Metabolic SyndromeMOINCT04314258
Effect of Moringa Oleifera Infusion on Health
A study testing Moringa oleifera tea in people with Metabolic Syndrome, run by University of Mauritius at 1 site in Mauritius.
Trial summary
The study aims at investigating the effects of the consumption of Moringa oleifera Lam leaves on biomedical markers of health among healthy individuals who are hyperglycaemic with a fasting blood glucose equal or greater than 5.5mmol/L. The main objectives are as follows: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Moringa oleifera tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteMauritius
- Study dates
- 10 Feb 2020to 31 Aug 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects with normal fasting plasma glucose levels
- Individuals with pre-diabetes condition newly diagnosed
- Individuals with dyslipidemia
- Type 2 Diabetes patients taking oral allopathic hypoglycemic agents
Who cannot join
- Pregnant women
- Smokers
- People with alcohol intake >2 standard drinks per day (in line with Bahorun et al. 2012)
- Patients with any complications of diabetes mellitus
- Patients on insulin therapy (in line with Leone et al. 2018)
- Patients with gastro-intestinal, hepatic, cardiovascular, renal or endocrine disorder (other than diabetes mellitus) which can interfere with the absorption, metabolism and excretion of Moringa leaves (in line with Bahorun et al. 2012)
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- Patients on medication for diseases other than diabetes
- Persons taking botanical extracts
- People currently on a diet (in line with Ahmad et al. 2018)
- People having food allergies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Study Investigating the Effect of Moringa Oleifera Infusion on Bioclinical Parameters of Health
The study aims at investigating the effects of the consumption of Moringa oleifera Lam leaves on biomedical markers of health among healthy individuals who are hyperglycaemic with a fasting blood glucose equal or greater than 5.5mmol/L.
The main objectives are as follows:
Read more
- To determine the effect of consuming 4 grams of Moringa oleifera Lam leaves infused in 200 ml of hot water twice daily on blood glucose level [BSc (Hons) Medical Science Student].
- To assess the effect of consuming 4 grams of Moringa oleifera Lam leaves infused in 200 ml of hot water twice daily on plasma lipids level [Master of Public Health Students].
- To compare the effect of the Moringa tea consumption on lipid profiles of both healthy and hyperglycemic participants [Master of Public Health Students].
- To evaluate the effects of Moringa oleifera Lam leaves on blood anti-oxidant status [BSc (Hons) Nutritional Sciences Student].
The research work will consist of (1) Experimental intervention: The experimental group will drink Moringa tea; (2) Survey questionnaire, (3) Anthropometric measurements, (4) Blood pressure determination and (5) Blood collections at 15-day intervals during 9 weeks. The blood tests to be performed are as follows: Glucose, HbA1C, Uric acid, C-Protein reactive, Lipid Profile (Total Cholesterol, HDL Cholesterol, Triglycerides), and blood antioxidants (superoxide dismutase, glutathione peroxidase, total blood anti-oxidant capacity).
Read the detailed description
Study population
120 participants to include 60 healthy individuals and 60 individuals who are hyperglycaemic with a fasting blood glucose equal or greater than 5.5mmol/L will be recruited by means of flyers, posters and mass email by the help of Staff Club of the UoM.
Experimental design
This research work will to be undertaken under the responsibility and coordination of the Applicant who is the Principal Investigator working with two Academic Supervisors for the supervision of the four student projects.
This randomized clinical study will consist of two parallel groups with a crossover design.
There will be two arms as follows for each group:
- Intervention group [drinking Moringa tea] and
- Control group [drinking plain water].
Computer-generated random numbers will be used for simple randomization of subjects to either the experimental or control (equal amount of water) groups. Half of the participants will be assigned to the experimental group and the other control (water) for the first 4 weeks during Phase 1.
The experimental group will be provided with Moringa tea bags and instructed to consume twice daily 2 tea bags (4 tea bags equivalent to 8 grams) of Moringa tea (Kanhye brand) infused in 200 ml of hot water (during 5 minutes) for a period of 4 weeks. The locally available Moringa tea with the international certification by ECOCERT France will be used in this study.
