Trial Outcomes & Findings for Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance (NCT NCT02621060)
NCT ID: NCT02621060
Last Updated: 2019-08-02
Results Overview
Reflect the fasting glucose level after a 10- to 12-h overnight fast.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Week 12.
Results posted on
2019-08-02
Participant Flow
Participant milestones
| Measure |
Placebo
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=15 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 9 • n=99 Participants
|
43 years
STANDARD_DEVIATION 11 • n=107 Participants
|
44 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Body weight
|
81.3 kg
STANDARD_DEVIATION 8 • n=99 Participants
|
83.3 kg
STANDARD_DEVIATION 9.8 • n=107 Participants
|
82.3 kg
STANDARD_DEVIATION 8.9 • n=206 Participants
|
|
Body mass index
|
32.1 kg/m^2
STANDARD_DEVIATION 2.5 • n=99 Participants
|
32.6 kg/m^2
STANDARD_DEVIATION 2.4 • n=107 Participants
|
32.4 kg/m^2
STANDARD_DEVIATION 2.4 • n=206 Participants
|
|
Waist circumference
|
103 cm
STANDARD_DEVIATION 7 • n=99 Participants
|
106 cm
STANDARD_DEVIATION 10 • n=107 Participants
|
105 cm
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Systolic blood pressure
|
120 mmHg
STANDARD_DEVIATION 6 • n=99 Participants
|
115 mmHg
STANDARD_DEVIATION 11 • n=107 Participants
|
117 mmHg
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Diastolic blood pressure
|
77 mmHg
STANDARD_DEVIATION 6 • n=99 Participants
|
77 mmHg
STANDARD_DEVIATION 11 • n=107 Participants
|
77 mmHg
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Fasting plasma glucose
|
5.7 mmol/L
STANDARD_DEVIATION 0.4 • n=99 Participants
|
5.7 mmol/L
STANDARD_DEVIATION 0.4 • n=107 Participants
|
5.7 mmol/L
STANDARD_DEVIATION 0.4 • n=206 Participants
|
|
2-hour plasma glucose
|
9.0 mmol/L
STANDARD_DEVIATION 0.5 • n=99 Participants
|
8.8 mmol/L
STANDARD_DEVIATION 0.6 • n=107 Participants
|
8.9 mmol/L
STANDARD_DEVIATION 0.6 • n=206 Participants
|
|
Glycated hemoglobin A1c
|
5.6 Percent of glycated hemoglobin
STANDARD_DEVIATION 0.5 • n=99 Participants
|
5.5 Percent of glycated hemoglobin
STANDARD_DEVIATION 0.3 • n=107 Participants
|
5.5 Percent of glycated hemoglobin
STANDARD_DEVIATION 0.4 • n=206 Participants
|
|
Triglycerides
|
1.6 mmol/L
STANDARD_DEVIATION 0.7 • n=99 Participants
|
1.6 mmol/L
STANDARD_DEVIATION 0.6 • n=107 Participants
|
1.6 mmol/L
STANDARD_DEVIATION 0.7 • n=206 Participants
|
|
Total cholesterol
|
4.9 mmol/L
STANDARD_DEVIATION 1.0 • n=99 Participants
|
4.5 mmol/L
STANDARD_DEVIATION 0.6 • n=107 Participants
|
4.7 mmol/L
STANDARD_DEVIATION 0.8 • n=206 Participants
|
|
High-density lipoprotein cholesterol (HDL-C)
|
1.5 mmol/L
STANDARD_DEVIATION 0.4 • n=99 Participants
|
1.7 mmol/L
STANDARD_DEVIATION 0.4 • n=107 Participants
|
1.6 mmol/L
STANDARD_DEVIATION 0.4 • n=206 Participants
|
|
Low-density lipoprotein cholesterol (LDL-C)
|
2.6 mmol/L
STANDARD_DEVIATION 1.1 • n=99 Participants
|
2.3 mmol/L
STANDARD_DEVIATION 1.0 • n=107 Participants
|
2.5 mmol/L
STANDARD_DEVIATION 1.1 • n=206 Participants
|
|
Very low-density lipoprotein (VLDL)
|
0.77 mmol/L
STANDARD_DEVIATION 0.36 • n=99 Participants
|
0.72 mmol/L
STANDARD_DEVIATION 0.30 • n=107 Participants
|
0.75 mmol/L
STANDARD_DEVIATION 0.40 • n=206 Participants
|
|
Glutamic oxaloacetic transaminase (GOT)
|
21.46 IU/L
STANDARD_DEVIATION 14.72 • n=99 Participants
|
18.16 IU/L
STANDARD_DEVIATION 5.92 • n=107 Participants
|
19.81 IU/L
