Metabolic SyndromePhase 2/3NCT03633630
Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
A Phase 2/3 study testing Amla in people with Metabolic Syndrome, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Amla has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Amla has an excellent potential for the prevention and treatment of metabolic syndrome. Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Amla
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2019to 30 Mar 2022
- Phase
- Phase 2/3
- 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 30 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed Metabolic Syndrome according to the IDF criteria:
- - - Waist circumference: ≥80 cm (women) ≥90 cm (men), plus two or more of the following:
- - - Fasting glucose ≥ 100 mg/dL to <126 mg/dL.
- - - Triglycerides ≥150 mg/dL to <499 mg/dL
- - - HDL-C: Men ≤40 mg/dL, women ≤50 mg/dL
- - - Systolic blood pressure ≥130 to <140 mmHg
Show all 9Show fewer
- - - Diastolic blood pressure ≥85 to <89 mmHg
- Body Mass Index between 25 and 34.9 kg/m²
- No pharmacological treatment for Metabolic Syndrome
Who cannot join
- Pregnancy or breast-feeding
- Known allergy to Amla or placebo
- History of hepatic, kidney or thyroid disease
- Drugs or supplements consumption with proven properties that modify the behavior of the Metabolic Syndrome
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Institute of Experimental and Clinical Therapeutics
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of Amla Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion.
Amla has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Amla has an excellent potential for the prevention and treatment of metabolic syndrome.
Read the detailed description
A randomized, double-blind, placebo-controlled clinical trial will be conducted in 28 patients, 30-59 years old, with diagnosis of Metabolic Syndrome according with modified International Diabetes Federation criteria. Patients will be randomly assigned to receive Amla (500mg) or homologated placebo orally twice daily, for 90 days. Before and after the intervention, the components of Metabolic Syndrome will be evaluated, waist circumference, blood pressure, levels of fasting glucose, triglycerides, cholesterol high density lipoprotein (C-HDL), total insulin secretion (Insulinogenic index), first phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
- Conditions
- Metabolic Syndrome
- Being tested
- Amla, Placebo
- Keywords
- Amla, Emblica officinalis, Metabolic Syndrome, Insulin Secretion, Insulin Sensitivity
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlaDrug
Also called Emblica Officinalis
Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
PlaceboDrug
Also called Calcined Magnesia
Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
| Study group | Role | What they receive |
|---|---|---|
| Amla (Emblica Officinalis) | Experimental | 1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days. Receives: Drug: Amla |
| Placebo | Placebo comparator | 1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist Circumference (WC)
The WC will be evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest. The value will be expressed in centimeters.
Measured: 90 days
Triglycerides (TGs)
The blood sample for determining of TGs, will be taken after an overnight fast and with a spectrophotometry method. The value will be expressed on mmol/L.
Measured: 90 days
High-density Lipoprotein Cholesterol (HDL-C)
The blood sample for determining of HDL-C, will be taken after an overnight fast with a colorimetric method. The value will be expressed on mmol/L.
Measured: 90 days
Fasting Plasma Glucose (FPG)
The blood sample for determining of FPG, will be taken after an overnight fast and with a spectrophotometry method. The value will be expressed on mmol/L.
Measured: 90 days
Systolic Blood Pressure (SBP)
The SBP will be evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures will be considered as the value of SBP. The value will be expressed on mmHg.
Measured: 90 days
Diastolic Blood Pressure (DBP)
The DBP will be evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures will be considered as the value of DBP. The value will be expressed on mmHg.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Apr 2019
- Primary completion30 Oct 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esperanza Martínez-Abundis, University of Guadalajara
- Investigators
- Esperanza Martínez-Abundis, PhD, Principal investigator, Institute of Experimental and Clinical Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633630
- Sponsor's protocol ID
- Amla MS
- Status last verified
- Nov 2022
- First submitted
- 14 Aug 2018
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Athyros VG, Mikhailidis DP. High incidence of metabolic syndrome further increases cardiovascular risk in patients with type 2 diabetes. Implications for everyday practice. J Diabetes Complications. 2016 Jan-Feb;30(1):9-11. doi: 10.1016/j.jdiacomp.2015.07.012. Epub 2015 Jul 17. No abstract available.