With the cross over design, there will be two phases for both healthy and hyperglycaemic groups with an interchange of the groups during Phase 1 and 2 as follows:
Four-week Phase 1 - Group A drinking Moringa tea v/s Group B drinking plain water One-week washout Four-week Phase 2 - Group A drinking plain water v/s Group B drinking Moringa tea
The duration of the clinical study will normally be nine weeks with possible extension of four weeks.
Outcome Measurements Baseline data collection Measurements of body weight and blood pressure will be performed. Anthropometric measurements will be taken for each subject: Weight will be measured using an electronic weighing machine, height will be measured using a stadiometer, waist circumference will be measured using a non-stretchable measuring tape. Blood pressure will be measured using a sphygmomanometer.
Blood samples will be drawn by Specialized Nursing Officers from right or left ante-cubital vein of participant after a 12-h overnight fast. Blood tests which will be performed are as follows: Glucose, Lipid profile [Triglycerides, Total Cholesterol and HDL Cholesterol levels (LDL Cholesterol being calculated)], Uric Acid, HbA1C, C-Reactive Protein (hs-CRP) and Blood anti-oxidants (superoxide dismutase, glutathione peroxidase, total blood anti-oxidant capacity).
Fortnight monitoring sessions All participants of the two groups will be monitored on a fortnight basis for body weight, height, waist circumference, blood pressure and specified blood tests. Food intake and physical exercise questionnaires will be collected from participants to determine confounding factors.
[The individual quantity of physical activity, in metabolic equivalent-minutes per week (MET-min/week), will be determined by using validated physical activity questionnaire].
Outcome Measurements Baseline data collection Measurements of body weight and blood pressure will be performed. Anthropometric measurements will be taken for each subject: Weight will be measured using an electronic weighing machine, height will be measured using a stadiometer, waist circumference will be measured using a non-stretchable measuring tape. Blood pressure will be measured using a sphygmomanometer.
Blood samples will be drawn by Specialized Nursing Officers from right or left ante-cubital vein of participant after a 12-h overnight fast. Blood tests which will be performed are as follows: Glucose, Lipid profile [Triglycerides, Total Cholesterol and HDL Cholesterol levels (LDL Cholesterol being calculated)], Uric Acid, HbA1C, C-Reactive Protein (hs-CRP) and Blood anti-oxidants (superoxide dismutase, glutathione peroxidase, total blood anti-oxidant capacity).
Fortnight monitoring sessions All participants of the two groups will be monitored on a fortnight basis for body weight, height, waist circumference, blood pressure and specified blood tests. Food intake and physical exercise questionnaires will be collected from participants to determine confounding factors.
[The individual quantity of physical activity, in metabolic equivalent-minutes per week (MET-min/week), will be determined by using validated physical activity questionnaire].
- Conditions
- Metabolic Syndrome
- Being tested
- Moringa oleifera tea
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa oleifera teaDietary supplement
4 grams of Moringa oleifera tea twice daily
| Study group | Role | What they receive |
|---|---|---|
| Drinking Moringa oleifera tea | Experimental | The experimental group will drink twice daily 2 tea bags of Moringa oleifera tea (Kanhye brand) infused in 200 ml of hot water (during 5 minutes) for a period of 4 weeks. The locally available Moringa tea with the international certification by ECOCERT France will be used in this study. Receives: Dietary Supplement: Moringa oleifera tea |
| Drinking plain water | No intervention | The control group will receive instructions to consume 200 ml of plain water twice daily for a period of 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose level
Change will be determined as the value at Day 29 with respect to Day 1 for Phase 1 (Four weeks) and for Phase 2 (four weeks)
Measured: Eight weeks
Change in Low-density Lipoprotein (LDL) Cholesterol level
Change will be determined as the value at Day 29 with respect to Day 1 for Phase 1 (Four weeks) and for Phase 2 (four weeks)
Measured: Eight weeks
Change in Triglyceride level
Change will be determined as the value at Day 29 with respect to Day 1 for Phase 1 (Four weeks) and for Phase 2 (four weeks)
Measured: Eight weeks
Secondary outcomes (1)
Change in levels of blood anti-oxidants
Levels of blood anti-oxidants (superoxide dismutase, glutathione peroxidase, total blood anti-oxidant capacity) will be monitored every fortnight during the 8-week clinical trial. C-Reactive Protein will also be measured.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start10 Feb 2020
- Primary completion30 Apr 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This randomized clinical study will consist of two parallel groups with a crossover design. There will be two arms as follows: 1. Intervention group \[Drinking Moringa tea\] 2. Control group \[Drinking plain water\]. Computer-generated random numbers will be used for simple randomization of subjects to either the experimental or control group. With the cross over design, there will be two phases with an interchange of the groups during Phase 1 and 2 as follows: Four-week Phase 1 - Group A drinking Moringa tea v/s Group B drinking plain water One-week washout Four-week Phase 2 - Group A drinking plain water v/s Group B drinking Moringa tea
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mauritius
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MChanSun, University of Mauritius
- Investigators
- Marie CHAN SUN, PhD, Principal investigator, University of MauritiusVidushi NEERGHEEN, PhD, Study director, University of MauritiusAbha JODHEEA-JUTTON, MD, Study chair, University of Mauritius
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314258
- Sponsor's protocol ID
- UOM002
- Acronym
- MOI
- Status last verified
- Mar 2020
- First submitted
- 18 Feb 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.