STANDARD_DEVIATION 11.15 • n=206 Participants
|
|
Glutamic pyruvic transaminase (GPT)
|
24.25 IU/L
STANDARD_DEVIATION 8.51 • n=99 Participants
|
20.93 IU/L
STANDARD_DEVIATION 9.73 • n=107 Participants
|
23.02 IU/L
STANDARD_DEVIATION 10.60 • n=206 Participants
|
|
Creatinine
|
0.05 mmol/L
STANDARD_DEVIATION 0.02 • n=99 Participants
|
0.05 mmol/L
STANDARD_DEVIATION 0.02 • n=107 Participants
|
0.05 mmol/L
STANDARD_DEVIATION 0.02 • n=206 Participants
|
|
Uric Acid
|
0.32 mmol/L
STANDARD_DEVIATION 0.06 • n=99 Participants
|
0.29 mmol/L
STANDARD_DEVIATION 0.05 • n=107 Participants
|
0.3 mmol/L
STANDARD_DEVIATION 0.05 • n=206 Participants
|
|
Area under the curve of glucose (AUCG)
|
1139 mmol/L/min
STANDARD_DEVIATION 154 • n=99 Participants
|
1119 mmol/L/min
STANDARD_DEVIATION 147 • n=107 Participants
|
1129 mmol/L/min
STANDARD_DEVIATION 50 • n=206 Participants
|
|
Area under the curve of insulin (AUCI)
|
72,298 pmol/L/min
STANDARD_DEVIATION 24,627 • n=99 Participants
|
76,993 pmol/L/min
STANDARD_DEVIATION 26,480 • n=107 Participants
|
74,645 pmol/L/min
STANDARD_DEVIATION 25,238 • n=206 Participants
|
|
Total insulin secretion
|
0.58 Unitless
STANDARD_DEVIATION 0.21 • n=99 Participants
|
0.71 Unitless
STANDARD_DEVIATION 0.25 • n=107 Participants
|
0.65 Unitless
STANDARD_DEVIATION 0.24 • n=206 Participants
|
|
First phase of insulin secretion
|
1248 Unitless
STANDARD_DEVIATION 701 • n=99 Participants
|
1331 Unitless
STANDARD_DEVIATION 628 • n=107 Participants
|
1289 Unitless
STANDARD_DEVIATION 655 • n=206 Participants
|
|
Insulin sensitivity
|
2.17 Unitless
STANDARD_DEVIATION 0.71 • n=99 Participants
|
1.98 Unitless
STANDARD_DEVIATION 0.88 • n=107 Participants
|
2.07 Unitless
STANDARD_DEVIATION 0.79 • n=206 Participants
|
PRIMARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
Reflect the fasting glucose level after a 10- to 12-h overnight fast.
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Fasting Plasma Glucose (FPG)
|
5.8 mmol/L
Standard Deviation 0.3
|
5.5 mmol/L
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
Subjects underwent a 2-h oral glucose tolerance test (2-h OGTT) by consuming 75-g of a dextrose load, and one sample was obtained 120 min after glucose administration.
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
2 Hours Plasma Glucose (2-h PG)
|
9.0 mmol/L
Standard Deviation 0.8
|
8.5 mmol/L
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
Shows what a person's average blood glucose level was for the 2 to 3 months before the test high-performance.
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Glycated Hemoglobin A1c (A1C)
|
5.8 Percentage of A1C
Standard Deviation 0.3
|
5.5 Percentage of A1C
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Total Insulin Secretion
|
0.55 Unitless
Standard Deviation 0.26
|
0.63 Unitless
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
After intervention with Stumvoll index
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
First Phase of Insulin Secretion
|
1281 Unitless
Standard Deviation 818
|
1133 Unitless
Standard Deviation 601
|
PRIMARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
After intervention Matsuda Index
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Insulin Sensitivity
|
2.43 Unitless
Standard Deviation 0.88
|
2.30 Unitless
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
Area under the curve of glucose was obtained using the trapezoidal integration.
