Impaired Glucose Tolerance
Conditions
Keywords
Chlorogenic acid, Control glucose, Insulin Secretion, Insulin Sensitivity
Brief summary
Chlorogenic acid has demonstrated promising effects in the treatment of glycemic control, obesity, dyslipidemia, insulin secretion, among others. The above mentioned findings show that Chlorogenic acid has an excellent potential for the control of glucose as well as insulin secretion and insulin sensitivity.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial was carried out in 30 patients with a diagnosis of impaired glucose tolerance in accordance with the American Diabetes Association criteria. The patients received 400 mg capsules of Chlorogenic acid or placebo, three times daily 1/ 2 hour before meals for 90 days. Before and after intervention the investigators evaluated: 2 hours plasma glucose, glycated hemoglobin (A1C), triglycerides, high-density lipoprotein, fasting glucose and blood pressure body weight, body mass index, waist circumference, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase. Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.
Interventions
DRUGPlacebo
Placebo: 1200 mg per day for three months
DRUGChlorogenic acid
Chologenic acid: 1200 mg per day for three months
Sponsors
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* BMI: 30.0-34.99 kg / m2. * Diagnosis of IGT (OGTT Values between 140mg / dl and 199mg / dl. * Written informed consent. * Body weight stable over the last 3 months. * Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests. * Women who are not contemplated get pregnant within the next 6 months.
Exclusion criteria
* Women pregnant or breastfeeding. * Physical or mental disability that makes it impossible to perform the intervention. * Diagnosis of Hypertension or heart failure. * Smokers. * Untreated thyroid disease. * Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering). * Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes. * Diagnosis of renal disease or creatinine \> 1.5 mg / dl. * Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%. * Total Cholesterol ≥ 280 mg/dL. * Triglycerids ≥ 300 mg/dL. * Known allergy to calcined magnesia or Chorogenic acid.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Plasma Glucose (FPG) | Week 12. | Reflect the fasting glucose level after a 10- to 12-h overnight fast. |
| 2 Hours Plasma Glucose (2-h PG) | Week 12. | 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. |
| Glycated Hemoglobin A1c (A1C) | Week 12. | Shows what a person's average blood glucose level was for the 2 to 3 months before the test high-performance. |
| Total Insulin Secretion | Week 12. | After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose). |
| First Phase of Insulin Secretion | Week 12. | After intervention with Stumvoll index |
| Insulin Sensitivity | Week 12. | After intervention Matsuda Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) | Week 12. | 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 |
| Diastolic Blood Plessure (DBP) | Week 12. | 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 |
| Triglycerides (TG) | Week 12. | The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12 |
| Total Cholesterol (TC) | Week 12. | 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 |
| High-density Lipoprotein Cholesterol (HDL-C) | Week 12. | 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 |
| Uric Acid | Week 12. | 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. |