Publications
Bahorun T, Luximon-Ramma A, Neergheen-Bhujun VS, Gunness TK, Googoolye K, Auger C, Crozier A, Aruoma OI. The effect of black tea on risk factors of cardiovascular disease in a normal population. Prev Med. 2012 May;54 Suppl:S98-102. doi: 10.1016/j.ypmed.2011.12.009. Epub 2011 Dec 16.
PubMed 22198621Leone A, Bertoli S, Di Lello S, Bassoli A, Ravasenghi S, Borgonovo G, Forlani F, Battezzati A. Effect of Moringa oleifera Leaf Powder on Postprandial Blood Glucose Response: In Vivo Study on Saharawi People Living in Refugee Camps. Nutrients. 2018 Oct 12;10(10):1494. doi: 10.3390/nu10101494.
PubMed 30322091Ahmad J, Khan I, Johnson SK, Alam I, Din ZU. Effect of Incorporating Stevia and Moringa in Cookies on Postprandial Glycemia, Appetite, Palatability, and Gastrointestinal Well-Being. J Am Coll Nutr. 2018 Feb;37(2):133-139. doi: 10.1080/07315724.2017.1372821. Epub 2017 Dec 22.
PubMed 29272206Kumari, D. J. (2010) 'Hypoglycaemic Effect of Moringa Oleifera and Azadirachta Indica in Type 2 Diabetes Mellitus', The Bioscan, 5(2), p. 4.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study Investigating the Effect of Moringa Oleifera Infusion on Bioclinical Parameters of Health
- ClinicalTrials.gov ID
- NCT04314258
- Acronym / sponsor ID
- MOI / UOM002
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- University of MauritiusUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 19 Mar 2020 (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 study aims at investigating the effects of the consumption of Moringa oleifera Lam leaves on biomedical markers of health among healthy individuals who are hyperglycaemic with a fasting blood glucose equal or greater than 5.5mmol/L.
The main objectives are as follows:
- To determine the effect of consuming 4 grams of Moringa oleifera Lam leaves infused in 200 ml of hot water twice daily on blood glucose level [BSc (Hons) Medical Science Student].
- To assess the effect of consuming 4 grams of Moringa oleifera Lam leaves infused in 200 ml of hot water twice daily on plasma lipids level [Master of Public Health Students].
- To compare the effect of the Moringa tea consumption on lipid profiles of both healthy and hyperglycemic participants [Master of Public Health Students].
- To evaluate the effects of Moringa oleifera Lam leaves on blood anti-oxidant status [BSc (Hons) Nutritional Sciences Student].
The research work will consist of (1) Experimental intervention: The experimental group will drink Moringa tea; (2) Survey questionnaire, (3) Anthropometric measurements, (4) Blood pressure determination and (5) Blood collections at 15-day intervals during 9 weeks. The blood tests to be performed are as follows: Glucose, HbA1C, Uric acid, C-Protein reactive, Lipid Profile (Total Cholesterol, HDL Cholesterol, Triglycerides), and blood antioxidants (superoxide dismutase, glutathione peroxidase, total blood anti-oxidant capacity).