PubMed 26275865Samson SL, Garber AJ. Metabolic syndrome. Endocrinol Metab Clin North Am. 2014 Mar;43(1):1-23. doi: 10.1016/j.ecl.2013.09.009.
PubMed 24582089Martinez-Abundis E, Mendez-Del Villar M, Perez-Rubio KG, Zuniga LY, Cortez-Navarrete M, Ramirez-Rodriguez A, Gonzalez-Ortiz M. Novel nutraceutic therapies for the treatment of metabolic syndrome. World J Diabetes. 2016 Apr 10;7(7):142-52. doi: 10.4239/wjd.v7.i7.142.
PubMed 27076875Variya BC, Bakrania AK, Patel SS. Emblica officinalis (Amla): A review for its phytochemistry, ethnomedicinal uses and medicinal potentials with respect to molecular mechanisms. Pharmacol Res. 2016 Sep;111:180-200. doi: 10.1016/j.phrs.2016.06.013. Epub 2016 Jun 15.
PubMed 27320046Akhtar MS, Ramzan A, Ali A, Ahmad M. Effect of Amla fruit (Emblica officinalis Gaertn.) on blood glucose and lipid profile of normal subjects and type 2 diabetic patients. Int J Food Sci Nutr. 2011 Sep;62(6):609-16. doi: 10.3109/09637486.2011.560565. Epub 2011 Apr 18.
PubMed 21495900Cerezo C, Segura J, Praga M, Ruilope LM. Guidelines updates in the treatment of obesity or metabolic syndrome and hypertension. Curr Hypertens Rep. 2013 Jun;15(3):196-203. doi: 10.1007/s11906-013-0337-4.
PubMed 23519746Perez-Rubio KG, Gonzalez-Ortiz M, Martinez-Abundis E, Robles-Cervantes JA, Espinel-Bermudez MC. Effect of berberine administration on metabolic syndrome, insulin sensitivity, and insulin secretion. Metab Syndr Relat Disord. 2013 Oct;11(5):366-9. doi: 10.1089/met.2012.0183. Epub 2013 Jun 28.
PubMed 23808999O'Neill S, O'Driscoll L. Metabolic syndrome: a closer look at the growing epidemic and its associated pathologies. Obes Rev. 2015 Jan;16(1):1-12. doi: 10.1111/obr.12229. Epub 2014 Nov 18.
PubMed 25407540Mendez-Del Villar M, Gonzalez-Ortiz M, Martinez-Abundis E, Perez-Rubio KG, Cortez-Navarrete M. Effect of Irvingia gabonensis on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion. J Med Food. 2018 Jun;21(6):568-574. doi: 10.1089/jmf.2017.0092. Epub 2018 Jan 16.
PubMed 29336718Ruilope LM, Nunes Filho ACB, Nadruz W Jr, Rodriguez Rosales FF, Verdejo-Paris J. Obesity and hypertension in Latin America: Current perspectives. Hipertens Riesgo Vasc. 2018 Apr-Jun;35(2):70-76. doi: 10.1016/j.hipert.2017.12.004. Epub 2018 Feb 1.
PubMed 29361428Grundy SM. Pre-diabetes, metabolic syndrome, and cardiovascular risk. J Am Coll Cardiol. 2012 Feb 14;59(7):635-43. doi: 10.1016/j.jacc.2011.08.080.
PubMed 22322078Harano Y, Suzuki M, Koyama Y, Kanda M, Yasuda S, Suzuki K, Takamizawa I. Multifactorial insulin resistance and clinical impact in hypertension and cardiovascular diseases. J Diabetes Complications. 2002 Jan-Feb;16(1):19-23. doi: 10.1016/s1056-8727(01)00192-1.
PubMed 11872361Lim S, Eckel RH. Pharmacological treatment and therapeutic perspectives of metabolic syndrome. Rev Endocr Metab Disord. 2014 Dec;15(4):329-41. doi: 10.1007/s11154-014-9298-4.