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Area Under the Curve of Glucose
|
1187 mmol/l/min
Standard Deviation 130
|
1145 mmol/l/min
Standard Deviation 199
|
SECONDARY outcome
Timeframe: Week 12.Before and after intervention area under the curve of insulin
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Area Under the Curve of Insulin
|
67,322 pmol/L/min
Standard Deviation 31,531
|
72,857 pmol/L/min
Standard Deviation 29,414
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Body Weight
|
81.3 kg
Standard Deviation 7.9
|
80.8 kg
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Body Mass Index
|
32.0 kg/m^2
Standard Deviation 2.6
|
31.4 kg/m^2
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Waist Circumference (WC)
|
102 cm
Standard Deviation 5
|
104 cm
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Systolic Blood Pressure (SBP)
|
118 mmHg
Standard Deviation 9
|
113 mmHg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
The Diastolic blood plessure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Diastolic Blood Plessure (DBP)
|
78 mmHg
Standard Deviation 7
|
74 mmHg
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
The 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 |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Triglycerides (TG)
|
1.7 mmol/L
Standard Deviation 0.7
|
1.3 mmol/L
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
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 |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Total Cholesterol (TC)
|
5.3 mmol/L
Standard Deviation 0.9
|
4.3 mmol/L
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
The HDL-C levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the HDL-C level at week 12
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
High-density Lipoprotein Cholesterol (HDL-C)
|
1.5 mmol/L
Standard Deviation 0.3
|
1.8 mmol/L
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the LDL-C levels at week 12
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Low-density Lipoprotein Cholesterol (LDL-C)
|
2.7 mmol/L
Standard Deviation 0.8
|
1.9 mmol/L
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
The VLDL 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 |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Very-low Density Lipoprotein (VLDL)
|
0.77 mmol/L
Standard Deviation 0.32
|
0.61 mmol/L
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
Before and after intervention by spectrophotometry
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Glutamic Pyruvic Transaminase (GPT)
|
25.25 IU/L
Standard Deviation 13.46
|
22.64 IU/L
Standard Deviation 15.71
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
Before and after intervention by spectrophotometry
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Glutamic Oxaloacetic Transaminase (GOT)
|
22.03 IU/L
Standard Deviation 10.91
|
17.79 IU/L
Standard Deviation 8.73
|
SECONDARY outcome
Timeframe: Week 12.The creatinine 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 |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Creatinine
|
0.06 mmol/L
Standard Deviation 0.04
|
0.06 mmol/L
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Week 12.Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinina levels at week 12.
Outcome measures
| Measure |
Placebo
n=12 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=14 Participants
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Uric Acid
|
0.34 mmol/l
Standard Deviation 0.06
|
0.30 mmol/l
Standard Deviation 0.09
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Chlorogenic Acid
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 |
Placebo
n=15 participants at risk
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months
|
Chlorogenic Acid
n=15 participants at risk
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months
|
|---|---|---|
|
Gastrointestinal disorders
Diarrea
|
20.0%
3/15 • Adverse events were collected thoughtout the 90 days of the study
|
6.7%
1/15 • Adverse events were collected thoughtout the 90 days of the study
|
|
Nervous system disorders
Headacha
|
0.00%
0/15 • Adverse events were collected thoughtout the 90 days of the study
|
13.3%
2/15 • Adverse events were collected thoughtout the 90 days of the study
|
|
Renal and urinary disorders
polyuria
|
13.3%
2/15 • Adverse events were collected thoughtout the 90 days of the study
|
6.7%
1/15 • Adverse events were collected thoughtout the 90 days of the study
|
|
Gastrointestinal disorders
abdominal pain
|
6.7%
1/15 • Adverse events were collected thoughtout the 90 days of the study
|
6.7%
1/15 • Adverse events were collected thoughtout the 90 days of the study
|
|
Gastrointestinal disorders
abdominal distention
|
6.7%
1/15 • Adverse events were collected thoughtout the 90 days of the study
|
0.00%
0/15 • Adverse events were collected thoughtout the 90 days of the study
|
Additional Information
Dra. Esperanza Martínez Abundis
Institute of Experimental and Clinical Therapeutics
Phone: +52-33-10-58-52-00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place