplementation. Glycaemia and plasma inflammatory and metabolic markers will be measured, as well as the gut microbiota composition.
- Conditions
- PreDiabetes
- Being tested
- Moringa, Placebo
- Keywords
- Moringa oleifera, functional food, anti-hyperglycemic effect, prevention, anti-inflammatory, microbiota, lipid metabolism
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoringaDietary supplement
Leaves of Moringa oleifera from an organic Iberian peninsula cultivar. A single lot was prepared from the same crop. Leaves were dried and ground and encapsulated as a organic dietary supplement. No other changes in diet or physical activity were included although a general healthy lifestyle pattern was recommended.
PlaceboDietary supplement
Placebo capsules were indistinguishable from the experimental capsules in material and color (opaque white). Same number of capsules were consumed as in the experimental arm and no other changes in diet or physical activity were included although a general healthy lifestyle pattern was recommended.
| Study group | Role | What they receive |
|---|---|---|
| Moringa | Experimental | Six Moringa oleifera capsules (400 mg dry leaf powder /capsule) consumed daily during 12 weeks. Two capsules consumed with each of the three main meals. Receives: Dietary Supplement: Moringa |
| Placebo | Placebo comparator | Six placebo capsules containing microcrystalline cellulose consumed daily during 12 weeks. Two capsules consumed with each of the three main meals. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose
Measured in serum samples from fasting blood withdrawn in a Sodium Fluoride vacutainer tube
Measured: 12 weeks
Glycated hemoglobin (HbA1C)
Measured in fasting serum
Measured: 12 weeks
Secondary outcomes (1)
Conversion rate from prediabetes to normal
Number of subjects in each arm that convert from prediabetic to normal glycemia
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start22 Jan 2019
- Primary completion5 May 2020
- Study completion26 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomized, parallel group, placebo-controlled dietary intervention in prediabetic subjects.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Esther Nova Rebato, National Research Council, Spain
- Investigators
- Esther NOVA, PhD, Principal investigator, National Research Council of Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734132
- Sponsor's protocol ID
- AGL2017-86044-C2-1-R
- Acronym
- NUTRIMOL-DB
- Status last verified
- Feb 2021
- First submitted
- 27 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Although a specific plan has not been conceived yet, sharing research data is a good practice that the investigators would pursue at due time.
Publications
Nova E, Redondo-Useros N, Martinez-Garcia RM, Gomez-Martinez S, Diaz-Prieto LE, Marcos A. Potential of Moringa oleifera to Improve Glucose Control for the Prevention of Diabetes and Related Metabolic Alterations: A Systematic Review of Animal and Human Studies. Nutrients. 2020 Jul 10;12(7):2050. doi: 10.3390/nu12072050.
PubMed 32664295Vargas-Sanchez K, Garay-Jaramillo E, Gonzalez-Reyes RE. Effects of Moringa oleifera on Glycaemia and Insulin Levels: A Review of Animal and Human Studies. Nutrients. 2019 Dec 2;11(12):2907. doi: 10.3390/nu11122907.
PubMed 31810205
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile. Nutritional Intervention Study in Prediabetic Patients
- ClinicalTrials.gov ID
- NCT04734132
- Acronym / sponsor ID
- NUTRIMOL-DB / AGL2017-86044-C2-1-R
- Conditions
- PreDiabetes
- Keywords
- Moringa oleifera, functional food, anti-hyperglycemic effect, prevention, anti-inflammatory, microbiota, lipid metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 2 Feb 2021 (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.
Moringa oleifera (MO) is a traditional food in tropical and subtropical areas and has attained a growing interest for its medicinal properties. It's a nutrient-rich vegetable, high in protein and polyphenol content. The MO dry leaves and leaf extracts have been shown to exert numerous in vitro activities and in vivo effects, including the hypoglycemic effect. Thus, MO could be an alternative to prevent or treat diabetes. Studies in humans, however, are still limited. This proposal aims to study the efficacy of Moringa oleifera to improve the control of glycaemia in subjects with prediabetes. A 3-month dietary intervention with MO dry leave capsules will be performed and compared to placebo.