Detailed description
Study population
120 participants to include 60 healthy individuals and 60 individuals who are hyperglycaemic with a fasting blood glucose equal or greater than 5.5mmol/L will be recruited by means of flyers, posters and mass email by the help of Staff Club of the UoM.
Experimental design
This research work will to be undertaken under the responsibility and coordination of the Applicant who is the Principal Investigator working with two Academic Supervisors for the supervision of the four student projects.
This randomized clinical study will consist of two parallel groups with a crossover design.
There will be two arms as follows for each group:
- Intervention group [drinking Moringa tea] and
- Control group [drinking plain water].
Computer-generated random numbers will be used for simple randomization of subjects to either the experimental or control (equal amount of water) groups. Half of the participants will be assigned to the experimental group and the other control (water) for the first 4 weeks during Phase 1.
The experimental group will be provided with Moringa tea bags and instructed to consume twice daily 2 tea bags (4 tea bags equivalent to 8 grams) of Moringa tea (Kanhye brand) infused in 200 ml of hot water (during 5 minutes) for a period of 4 weeks. The locally available Moringa tea with the international certification by ECOCERT France will be used in this study.
With the cross over design, there will be two phases for both healthy and hyperglycaemic groups with an interchange of the groups during Phase 1 and 2 as follows:
Four-week Phase 1 - Group A drinking Moringa tea v/s Group B drinking plain water One-week washout Four-week Phase 2 - Group A drinking plain water v/s Group B drinking Moringa tea
The duration of the clinical study will normally be nine weeks with possible extension of four weeks.
Outcome Measurements Baseline data collection Measurements of body weight and blood pressure will be performed. Anthropometric measurements will be taken for each subject: Weight will be measured using an electronic weighing machine, height will be measured using a stadiometer, waist circumference will be measured using a non-stretchable measuring tape. Blood pressure will be measured using a sphygmomanometer.
Blood samples will be drawn by Specialized Nursing Officers from right or left ante-cubital vein of participant after a 12-h overnight fast. Blood tests which will be performed are as follows: Glucose, Lipid profile [Triglycerides, Total Cholesterol and HDL Cholesterol levels (LDL Cholesterol being calculated)], Uric Acid, HbA1C, C-Reactive Protein (hs-CRP) and Blood anti-oxidants (superoxide dismutase, glutathione peroxidase, total blood anti-oxidant capacity).
Fortnight monitoring sessions All participants of the two groups will be monitored on a fortnight basis for body weight, height, waist circumference, blood pressure and specified blood tests. Food intake and physical exercise questionnaires will be collected from participants to determine confounding factors.
[The individual quantity of physical activity, in metabolic equivalent-minutes per week (MET-min/week), will be determined by using validated physical activity questionnaire].
Outcome Measurements Baseline data collection Measurements of body weight and blood pressure will be performed. Anthropometric measurements will be taken for each subject: Weight will be measured using an electronic weighing machine, height will be measured using a stadiometer, waist circumference will be measured using a non-stretchable measuring tape. Blood pressure will be measured using a sphygmomanometer.
Blood samples will be drawn by Specialized Nursing Officers from right or left ante-cubital vein of participant after a 12-h overnight fast. Blood tests which will be performed are as follows: Glucose, Lipid profile [Triglycerides, Total Cholesterol and HDL Cholesterol levels (LDL Cholesterol being calculated)], Uric Acid, HbA1C, C-Reactive Protein (hs-CRP) and Blood anti-oxidants (superoxide dismutase, glutathione peroxidase, total blood anti-oxidant capacity).
Fortnight monitoring sessions All participants of the two groups will be monitored on a fortnight basis for body weight, height, waist circumference, blood pressure and specified blood tests. Food intake and physical exercise questionnaires will be collected from participants to determine confounding factors.
[The individual quantity of physical activity, in metabolic equivalent-minutes per week (MET-min/week), will be determined by using validated physical activity questionnaire].
