Trial Outcomes & Findings for Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity (NCT NCT02767869)
NCT ID: NCT02767869
Last Updated: 2021-01-14
Results Overview
The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.
COMPLETED
PHASE2
24 participants
Week 12
2021-01-14
Participant Flow
Participant milestones
| Measure |
Banaba
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Baseline characteristics by cohort
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
45.5 years
STANDARD_DEVIATION 6.5 • n=107 Participants
|
45 years
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Body weight
|
76.5 kg
STANDARD_DEVIATION 11.6 • n=99 Participants
|
78.8 kg
STANDARD_DEVIATION 10.3 • n=107 Participants
|
77.6 kg
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Body mass index (BMI)
|
28.6 kg/m^2
STANDARD_DEVIATION 2.6 • n=99 Participants
|
28.6 kg/m^2
STANDARD_DEVIATION 3.8 • n=107 Participants
|
28.6 kg/m^2
STANDARD_DEVIATION 3.2 • n=206 Participants
|
|
Waist circumference
|
97.0 cm
STANDARD_DEVIATION 7.8 • n=99 Participants
|
97.4 cm
STANDARD_DEVIATION 8.8 • n=107 Participants
|
97.2 cm
STANDARD_DEVIATION 8.3 • n=206 Participants
|
|
Systolic blood pressure
|
121.5 mmHg
STANDARD_DEVIATION 12.9 • n=99 Participants
|
122.6 mmHg
STANDARD_DEVIATION 9.6 • n=107 Participants
|
122.0 mmHg
STANDARD_DEVIATION 11.2 • n=206 Participants
|
|
Diastolic blood pressure
|
76.5 mmHg
STANDARD_DEVIATION 9.6 • n=99 Participants
|
81.7 mmHg
STANDARD_DEVIATION 5.5 • n=107 Participants
|
79.1 mmHg
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Glucose 0'
|
106.9 mg/dL
STANDARD_DEVIATION 7.9 • n=99 Participants
|
106.7 mg/dL
STANDARD_DEVIATION 6.6 • n=107 Participants
|
106.8 mg/dL
STANDARD_DEVIATION 7.2 • n=206 Participants
|
|
Glucose 120'
|
131.3 mg/dL
STANDARD_DEVIATION 27.2 • n=99 Participants
|
138.3 mg/dL
STANDARD_DEVIATION 28.2 • n=107 Participants
|
134.8 mg/dL
STANDARD_DEVIATION 55.4 • n=206 Participants
|
|
Cholesterol
|
217.5 mg/dL
STANDARD_DEVIATION 48.3 • n=99 Participants
|
197.7 mg/dL
STANDARD_DEVIATION 37.3 • n=107 Participants
|
207.6 mg/dL
STANDARD_DEVIATION 42.8 • n=206 Participants
|
|
Triglycerides
|
204.4 mg/dL
STANDARD_DEVIATION 38.9 • n=99 Participants
|
200.8 mg/dL
STANDARD_DEVIATION 80.6 • n=107 Participants
|
202.6 mg/dL
STANDARD_DEVIATION 59.75 • n=206 Participants
|
|
High-density lipoprotein-cholesterol (HDL-C)
|
60.8 mg/dL
STANDARD_DEVIATION 18.1 • n=99 Participants
|
57.3 mg/dL
STANDARD_DEVIATION 20.4 • n=107 Participants
|
59.0 mg/dL
STANDARD_DEVIATION 19.2 • n=206 Participants
|
|
Low-density lipoprotein-cholesterol (LDL-C)
|
108.1 mg/dL
STANDARD_DEVIATION 39.3 • n=99 Participants
|
108.0 mg/dL
STANDARD_DEVIATION 35.3 • n=107 Participants
|
108.0 mg/dL
STANDARD_DEVIATION 37.3 • n=206 Participants
|
|
Area under the curve (AUC) glucose
|
18567.6 mg*min/dL
STANDARD_DEVIATION 3480.6 • n=99 Participants
|
19336.3 mg*min/dL
STANDARD_DEVIATION 3224.7 • n=107 Participants
|
18951.9 mg*min/dL
STANDARD_DEVIATION 3352.6 • n=206 Participants
|
|
Area under the curve (AUC) insulin
|
8445.9 uU*min/mL
STANDARD_DEVIATION 2384.8 • n=99 Participants
|
7669.7 uU*min/mL
STANDARD_DEVIATION 2109.5 • n=107 Participants
|
8057.8 uU*min/mL
STANDARD_DEVIATION 2247.1 • n=206 Participants
|
|
Very low-density lipoprotein (VLDL)
|
41.0 mg/dL
STANDARD_DEVIATION 8.0 • n=99 Participants
|
40.1 mg/dL
STANDARD_DEVIATION 7.7 • n=107 Participants
|
40.5 mg/dL
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Total insulin secretion
|
0.4 index
STANDARD_DEVIATION 0.2 • n=99 Participants
|
0.4 index
STANDARD_DEVIATION 0.1 • n=107 Participants
|
0.4 index
STANDARD_DEVIATION 0.1 • n=206 Participants
|
|
First phase of insulin secretion
|
954.3 index
STANDARD_DEVIATION 285.3 • n=99 Participants
|
910.3 index
STANDARD_DEVIATION 514.1 • n=107 Participants
|
932.3 index
STANDARD_DEVIATION 399.7 • n=206 Participants
|
|
Insulin sensitivity
|
5.2 index
STANDARD_DEVIATION 1.4 • n=99 Participants
|
5.1 index
STANDARD_DEVIATION 2.7 • n=107 Participants
|
5.1 index
STANDARD_DEVIATION 2.0 • n=206 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Triglyceride Levels at Week 12
|
148.0 mg/dL
Standard Deviation 43.0
|
199.9 mg/dL
Standard Deviation 101.9
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques.