PubMed 25342235Park SE, Park CY, Sweeney G. Biomarkers of insulin sensitivity and insulin resistance: Past, present and future. Crit Rev Clin Lab Sci. 2015;52(4):180-90. doi: 10.3109/10408363.2015.1023429. Epub 2015 Jun 4.
PubMed 26042993Gutch M, Kumar S, Razi SM, Gupta KK, Gupta A. Assessment of insulin sensitivity/resistance. Indian J Endocrinol Metab. 2015 Jan-Feb;19(1):160-4. doi: 10.4103/2230-8210.146874.
PubMed 25593845
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amla Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion.
- ClinicalTrials.gov ID
- NCT03633630
- Acronym / sponsor ID
- Amla MS
- Conditions
- Metabolic Syndrome
- Keywords
- Amla, Emblica officinalis, Metabolic Syndrome, Insulin Secretion, Insulin Sensitivity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 16 Aug 2018 (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.
Amla has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Amla has an excellent potential for the prevention and treatment of metabolic syndrome.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial will be conducted in 28 patients, 30-59 years old, with diagnosis of Metabolic Syndrome according with modified International Diabetes Federation criteria. Patients will be randomly assigned to receive Amla (500mg) or homologated placebo orally twice daily, for 90 days. Before and after the intervention, the components of Metabolic Syndrome will be evaluated, waist circumference, blood pressure, levels of fasting glucose, triglycerides, cholesterol high density lipoprotein (C-HDL), total insulin secretion (Insulinogenic index), first phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amla (Emblica Officinalis) | Experimental | Drug: Amla1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days. |
| Placebo | Placebo comparator | Drug: Placebo1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Diagnosed Metabolic Syndrome according to the IDF criteria:
- - - Waist circumference: ≥80 cm (women) ≥90 cm (men), plus two or more of the following:
- - - Fasting glucose ≥ 100 mg/dL to <126 mg/dL.
- - - Triglycerides ≥150 mg/dL to <499 mg/dL
- - - HDL-C: Men ≤40 mg/dL, women ≤50 mg/dL
Key exclusion criteria (4 listed)
- Pregnancy or breast-feeding
- Known allergy to Amla or placebo
- History of hepatic, kidney or thyroid disease
- Drugs or supplements consumption with proven properties that modify the behavior of the Metabolic Syndrome
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 |
|---|---|---|
| AmlaAlso: Emblica OfficinalisCapsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days | Drug | Amla (Emblica Officinalis) |
| PlaceboAlso: Calcined MagnesiaCapsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days | Drug | Placebo |
Primary outcome
Waist Circumference (WC)
Time frame: 90 days
The WC will be evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest. The value will be expressed in centimeters.
Triglycerides (TGs)
Time frame: 90 days
The blood sample for determining of TGs, will be taken after an overnight fast and with a spectrophotometry method. The value will be expressed on mmol/L.
High-density Lipoprotein Cholesterol (HDL-C)
Time frame: 90 days
The blood sample for determining of HDL-C, will be taken after an overnight fast with a colorimetric method. The value will be expressed on mmol/L.
Fasting Plasma Glucose (FPG)
Time frame: 90 days
The blood sample for determining of FPG, will be taken after an overnight fast and with a spectrophotometry method. The value will be expressed on mmol/L.
Systolic Blood Pressure (SBP)
Time frame: 90 days
The SBP will be evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures will be considered as the value of SBP. The value will be expressed on mmHg.
Diastolic Blood Pressure (DBP)
Time frame: 90 days
The DBP will be evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures will be considered as the value of DBP. The value will be expressed on mmHg.
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 8 Nov 2022.
- Background: PubMed 26275865Athyros VG, Mikhailidis DP. High incidence of metabolic syndrome further increases cardiovascular risk in patients with type 2 diabetes. Implications for everyday practice. J Diabetes Complications. 2016 Jan-Feb;30(1):9-11. doi: 10.1016/j.jdiacomp.2015.07.012. Epub 2015 Jul 17. No abstract available.
- Background: PubMed 24582089Samson SL, Garber AJ. Metabolic syndrome. Endocrinol Metab Clin North Am. 2014 Mar;43(1):1-23. doi: 10.1016/j.ecl.2013.09.009.