| Very-low Density Lipoprotein (VLDL) | Week 12. | 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 |
| Glutamic Pyruvic Transaminase (GPT) | Week 12. | Before and after intervention by spectrophotometry |
| Glutamic Oxaloacetic Transaminase (GOT) | Week 12. | Before and after intervention by spectrophotometry |
| Creatinine | 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 |
| Low-density Lipoprotein Cholesterol (LDL-C) | Week 12. | 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 |
| Area Under the Curve of Glucose | Week 12. | Area under the curve of glucose was obtained using the trapezoidal integration. |
| Area Under the Curve of Insulin | Week 12. | Before and after intervention area under the curve of insulin |
| Body Weight | Week 12. | 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 |
| Body Mass Index | 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 |
| Waist Circumference (WC) | Week 12. | 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 |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Placebo | Total | Chlorogenic Acid |
|---|---|---|---|
| 2-hour plasma glucose | 9.0 mmol/L STANDARD_DEVIATION 0.5 | 8.9 mmol/L STANDARD_DEVIATION 0.6 | 8.8 mmol/L STANDARD_DEVIATION 0.6 |
| Age, Continuous | 45 years STANDARD_DEVIATION 9 | 44 years STANDARD_DEVIATION 10 | 43 years STANDARD_DEVIATION 11 |
| Area under the curve of glucose (AUCG) | 1139 mmol/L/min STANDARD_DEVIATION 154 | 1129 mmol/L/min STANDARD_DEVIATION 50 | 1119 mmol/L/min STANDARD_DEVIATION 147 |
| Area under the curve of insulin (AUCI) | 72,298 pmol/L/min | 74,645 pmol/L/min | 76,993 pmol/L/min |
| Body mass index | 32.1 kg/m^2 STANDARD_DEVIATION 2.5 | 32.4 kg/m^2 STANDARD_DEVIATION 2.4 | 32.6 kg/m^2 STANDARD_DEVIATION 2.4 |
| Body weight | 81.3 kg STANDARD_DEVIATION 8 | 82.3 kg STANDARD_DEVIATION 8.9 | 83.3 kg STANDARD_DEVIATION 9.8 |
| Creatinine | 0.05 mmol/L STANDARD_DEVIATION 0.02 | 0.05 mmol/L STANDARD_DEVIATION 0.02 | 0.05 mmol/L STANDARD_DEVIATION 0.02 |
| Diastolic blood pressure | 77 mmHg STANDARD_DEVIATION 6 | 77 mmHg STANDARD_DEVIATION 9 | 77 mmHg STANDARD_DEVIATION 11 |
| Fasting plasma glucose | 5.7 mmol/L STANDARD_DEVIATION 0.4 | 5.7 mmol/L STANDARD_DEVIATION 0.4 | 5.7 mmol/L STANDARD_DEVIATION 0.4 |
| First phase of insulin secretion | 1248 Unitless STANDARD_DEVIATION 701 | 1289 Unitless STANDARD_DEVIATION 655 | 1331 Unitless STANDARD_DEVIATION 628 |
| Glutamic oxaloacetic transaminase (GOT) | 21.46 IU/L STANDARD_DEVIATION 14.72 | 19.81 IU/L STANDARD_DEVIATION 11.15 | 18.16 IU/L STANDARD_DEVIATION 5.92 |
| Glutamic pyruvic transaminase (GPT) | 24.25 IU/L STANDARD_DEVIATION 8.51 | 23.02 IU/L STANDARD_DEVIATION 10.6 | 20.93 IU/L STANDARD_DEVIATION 9.73 |
| Glycated hemoglobin A1c | 5.6 Percent of glycated hemoglobin STANDARD_DEVIATION 0.5 | 5.5 Percent of glycated hemoglobin STANDARD_DEVIATION 0.4 | 5.5 Percent of glycated hemoglobin STANDARD_DEVIATION 0.3 |
| High-density lipoprotein cholesterol (HDL-C) | 1.5 mmol/L STANDARD_DEVIATION 0.4 | 1.6 mmol/L STANDARD_DEVIATION 0.4 | 1.7 mmol/L STANDARD_DEVIATION 0.4 |
| Insulin sensitivity | 2.17 Unitless STANDARD_DEVIATION 0.71 | 2.07 Unitless STANDARD_DEVIATION 0.79 | 1.98 Unitless STANDARD_DEVIATION 0.88 |
| Low-density lipoprotein cholesterol (LDL-C) | 2.6 mmol/L STANDARD_DEVIATION 1.1 | 2.5 mmol/L STANDARD_DEVIATION 1.1 | 2.3 mmol/L STANDARD_DEVIATION 1 |
| Region of Enrollment Mexico | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 10 Participants | 25 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 0 Participants |
