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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Week 12
• Results posted on: 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=5 Participants	45.5 years STANDARD_DEVIATION 6.5 • n=7 Participants	45 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Mexico	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Body weight	76.5 kg STANDARD_DEVIATION 11.6 • n=5 Participants	78.8 kg STANDARD_DEVIATION 10.3 • n=7 Participants	77.6 kg STANDARD_DEVIATION 10.9 • n=5 Participants
Body mass index (BMI)	28.6 kg/m^2 STANDARD_DEVIATION 2.6 • n=5 Participants	28.6 kg/m^2 STANDARD_DEVIATION 3.8 • n=7 Participants	28.6 kg/m^2 STANDARD_DEVIATION 3.2 • n=5 Participants
Waist circumference	97.0 cm STANDARD_DEVIATION 7.8 • n=5 Participants	97.4 cm STANDARD_DEVIATION 8.8 • n=7 Participants	97.2 cm STANDARD_DEVIATION 8.3 • n=5 Participants
Systolic blood pressure	121.5 mmHg STANDARD_DEVIATION 12.9 • n=5 Participants	122.6 mmHg STANDARD_DEVIATION 9.6 • n=7 Participants	122.0 mmHg STANDARD_DEVIATION 11.2 • n=5 Participants
Diastolic blood pressure	76.5 mmHg STANDARD_DEVIATION 9.6 • n=5 Participants	81.7 mmHg STANDARD_DEVIATION 5.5 • n=7 Participants	79.1 mmHg STANDARD_DEVIATION 7.5 • n=5 Participants
Glucose 0'	106.9 mg/dL STANDARD_DEVIATION 7.9 • n=5 Participants	106.7 mg/dL STANDARD_DEVIATION 6.6 • n=7 Participants	106.8 mg/dL STANDARD_DEVIATION 7.2 • n=5 Participants
Glucose 120'	131.3 mg/dL STANDARD_DEVIATION 27.2 • n=5 Participants	138.3 mg/dL STANDARD_DEVIATION 28.2 • n=7 Participants	134.8 mg/dL STANDARD_DEVIATION 55.4 • n=5 Participants
Cholesterol	217.5 mg/dL STANDARD_DEVIATION 48.3 • n=5 Participants	197.7 mg/dL STANDARD_DEVIATION 37.3 • n=7 Participants	207.6 mg/dL STANDARD_DEVIATION 42.8 • n=5 Participants
Triglycerides	204.4 mg/dL STANDARD_DEVIATION 38.9 • n=5 Participants	200.8 mg/dL STANDARD_DEVIATION 80.6 • n=7 Participants	202.6 mg/dL STANDARD_DEVIATION 59.75 • n=5 Participants
High-density lipoprotein-cholesterol (HDL-C)	60.8 mg/dL STANDARD_DEVIATION 18.1 • n=5 Participants	57.3 mg/dL STANDARD_DEVIATION 20.4 • n=7 Participants	59.0 mg/dL STANDARD_DEVIATION 19.2 • n=5 Participants
Low-density lipoprotein-cholesterol (LDL-C)	108.1 mg/dL STANDARD_DEVIATION 39.3 • n=5 Participants	108.0 mg/dL STANDARD_DEVIATION 35.3 • n=7 Participants	108.0 mg/dL STANDARD_DEVIATION 37.3 • n=5 Participants
Area under the curve (AUC) glucose	18567.6 mg*min/dL STANDARD_DEVIATION 3480.6 • n=5 Participants	19336.3 mg*min/dL STANDARD_DEVIATION 3224.7 • n=7 Participants	18951.9 mg*min/dL STANDARD_DEVIATION 3352.6 • n=5 Participants
Area under the curve (AUC) insulin	8445.9 uU*min/mL STANDARD_DEVIATION 2384.8 • n=5 Participants	7669.7 uU*min/mL STANDARD_DEVIATION 2109.5 • n=7 Participants	8057.8 uU*min/mL STANDARD_DEVIATION 2247.1 • n=5 Participants
Very low-density lipoprotein (VLDL)	41.0 mg/dL STANDARD_DEVIATION 8.0 • n=5 Participants	40.1 mg/dL STANDARD_DEVIATION 7.7 • n=7 Participants	40.5 mg/dL STANDARD_DEVIATION 7.8 • n=5 Participants
Total insulin secretion	0.4 index STANDARD_DEVIATION 0.2 • n=5 Participants	0.4 index STANDARD_DEVIATION 0.1 • n=7 Participants	0.4 index STANDARD_DEVIATION 0.1 • n=5 Participants
First phase of insulin secretion	954.3 index STANDARD_DEVIATION 285.3 • n=5 Participants	910.3 index STANDARD_DEVIATION 514.1 • n=7 Participants	932.3 index STANDARD_DEVIATION 399.7 • n=5 Participants
Insulin sensitivity	5.2 index STANDARD_DEVIATION 1.4 • n=5 Participants	5.1 index STANDARD_DEVIATION 2.7 • n=7 Participants	5.1 index STANDARD_DEVIATION 2.0 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: 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 12

Population: 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 12

Population: 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 12

Population: 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 12

Population: 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 12

Population: 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 12

Population: 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 12

Population: 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 12

Population: 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 12

Population: 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 12

Population: 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 12

Population: 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 12

Population: 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

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

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

Phone: +52-33-10-58-52-00

Email: uiec@prodigy.net.mx

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place