Trial Outcomes & Findings for Effect of Irvingia Gabonensis Administration on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity (NCT NCT02354339)

NCT ID: NCT02354339

Last Updated: 2020-10-08

Results Overview

Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2020-10-08

Participant Flow

Participant milestones

Measure	Irvingia Gabonensis Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
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 Irvingia Gabonensis Administration on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity

Baseline characteristics by cohort

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals	Total n=24 Participants Total of all reporting groups
Age, Continuous	47.8 years STANDARD_DEVIATION 7.1 • n=5 Participants	47.8 years STANDARD_DEVIATION 6.1 • n=7 Participants	47.8 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 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
Fasting glucose	6.04 mmol/L STANDARD_DEVIATION 0.7 • n=5 Participants	5.9 mmol/L STANDARD_DEVIATION 0.5 • n=7 Participants	5.9 mmol/L STANDARD_DEVIATION 0.6 • n=5 Participants
Triglycerides	2.5 mmol/L STANDARD_DEVIATION 1.2 • n=5 Participants	2.2 mmol/L STANDARD_DEVIATION 0.6 • n=7 Participants	2.4 mmol/L STANDARD_DEVIATION 0.9 • n=5 Participants
High Density Lipoproteins (HDL-c)	1.4 mmol/L STANDARD_DEVIATION 0.3 • n=5 Participants	1.6 mmol/L STANDARD_DEVIATION 0.4 • n=7 Participants	1.5 mmol/L STANDARD_DEVIATION 0.4 • n=5 Participants
Systolic blood Pressure	125.3 mmHg STANDARD_DEVIATION 13.0 • n=5 Participants	128.4 mmHg STANDARD_DEVIATION 8.5 • n=7 Participants	126.8 mmHg STANDARD_DEVIATION 10.9 • n=5 Participants
Diastolic Blood Pressure	78.9 mmHg STANDARD_DEVIATION 7.4 • n=5 Participants	82.7 mmHg STANDARD_DEVIATION 8.0 • n=7 Participants	80.8 mmHg STANDARD_DEVIATION 7.8 • n=5 Participants
Waist circumference	94.0 centimeters STANDARD_DEVIATION 8.0 • n=5 Participants	96.9 centimeters STANDARD_DEVIATION 9.0 • n=7 Participants	95.5 centimeters STANDARD_DEVIATION 8.5 • n=5 Participants
First phase of insulin secretion	1306 index STANDARD_DEVIATION 1500 • n=5 Participants	2036 index STANDARD_DEVIATION 2115 • n=7 Participants	1670.9 index STANDARD_DEVIATION 1831.0 • n=5 Participants
Total insulin secretion	0.5 index STANDARD_DEVIATION 0.2 • n=5 Participants	0.8 index STANDARD_DEVIATION 0.5 • n=7 Participants	0.63 index STANDARD_DEVIATION 0.37 • n=5 Participants
Total insulin sensitivity	2.8 index STANDARD_DEVIATION 1.8 • n=5 Participants	1.9 index STANDARD_DEVIATION 0.9 • n=7 Participants	2.3 index STANDARD_DEVIATION 1.5 • n=5 Participants
Body weight	80.6 kilograms STANDARD_DEVIATION 13.0 • n=5 Participants	78.5 kilograms STANDARD_DEVIATION 9.2 • n=7 Participants	79.5 kilograms STANDARD_DEVIATION 11.1 • n=5 Participants
Body Mass Index	32.0 kg/m^2 STANDARD_DEVIATION 4.4 • n=5 Participants	31.2 kg/m^2 STANDARD_DEVIATION 3.9 • n=7 Participants	31.6 kg/m^2 STANDARD_DEVIATION 4.1 • n=5 Participants
Total cholesterol	5.7 mmol/L STANDARD_DEVIATION 0.6 • n=5 Participants	5.4 mmol/L STANDARD_DEVIATION 0.7 • n=7 Participants	5.5 mmol/L STANDARD_DEVIATION 0.7 • n=5 Participants
Low density lipoproteins (LDL-c)	3.4 mmol/L STANDARD_DEVIATION 1.0 • n=5 Participants	3.0 mmol/L STANDARD_DEVIATION 0.9 • n=7 Participants	3.2 mmol/L STANDARD_DEVIATION 0.7 • n=5 Participants
Alanine aminotransferase (ALT)	27.0 U/L STANDARD_DEVIATION 12.2 • n=5 Participants	33.8 U/L STANDARD_DEVIATION 27.1 • n=7 Participants	30.4 U/L STANDARD_DEVIATION 20.8 • n=5 Participants
Aspartate aminotransferase (AST)	27.5 U/L STANDARD_DEVIATION 16.7 • n=5 Participants	33.9 U/L STANDARD_DEVIATION 20.4 • n=7 Participants	30.7 U/L STANDARD_DEVIATION 18.5 • n=5 Participants
Creatinine	70.7 umol/L STANDARD_DEVIATION 17.7 • n=5 Participants	70.7 umol/L STANDARD_DEVIATION 17.7 • n=7 Participants	70.7 umol/L STANDARD_DEVIATION 17.7 • n=5 Participants
Uric acid	374.7 umol/L STANDARD_DEVIATION 148.7 • n=5 Participants	392.6 umol/L STANDARD_DEVIATION 59.5 • n=7 Participants	383.7 umol/L STANDARD_DEVIATION 110.0 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Fasting Glucose Levels at Week 12	5.7 mmol/L Standard Deviation 0.7	5.9 mmol/L Standard Deviation 0.7

