Metabolic Syndrome XPhase 2NCT02767869

Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity

A Phase 2 study testing Banaba in people with Metabolic Syndrome X, run by University of Guadalajara at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease. Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin secretion. Read more about this study

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Metabolic Syndrome X
What is being tested?: Banaba
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteMexico
Study dates: Jan 2015to Feb 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients both sexes,
Age between 30 and 60 years,
Metabolic Syndrome according to the IDF criteria
Waist circumference
Man ≥90 cm
Woman ≥80 cm

Show all 14Show fewer

And two of the following criteria:
High density lipoprotein
Man ≤40 mg/dL
Woman ≤50 mg/dL
Fasting glucose ≥100 mg/dL
Triglycerides ≥150 mg/dL
Blood pressure ≥130/85 mmHg
Informed consent signed

Who cannot join

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Hypersensibility to resveratrol
Physical impossibility for taking pills
Known uncontrolled renal, hepatic, heart or thyroid diseased
Previous treatment for the metabolic syndrome components

Show all 12Show fewer

Body Mass Index ≥39.9 kg/m2
Fasting glucose ≥126 mg/dL
Triglycerides ≥500 mg/dL
Total cholesterol ≥240 mg/dL
Low density lipoprotein (c-LDL) ≥190 mg/dL
Blood Pressure ≥140/90 mmHg

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 45037

Other trials in Mexico

About this study

The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.

Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin secretion.

The investigators hypothesis was that the the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

Read the detailed description

A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, and lipid profile were evaluated after a 75 g of dextrose load.

12 received Banaba, 500 mg, two times per day (1000 mg) before meals during 3 months.

The remaining 12 patients received placebo with the same prescription.

Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.

Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.

Conditions: Metabolic Syndrome X
Being tested: Banaba, placebo
Keywords: Metabolic syndrome, central obesity, Banaba, insulin secretion, insulin sensitivity
Medical subject headings: Metabolic Syndrome, Obesity, Abdominal, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BanabaDrug
Also called Lagerstroemia speciosa
Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
placeboDrug
Also called calcined magnesia
Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg

Study groups in NCT02767869
Study group	Role	What they receive
Banaba	Experimental	Banaba capsules, 500mg, two times per day before meals during 90 days Receives: Drug: Banaba
Placebo	Placebo comparator	Calcined magnesia capsules, 500mg, two times per day before meals during 90 days Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Triglyceride Levels at Week 12
The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.
Measured: Week 12
High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12
The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques.
Measured: Week 12
Fasting Glucose Levels at Week 12
The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Measured: Week 12
Systolic Blood Pressure at Week 12.
The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12
Measured: Week 12
First Phase of Insulin Secretion at Week 12
Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.
First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12.
Measured: Week 12
Total Insulin Secretion at Week 12.
Measure Description: The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.
Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.
Measured: Week 12
Total Insulin Sensitivity at Week 12
Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity at week 12.
Measured: Week 12
Waist Circumference at Week 12
Waist circumference will be evaluated at baseline and at week 12 with a flexible tape
Measured: Week 12
Diastolic Blood Pressure at Week 12
The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12
Measured: Week 12

Secondary outcomes (4)

Weight at Week 12
The weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12
Measured: Week 12
Body Mass Index at Week 12
The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12
Measured: Week 12
Total Cholesterol at Week 12
The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12
Measured: Week 12
Low-density Lipoprotein-cholesterol (LDL-C) at Week 12
The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Feb 2017

First posted10 May 2016 (estimated)
Study startJan 2015
Primary completionDec 2016
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metabolic Syndrome XStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02767869
Sponsor's protocol ID: BANABA-MS
Status last verified: Dec 2020
First submitted: 6 May 2016
Last updated: 14 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lopez-Murillo LD, Gonzalez-Ortiz M, Martinez-Abundis E, Cortez-Navarrete M, Perez-Rubio KG. Effect of Banaba (Lagerstroemia speciosa) on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion. J Med Food. 2022 Feb;25(2):177-182. doi: 10.1089/jmf.2021.0039. Epub 2021 Nov 2.
PubMed 34726501

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome X trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
ClinicalTrials.gov ID: NCT02767869
Acronym / sponsor ID: BANABA-MS
Conditions: Metabolic Syndrome X
Keywords: Metabolic syndrome, central obesity, Banaba, insulin secretion, insulin sensitivity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of GuadalajaraUniversity, hospital or other
Study start: Jan 2015
Primary completion: Dec 2016 (actual)
Study completion: Feb 2017 (actual)
First posted: 10 May 2016 (estimated)
Results: Posted 20 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.

Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin secretion.

The investigators hypothesis was that the the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

Detailed description

12 received Banaba, 500 mg, two times per day (1000 mg) before meals during 3 months.

The remaining 12 patients received placebo with the same prescription.

This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Banaba	Experimental	Drug: BanabaBanaba capsules, 500mg, two times per day before meals during 90 days
Placebo	Placebo comparator	Drug: placeboCalcined magnesia capsules, 500mg, two times per day before meals during 90 days

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Patients both sexes,
Age between 30 and 60 years,
Metabolic Syndrome according to the IDF criteria
Waist circumference
Man ≥90 cm

Key exclusion criteria (12 listed)

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Hypersensibility to resveratrol
Physical impossibility for taking pills
Known uncontrolled renal, hepatic, heart or thyroid diseased

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
BanabaAlso: Lagerstroemia speciosaBanaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.	Drug	Banaba
placeboAlso: calcined magnesiaCalcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg	Drug	Placebo

Primary outcome

Triglyceride Levels at Week 12
Time frame: Week 12
The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.
High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12
Time frame: Week 12
The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques.
Fasting Glucose Levels at Week 12
Time frame: Week 12
The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Systolic Blood Pressure at Week 12.
Time frame: Week 12
The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12
First Phase of Insulin Secretion at Week 12
Time frame: Week 12
Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12.
Total Insulin Secretion at Week 12.
Time frame: Week 12
Measure Description: The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.
Total Insulin Sensitivity at Week 12
Time frame: Week 12
Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity at week 12.
Waist Circumference at Week 12
Time frame: Week 12
Waist circumference will be evaluated at baseline and at week 12 with a flexible tape
Diastolic Blood Pressure at Week 12
Time frame: Week 12
The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12

4 secondary outcomes

Weight at Week 12
Time frame: Week 12
Body Mass Index at Week 12
Time frame: Week 12
Total Cholesterol at Week 12
Time frame: Week 12
Low-density Lipoprotein-cholesterol (LDL-C) at Week 12
Time frame: Week 12

Results and safety

Results posted to the registry on 20 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Banaba	12	12
Placebo	12	12

Primary outcome: Triglyceride Levels at Week 12

Time frame: Week 12. Mean (Standard Deviation). Unit: mg/dL

Measure	Banaba n = 12	Placebo n = 12
Value	148.0 (43.0)	199.9 (101.9)

Banaba vs Placebo: p = 0.021, Wilcoxon (Mann-Whitney)

Population analysed: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Primary outcome: High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12

Time frame: Week 12. Mean (Standard Deviation). Unit: mg/dL

Measure	Banaba n = 12	Placebo n = 12
Value	56.4 (11.2)	58.4 (16)

Banaba vs Placebo: p = 0.530, Wilcoxon (Mann-Whitney)

Population analysed: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Primary outcome: Fasting Glucose Levels at Week 12

Time frame: Week 12. Mean (Standard Deviation). Unit: mg/dL

Measure	Banaba n = 12	Placebo n = 12
Value	103.2 (7.4)	104.2 (8.9)

Banaba vs Placebo: p = 0.034, Wilcoxon (Mann-Whitney)

Population analysed: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Primary outcome: Systolic Blood Pressure at Week 12.

Time frame: Week 12. Mean (Standard Deviation). Unit: mmHg

Measure	Banaba n = 12	Placebo n = 12
Value	116.3 (9.8)	122.6 (13.1)

Banaba vs Placebo: p = 0.050, Wilcoxon (Mann-Whitney)

Population analysed: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected throughout the 12-week study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Banaba	0 of 12 (0%)	12 of 12 (100%)	0 of 12
Placebo	0 of 12 (0%)	9 of 12 (75%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34726501Lopez-Murillo LD, Gonzalez-Ortiz M, Martinez-Abundis E, Cortez-Navarrete M, Perez-Rubio KG. Effect of Banaba (Lagerstroemia speciosa) on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion. J Med Food. 2022 Feb;25(2):177-182. doi: 10.1089/jmf.2021.0039. Epub 2021 Nov 2.

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RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
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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.

MANUEL GONZALEZ, PhD principal investigator

University of Guadalajara

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Banaba in people with Metabolic Syndrome X, 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 14 inclusion and 12 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 14 Jan 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 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Triglyceride Levels at Week 12 (time frame: Week 12). The study lists 9 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 NCT02767869, which also lists 1 linked publication.

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 14 Jan 2021.