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12
|
56.4 mg/dL
Standard Deviation 11.2
|
58.4 mg/dL
Standard Deviation 16
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
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
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Fasting Glucose Levels at Week 12
|
103.2 mg/dL
Standard Deviation 7.4
|
104.2 mg/dL
Standard Deviation 8.9
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
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
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Systolic Blood Pressure at Week 12.
|
116.3 mmHg
Standard Deviation 9.8
|
122.6 mmHg
Standard Deviation 13.1
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
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.
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
First Phase of Insulin Secretion at Week 12
|
913.9 index
Standard Deviation 490.3
|
651.0 index
Standard Deviation 405.2
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
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.
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Total Insulin Secretion at Week 12.
|
0.3 index
Standard Deviation 0.2
|
0.3 index
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
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.
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Total Insulin Sensitivity at Week 12
|
5.1 index
Standard Deviation 3.2
|
5.5 index
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
Waist circumference will be evaluated at baseline and at week 12 with a flexible tape
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Waist Circumference at Week 12
|
95.7 cm
Standard Deviation 7.9
|
97.0 cm
Standard Deviation 7.8
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
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
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Diastolic Blood Pressure at Week 12
|
72.5 mmHg
Standard Deviation 9.2
|
76.5 mmHg
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
The weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Weight at Week 12
|
72.6 kg
Standard Deviation 8.6
|
72.2 kg
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
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
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Body Mass Index at Week 12
|
28.4 kg/m^2
Standard Deviation 2.7
|
28.9 kg/m^2
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
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
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Total Cholesterol at Week 12
|
210.0 mg/dL
Standard Deviation 39.6
|
201.7 mg/dL
Standard Deviation 34.8
|
SECONDARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
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
Outcome measures
| Measure |
Banaba
n=12 Participants
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 Participants
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Low-density Lipoprotein-cholesterol (LDL-C) at Week 12
|
29.0 mg/dL
Standard Deviation 8.0
|
39.9 mg/dL
Standard Deviation 20.3
|
Adverse Events
Banaba
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Banaba
n=12 participants at risk
Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
|
Placebo
n=12 participants at risk
Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
|
|---|---|---|
|
Gastrointestinal disorders
softening of stool
|
75.0%
9/12 • Number of events 9 • Adverse events were collected throughout the 12-week study.
|
0.00%
0/12 • Adverse events were collected throughout the 12-week study.
|
|
Gastrointestinal disorders
abdominal colic
|
25.0%
3/12 • Number of events 3 • Adverse events were collected throughout the 12-week study.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected throughout the 12-week study.
|
|
Gastrointestinal disorders
flatulence
|
16.7%
2/12 • Number of events 2 • Adverse events were collected throughout the 12-week study.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected throughout the 12-week study.
|
|
Gastrointestinal disorders
abdominal swelling
|
8.3%
1/12 • Number of events 1 • Adverse events were collected throughout the 12-week study.
|
33.3%
4/12 • Number of events 4 • Adverse events were collected throughout the 12-week study.
|
|
Gastrointestinal disorders
pyrosis
|
0.00%
0/12 • Adverse events were collected throughout the 12-week study.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected throughout the 12-week study.
|
Additional Information
Dr. Manuel González Ortiz
Institute of Experimental andl Clinical Therapeutics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place