- Background: PubMed 27076875Martinez-Abundis E, Mendez-Del Villar M, Perez-Rubio KG, Zuniga LY, Cortez-Navarrete M, Ramirez-Rodriguez A, Gonzalez-Ortiz M. Novel nutraceutic therapies for the treatment of metabolic syndrome. World J Diabetes. 2016 Apr 10;7(7):142-52. doi: 10.4239/wjd.v7.i7.142.
- Background: PubMed 27320046Variya BC, Bakrania AK, Patel SS. Emblica officinalis (Amla): A review for its phytochemistry, ethnomedicinal uses and medicinal potentials with respect to molecular mechanisms. Pharmacol Res. 2016 Sep;111:180-200. doi: 10.1016/j.phrs.2016.06.013. Epub 2016 Jun 15.
- Background: PubMed 21495900Akhtar MS, Ramzan A, Ali A, Ahmad M. Effect of Amla fruit (Emblica officinalis Gaertn.) on blood glucose and lipid profile of normal subjects and type 2 diabetic patients. Int J Food Sci Nutr. 2011 Sep;62(6):609-16. doi: 10.3109/09637486.2011.560565. Epub 2011 Apr 18.
- Background: PubMed 23519746Cerezo C, Segura J, Praga M, Ruilope LM. Guidelines updates in the treatment of obesity or metabolic syndrome and hypertension. Curr Hypertens Rep. 2013 Jun;15(3):196-203. doi: 10.1007/s11906-013-0337-4.
- Background: PubMed 23808999Perez-Rubio KG, Gonzalez-Ortiz M, Martinez-Abundis E, Robles-Cervantes JA, Espinel-Bermudez MC. Effect of berberine administration on metabolic syndrome, insulin sensitivity, and insulin secretion. Metab Syndr Relat Disord. 2013 Oct;11(5):366-9. doi: 10.1089/met.2012.0183. Epub 2013 Jun 28.
- Background: PubMed 25407540O'Neill S, O'Driscoll L. Metabolic syndrome: a closer look at the growing epidemic and its associated pathologies. Obes Rev. 2015 Jan;16(1):1-12. doi: 10.1111/obr.12229. Epub 2014 Nov 18.
- Background: PubMed 29336718Mendez-Del Villar M, Gonzalez-Ortiz M, Martinez-Abundis E, Perez-Rubio KG, Cortez-Navarrete M. Effect of Irvingia gabonensis on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion. J Med Food. 2018 Jun;21(6):568-574. doi: 10.1089/jmf.2017.0092. Epub 2018 Jan 16.
- Background: PubMed 29361428Ruilope LM, Nunes Filho ACB, Nadruz W Jr, Rodriguez Rosales FF, Verdejo-Paris J. Obesity and hypertension in Latin America: Current perspectives. Hipertens Riesgo Vasc. 2018 Apr-Jun;35(2):70-76. doi: 10.1016/j.hipert.2017.12.004. Epub 2018 Feb 1.
- Background: PubMed 22322078Grundy SM. Pre-diabetes, metabolic syndrome, and cardiovascular risk. J Am Coll Cardiol. 2012 Feb 14;59(7):635-43. doi: 10.1016/j.jacc.2011.08.080.
- Background: PubMed 11872361Harano Y, Suzuki M, Koyama Y, Kanda M, Yasuda S, Suzuki K, Takamizawa I. Multifactorial insulin resistance and clinical impact in hypertension and cardiovascular diseases. J Diabetes Complications. 2002 Jan-Feb;16(1):19-23. doi: 10.1016/s1056-8727(01)00192-1.
- Individual participant dataSharing planned: No
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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.
Esperanza Martínez-Abundis, PhD principal investigator
Institute of Experimental and Clinical Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amla in people with Metabolic Syndrome, run by University of Guadalajara at 1 site in Mexico.
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 9 inclusion and 4 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 8 Nov 2022. 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 Mexico. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Waist Circumference (WC) (time frame: 90 days). The study lists 6 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 NCT03633630, which also lists 30 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 8 Nov 2022.