Trial Outcomes & Findings for Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome (NCT NCT02337933)
NCT ID: NCT02337933
Last Updated: 2020-10-08
Results Overview
The insulin sensitivity was calculated at baseline and at week 12. The value reported corresponds at week 12 with Matsuda index. 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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Week 12
Results posted on
2020-10-08
Participant Flow
Participant milestones
| Measure |
Ursolic Acid
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
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 Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 8.5 • n=39 Participants
|
46.5 years
STANDARD_DEVIATION 8.7 • n=41 Participants
|
45.1 years
STANDARD_DEVIATION 8.6 • n=35 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Region of Enrollment
Mexico
|
12 participants
n=39 Participants
|
12 participants
n=41 Participants
|
24 participants
n=35 Participants
|
|
Total Insulin Sensitivity
|
3.1 index
STANDARD_DEVIATION 1.1 • n=39 Participants
|
3.1 index
STANDARD_DEVIATION 0.6 • n=41 Participants
|
3.1 index
STANDARD_DEVIATION 0.8 • n=35 Participants
|
|
Waist Circumference
|
93 cm
STANDARD_DEVIATION 9 • n=39 Participants
|
97 cm
STANDARD_DEVIATION 10 • n=41 Participants
|
95 cm
STANDARD_DEVIATION 10 • n=35 Participants
|
|
Fasting Glucose
|
6.0 mmol/L
STANDARD_DEVIATION 0.5 • n=39 Participants
|
5.8 mmol/L
STANDARD_DEVIATION 0.9 • n=41 Participants
|
5.9 mmol/L
STANDARD_DEVIATION 0.7 • n=35 Participants
|
|
Triglycerides
|
2.0 mmol/L
STANDARD_DEVIATION 0.6 • n=39 Participants
|
2.5 mmol/L
STANDARD_DEVIATION 0.1 • n=41 Participants
|
2.3 mmol/L
STANDARD_DEVIATION 0.4 • n=35 Participants
|
|
High Density Lipoprotein cholesterol (HDL-c)
|
1.6 mmol/L
STANDARD_DEVIATION 0.6 • n=39 Participants
|
1.8 mmol/L
STANDARD_DEVIATION 0.7 • n=41 Participants
|
1.7 mmol/L
STANDARD_DEVIATION 0.7 • n=35 Participants
|
|
Systolic Blood Pressure
|
125 mmHg
STANDARD_DEVIATION 13 • n=39 Participants
|
128 mmHg
STANDARD_DEVIATION 20 • n=41 Participants
|
127 mmHg
STANDARD_DEVIATION 17 • n=35 Participants
|
|
Diastolic Blood Pressure
|
77 mmHg
STANDARD_DEVIATION 12 • n=39 Participants
|
80 mmHg
STANDARD_DEVIATION 10 • n=41 Participants
|
78 mmHg
STANDARD_DEVIATION 11 • n=35 Participants
|
|
Body Weight
|
75.7 kg
STANDARD_DEVIATION 11.5 • n=39 Participants
|
81.5 kg
STANDARD_DEVIATION 14.0 • n=41 Participants
|
78.6 kg
STANDARD_DEVIATION 12.8 • n=35 Participants
|
|
Body Mass Index
|
29.9 kg/m^2
STANDARD_DEVIATION 3.6 • n=39 Participants
|
31.7 kg/m^2
STANDARD_DEVIATION 4.2 • n=41 Participants
|
30.8 kg/m^2
STANDARD_DEVIATION 3.9 • n=35 Participants
|
|
Total Cholesterol
|
6.0 mmol/L
STANDARD_DEVIATION 1.4 • n=39 Participants
|
6.0 mmol/L
STANDARD_DEVIATION 2.0 • n=41 Participants
|
6.0 mmol/L
STANDARD_DEVIATION 1.7 • n=35 Participants
|
|
Low Density Lipoproteins cholesterol (LDL-c)
|
3.7 mmol/L
STANDARD_DEVIATION 1.1 • n=39 Participants
|
3.5 mmol/L
STANDARD_DEVIATION 2.1 • n=41 Participants
|
3.6 mmol/L
STANDARD_DEVIATION 1.6 • n=35 Participants
|
|
Creatinine
|
61.1 µmol/L
STANDARD_DEVIATION 18.6 • n=39 Participants
|
68.1 µmol/L
STANDARD_DEVIATION 15.0 • n=41 Participants
|
64.6 µmol/L
STANDARD_DEVIATION 16.8 • n=35 Participants
|
|
Uric acid
|
243.9 µmol/L
STANDARD_DEVIATION 53.5 • n=39 Participants
|
291.5 µmol/L
STANDARD_DEVIATION 71.4 • n=41 Participants
|
267.7 µmol/L
STANDARD_DEVIATION 62.5 • n=35 Participants
|
PRIMARY outcome
Timeframe: Week 12The insulin sensitivity was calculated at baseline and at week 12. The value reported corresponds at week 12 with Matsuda index. 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 |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Total Insulin Sensitivity
|
4.2 index
Standard Deviation 1.2
|
2.6 index
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Week 12Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12
Outcome measures
| Measure |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Waist Circumference
|
83 cm
Standard Deviation 9
|
96 cm