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized clinical study will consist of two parallel groups with a crossover design. There will be two arms as follows: 1. Intervention group [Drinking Moringa tea] 2. Control group [Drinking plain water]. Computer-generated random numbers will be used for simple randomization of subjects to either the experimental or control group. With the cross over design, there will be two phases with an interchange of the groups during Phase 1 and 2 as follows: Four-week Phase 1 - Group A drinking Moringa tea v/s Group B drinking plain water One-week washout Four-week Phase 2 - Group A drinking plain water v/s Group B drinking Moringa tea
| Arm | Type | Receives |
|---|---|---|
| Drinking Moringa oleifera tea | Experimental | Dietary Supplement: Moringa oleifera teaThe experimental group will drink twice daily 2 tea bags of Moringa oleifera tea (Kanhye brand) infused in 200 ml of hot water (during 5 minutes) for a period of 4 weeks. The locally available Moringa tea with the international certification by ECOCERT France will be used in this study. |
| Drinking plain water | No intervention | –The control group will receive instructions to consume 200 ml of plain water twice daily for a period of 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects with normal fasting plasma glucose levels
- Individuals with pre-diabetes condition newly diagnosed
- Individuals with dyslipidemia
- Type 2 Diabetes patients taking oral allopathic hypoglycemic agents
Key exclusion criteria (10 listed)
- Pregnant women
- Smokers
- People with alcohol intake >2 standard drinks per day (in line with Bahorun et al. 2012)
- Patients with any complications of diabetes mellitus
- Patients on insulin therapy (in line with Leone et al. 2018)
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 |
|---|---|---|
| Moringa oleifera tea4 grams of Moringa oleifera tea twice daily | Dietary supplement | Drinking Moringa oleifera tea |
Primary outcome
Change in blood glucose level
Time frame: Eight weeks
Change will be determined as the value at Day 29 with respect to Day 1 for Phase 1 (Four weeks) and for Phase 2 (four weeks)
Change in Low-density Lipoprotein (LDL) Cholesterol level
Time frame: Eight weeks
Change will be determined as the value at Day 29 with respect to Day 1 for Phase 1 (Four weeks) and for Phase 2 (four weeks)
Change in Triglyceride level
Time frame: Eight weeks
Change will be determined as the value at Day 29 with respect to Day 1 for Phase 1 (Four weeks) and for Phase 2 (four weeks)
1 secondary outcome
Change in levels of blood anti-oxidants
Time frame: Eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Background: PubMed 22198621Bahorun T, Luximon-Ramma A, Neergheen-Bhujun VS, Gunness TK, Googoolye K, Auger C, Crozier A, Aruoma OI. The effect of black tea on risk factors of cardiovascular disease in a normal population. Prev Med. 2012 May;54 Suppl:S98-102. doi: 10.1016/j.ypmed.2011.12.009. Epub 2011 Dec 16.
- Background: PubMed 30322091Leone A, Bertoli S, Di Lello S, Bassoli A, Ravasenghi S, Borgonovo G, Forlani F, Battezzati A. Effect of Moringa oleifera Leaf Powder on Postprandial Blood Glucose Response: In Vivo Study on Saharawi People Living in Refugee Camps. Nutrients. 2018 Oct 12;10(10):1494. doi: 10.3390/nu10101494.
- Background: PubMed 29272206Ahmad J, Khan I, Johnson SK, Alam I, Din ZU. Effect of Incorporating Stevia and Moringa in Cookies on Postprandial Glycemia, Appetite, Palatability, and Gastrointestinal Well-Being. J Am Coll Nutr. 2018 Feb;37(2):133-139. doi: 10.1080/07315724.2017.1372821. Epub 2017 Dec 22.
- BackgroundKumari, D. J. (2010) 'Hypoglycaemic Effect of Moringa Oleifera and Azadirachta Indica in Type 2 Diabetes Mellitus', The Bioscan, 5(2), p. 4.
- Individual participant dataSharing planned: Yes. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.
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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.
Marie CHAN SUN, PhD principal investigator
University of Mauritius
Vidushi NEERGHEEN, PhD study director
University of Mauritius
Abha JODHEEA-JUTTON, MD study chair
University of Mauritius
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 oleifera tea in people with Metabolic Syndrome, run by University of Mauritius at 1 site in Mauritius.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Mar 2020. 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 Mauritius. 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?
Results are not available in the source record.
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?
Change in blood glucose level (time frame: Eight weeks). The study lists 3 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 NCT04314258, which also lists 4 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 19 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.