PRIMARY outcome

Timeframe: 12 weeks

Triglycerides will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=11 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Triglycerides Levels at Week 12	2.0 mmol/L Standard Deviation 1.1	2.4 mmol/L Standard Deviation 1.8

PRIMARY outcome

Timeframe: 12 weeks

The HDL-C will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
High Density Lipoprotein (HDL-C) Levels at Week 12	1.9 mmol/L Standard Deviation 0.4	1.5 mmol/L Standard Deviation 0.2

PRIMARY outcome

Timeframe: 12 weeks

The systolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Systolic Blood Pressure at Week 12	123.5 mmHg Standard Deviation 10.6	126.5 mmHg Standard Deviation 12.1

PRIMARY outcome

Timeframe: Baseline. Week 12

The diastolic and blood pressure will be evaluated at baseline and at week 12 with a digital sphygmomanometer

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Diastolic Blood Pressure at Week 12.	77.5 mmHg Standard Deviation 7.3	81.1 mmHg Standard Deviation 11.4

PRIMARY outcome

Timeframe: 12 weeks

The waist circumference will be evaluated at baseline and at week 12 with a flexible validated metric tape

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Waist Circumference at Week 12	91.1 centimeters Standard Deviation 8.2	97.3 centimeters Standard Deviation 8.2

PRIMARY outcome

Timeframe: 12 weeks

The first phase of insulin secretion will be calculated at baseline and week 12 with the stumvoll index from concentrations of glucose and insulin obtained of an oral glucose tolerance test.

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 first phase of insulin secretion

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
First Phase of Insulin Secretion at Week 12	1382 index Standard Deviation 1119	1690 index Standard Deviation 1070

PRIMARY outcome

Timeframe: 12 weeks

Total insulin secretion will be calculated at baseline and week 12 with the insulinogenic index from concentrations of glucose and insulin obtained of an oral glucose tolerance test.

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 (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Total Insulin Secretion at Week 12	0.57 index Standard Deviation 0.20	0.8 index Standard Deviation 0.3

PRIMARY outcome

Timeframe: 12 weeks

Insulin sensitivity will be calculated at baseline and week 12 with the stumvoll index from concentrations of glucose and insulin obtained of an oral glucose tolerance test.

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

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Total Insulin Sensitivity at Week 12	3.5 index Standard Deviation 3.7	1.9 index Standard Deviation 1.2

SECONDARY outcome

Timeframe: 12 weeks

The body weight will be measured at baseline and week 12 with a bioimpedance balance.

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Body Weight at Week 12	80.5 kilograms Standard Deviation 12.8	79.0 kilograms Standard Deviation 9.2

SECONDARY outcome

Timeframe: 12 weeks

The body mass index will be calculated at baseline and week 12 with the Quetelet index

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Body Mass Index at Week 12	32.0 kg/m^2 Standard Deviation 4.3	31.4 kg/m^2 Standard Deviation 3.8

SECONDARY outcome

Timeframe: 12 weeks

Total cholesterol will be estimated bye standardized techniques at baseline and week 12

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Total Cholesterol at Week 12	5.8 mmol/L Standard Deviation 0.9	5.5 mmol/L Standard Deviation 0.7

SECONDARY outcome

Timeframe: 12 weeks

The LDL-C will be calculated at baseline and week 12 with the Friedewald formula

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Low Density Lipoproteins (LDL-C) at Week 12	3.2 mmol/L Standard Deviation 0.9	2.8 mmol/L Standard Deviation 0.8

SECONDARY outcome

Timeframe: 12 weeks

The aspartate aminotransferase will be determinated by standardized techniques at baseline and week 12

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Aspartate Aminotransferase at Week 12	27.5 U/L Standard Deviation 15.8	27.8 U/L Standard Deviation 16.4

SECONDARY outcome

Timeframe: 12 weeks

The alanine aminotransferase will be determinated by standardized techniques at baseline and week 12

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Alanine Aminotransferase at Week 12	27.3 U/L Standard Deviation 14.1	31.9 U/L Standard Deviation 23.7

SECONDARY outcome

Timeframe: 12 weeks

Creatinine levels will be measured at baseline and week 12 with standardized techniques

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Creatinine at Week 12	61.9 umol/L Standard Deviation 17.7	70.7 umol/L Standard Deviation 17.7

SECONDARY outcome

Timeframe: 12 weeks

Uric acid levels will be measured at baseline and week 12 with standardized techniques

Outcome measures

Measure	Irvingia Gabonensis n=12 Participants Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 Participants Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Uric Acid at Week 12	345.0 umol/L Standard Deviation 53.5	404.5 umol/L Standard Deviation 119.0

Adverse Events

Irvingia Gabonensis

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Irvingia Gabonensis n=12 participants at risk Irvingia gabonensis will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Irvingia gabonensis: Intervention will be administered 30 minutes before meals	Placebo n=12 participants at risk Placebo will be administered 150 mg before breakfast and 150 before dinner during 12 weeks Placebo: Intervention will be administered 30 minutes before meals
Gastrointestinal disorders Constipation	8.3% 1/12 • Number of events 1 • Adverse events were collected during the 12 weeks of the study.	16.7% 2/12 • Number of events 2 • Adverse events were collected during the 12 weeks of the study.

Additional Information

DR. MANUEL GONZALEZ ORTIZ

INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA

Phone: +52 3310585200

Email: uice@prodigy.net.mx

Results disclosure agreements

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