Standard Deviation 8
|
PRIMARY outcome
Timeframe: Week 12The 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 |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Fasting Glucose
|
4.7 mmol/L
Standard Deviation 0.4
|
5.7 mmol/L
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Week 12The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12
Outcome measures
| Measure |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Triglycerides
|
1.8 mmol/L
Standard Deviation 0.8
|
2.5 mmol/L
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Week 12The HDL-c levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
Outcome measures
| Measure |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
High Density Lipoprotein Cholesterol (HDL-c)
|
1.8 mmol/L
Standard Deviation 0.9
|
1.8 mmol/L
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Week 12The 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 |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Systolic Blood Pressure
|
120 mmHg
Standard Deviation 8
|
124 mmHg
Standard Deviation 15
|
PRIMARY outcome
Timeframe: Week 12The 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 |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Diastolic Blood Pressure
|
76 mmHg
Standard Deviation 6
|
76 mmHg
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Week 12The body 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 |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Body Weight
|
71 kg
Standard Deviation 11
|
81 kg
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Week 12The 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 |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Body Mass Index
|
24.9 kg/m^2
Standard Deviation 1.2
|
32.1 kg/m^2
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Week 12The 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 |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Total Cholesterol
|
5.2 mmol/L
Standard Deviation 1.2
|
6.4 mmol/L
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Week 12The 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 |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Low Density Lipoproteins Cholesterol (LDL-c)
|
2.8 mmol/L
Standard Deviation 1.2
|
4.3 mmol/L
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Week 12The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12
Outcome measures
| Measure |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Creatinine
|
0.06 mmol/L
Standard Deviation 0.02
|
0.06 mmol/L
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Week 12The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12
Outcome measures
| Measure |
Ursolic Acid
n=12 Participants
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 Participants
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Uric Acid
|
249.8 µmol/L
Standard Deviation 53.5
|
422.3 µmol/L
Standard Deviation 124.9
|
Adverse Events
Ursolic Acid
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ursolic Acid
n=12 participants at risk
Ursolic acid capsules, 150 mg, once a day before breakfast during 12 weeks
Ursolic acid: Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
|
Placebo
n=12 participants at risk
Calcined magnesia capsules, 150 mg, once a day before breakfast during 12 weeks
Placebo: Calcined magnesia capsules of 150 mg, once a day before breakfast
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distention
|
25.0%
3/12 • Number of events 3 • Throughout the study (12 weeks)
|
16.7%
2/12 • Number of events 2 • Throughout the study (12 weeks)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • Throughout the study (12 weeks)
|
16.7%
2/12 • Number of events 2 • Throughout the study (12 weeks)
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Number of events 1 • Throughout the study (12 weeks)
|
16.7%
2/12 • Number of events 2 • Throughout the study (12 weeks)
|
Additional Information
DR. MANUEL GONZALEZ ORTIZ
INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA
Phone: +52 3310585200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place