Detailed description
The tree Moringa oleifera (MO) is a traditional medicinal plant in tropical and subtropical areas, also consumed as food, which is currently expanding worldwide as a protein-rich leafy vegetable and for the medicinal value of its phytochemicals, in particular its glucosinolates. Specifically, MO dry leaves and leaf extracts have been shown to exert numerous in vitro activities and in vivo effects, including the hypoglycemic effect. Thus, MO could be an alternative to prevent or treat diabetes. In this sense, in vitro and preclinical experiments have shown that MO could potentially reverse some of the pathophysiological manifestation of diabetes and its comorbidities, such as hepatic fat accumulation and insulin resistance, oxidative stress, inflammation and peripheral hyperglycemia. Studies in humans, however, are still limited. This proposal aims to study the efficacy of Moringa oleifera to improve the control of glycaemia in subjects with prediabetes. A 3-month dietary intervention with MO dry leave capsules will be performed and compared to placebo. This will be a double-blind, randomized, placebo controlled, parallel group intervention study. Subjects will randomly consume either 6 capsules of dry MO leaves (400 mg dry leaf powder /capsule) or 6 placebo capsules per day during 3 months. The study subjects will provide samples for outcome measurements at three different time points: basal, 6 weeks and 12 weeks of supplementation. Glycaemia and plasma inflammatory and metabolic markers will be measured, as well as the gut microbiota composition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, randomized, parallel group, placebo-controlled dietary intervention in prediabetic subjects.
| Arm | Type | Receives |
|---|---|---|
| Moringa | Experimental | Dietary Supplement: MoringaSix Moringa oleifera capsules (400 mg dry leaf powder /capsule) consumed daily during 12 weeks. Two capsules consumed with each of the three main meals. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSix placebo capsules containing microcrystalline cellulose consumed daily during 12 weeks. Two capsules consumed with each of the three main meals. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prediabetes: HbA1c between 5.7-6.4 % or fasting blood glucose between 100 - 125 mg/dl or impaired glucose tolerance (> 140 mg/dl and < 200 mg/dl two hours post oral challenge).
- No pharmacological treatment prescribed for glycemia control.
Key exclusion criteria (14 listed)
- Diabetes Mellitus
- Impaired renal function: < 60% Glomerular filtration
- Uncontrolled high blood pressure
- Previous cardiovascular events or coronary disease
- Autoimmune disease
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 |
|---|---|---|
| MoringaLeaves of Moringa oleifera from an organic Iberian peninsula cultivar. A single lot was prepared from the same crop. Leaves were dried and ground and encapsulated as a organic dietary supplement. No other changes in diet or physical activity were included although a general healthy lifestyle pattern was recommended. | Dietary supplement | Moringa |
| PlaceboPlacebo capsules were indistinguishable from the experimental capsules in material and color (opaque white). Same number of capsules were consumed as in the experimental arm and no other changes in diet or physical activity were included although a general healthy lifestyle pattern was recommended. | Dietary supplement | Placebo |
Primary outcome
Fasting Blood Glucose
Time frame: 12 weeks
Measured in serum samples from fasting blood withdrawn in a Sodium Fluoride vacutainer tube
Glycated hemoglobin (HbA1C)
Time frame: 12 weeks
Measured in fasting serum
1 secondary outcome
Conversion rate from prediabetes to normal
Time frame: 12 weeks
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 5 Feb 2021.
- Background: PubMed 32664295Nova E, Redondo-Useros N, Martinez-Garcia RM, Gomez-Martinez S, Diaz-Prieto LE, Marcos A. Potential of Moringa oleifera to Improve Glucose Control for the Prevention of Diabetes and Related Metabolic Alterations: A Systematic Review of Animal and Human Studies. Nutrients. 2020 Jul 10;12(7):2050. doi: 10.3390/nu12072050.
- Background: PubMed 31810205Vargas-Sanchez K, Garay-Jaramillo E, Gonzalez-Reyes RE. Effects of Moringa oleifera on Glycaemia and Insulin Levels: A Review of Animal and Human Studies. Nutrients. 2019 Dec 2;11(12):2907. doi: 10.3390/nu11122907.
- Individual participant dataSharing planned: Undecided. Although a specific plan has not been conceived yet, sharing research data is a good practice that the investigators would pursue at due time.
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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.
Esther NOVA, PhD principal investigator
National Research Council of Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moringa in people with PreDiabetes, run by National Research Council, Spain at 1 site in Spain.
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 2 inclusion and 14 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 5 Feb 2021. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Fasting Blood Glucose (time frame: 12 weeks). 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?
On the ClinicalTrials.gov record for NCT04734132, which also lists 2 linked publications.
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 5 Feb 2021.