| Systolic blood pressure | 120 mmHg STANDARD_DEVIATION 6 | 117 mmHg STANDARD_DEVIATION 9 | 115 mmHg STANDARD_DEVIATION 11 |
| Total cholesterol | 4.9 mmol/L STANDARD_DEVIATION 1 | 4.7 mmol/L STANDARD_DEVIATION 0.8 | 4.5 mmol/L STANDARD_DEVIATION 0.6 |
| Total insulin secretion | 0.58 Unitless STANDARD_DEVIATION 0.21 | 0.65 Unitless STANDARD_DEVIATION 0.24 | 0.71 Unitless STANDARD_DEVIATION 0.25 |
| Triglycerides | 1.6 mmol/L STANDARD_DEVIATION 0.7 | 1.6 mmol/L STANDARD_DEVIATION 0.7 | 1.6 mmol/L STANDARD_DEVIATION 0.6 |
| Uric Acid | 0.32 mmol/L STANDARD_DEVIATION 0.06 | 0.3 mmol/L STANDARD_DEVIATION 0.05 | 0.29 mmol/L STANDARD_DEVIATION 0.05 |
| Very low-density lipoprotein (VLDL) | 0.77 mmol/L STANDARD_DEVIATION 0.36 | 0.75 mmol/L STANDARD_DEVIATION 0.4 | 0.72 mmol/L STANDARD_DEVIATION 0.3 |
| Waist circumference | 103 cm STANDARD_DEVIATION 7 | 105 cm STANDARD_DEVIATION 9 | 106 cm STANDARD_DEVIATION 10 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 15 | 2 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
2 Hours Plasma Glucose (2-h PG)
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.
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 2 Hours Plasma Glucose (2-h PG) | 9.0 mmol/L | Standard Deviation 0.8 |
| Chlorogenic Acid | 2 Hours Plasma Glucose (2-h PG) | 8.5 mmol/L | Standard Deviation 0.4 |
p-value: 0.084Wilcoxon (Mann-Whitney)
Primary
Fasting Plasma Glucose (FPG)
Reflect the fasting glucose level after a 10- to 12-h overnight fast.
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo | Fasting Plasma Glucose (FPG) | 5.8 mmol/L | Standard Deviation 0.3 |
| Chlorogenic Acid | Fasting Plasma Glucose (FPG) | 5.5 mmol/L | Standard Deviation 0.4 |
p-value: 0.004Wilcoxon (Mann-Whitney)
Primary
First Phase of Insulin Secretion
After intervention with Stumvoll index
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | First Phase of Insulin Secretion | 1281 Unitless | Standard Deviation 818 |
| Chlorogenic Acid | First Phase of Insulin Secretion | 1133 Unitless | Standard Deviation 601 |
p-value: 0.084Wilcoxon (Mann-Whitney)
Primary
Glycated Hemoglobin A1c (A1C)
Shows what a person's average blood glucose level was for the 2 to 3 months before the test high-performance.
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Glycated Hemoglobin A1c (A1C) | 5.8 Percentage of A1C | Standard Deviation 0.3 |
| Chlorogenic Acid | Glycated Hemoglobin A1c (A1C) | 5.5 Percentage of A1C | Standard Deviation 0.4 |
p-value: 0.755Wilcoxon (Mann-Whitney)
Primary
Insulin Sensitivity
After intervention Matsuda Index
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Insulin Sensitivity | 2.43 Unitless | Standard Deviation 0.88 |
| Chlorogenic Acid | Insulin Sensitivity | 2.30 Unitless | Standard Deviation 1.23 |
p-value: 0.004Wilcoxon (Mann-Whitney)
Primary
Total Insulin Secretion
After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Insulin Secretion | 0.55 Unitless | Standard Deviation 0.26 |
| Chlorogenic Acid | Total Insulin Secretion | 0.63 Unitless | Standard Deviation 0.25 |
p-value: 0.03Wilcoxon (Mann-Whitney)
Secondary
Area Under the Curve of Glucose
Area under the curve of glucose was obtained using the trapezoidal integration.
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Curve of Glucose | 1187 mmol/l/min | Standard Deviation 130 |
| Chlorogenic Acid | Area Under the Curve of Glucose | 1145 mmol/l/min | Standard Deviation 199 |
Secondary
Area Under the Curve of Insulin
Before and after intervention area under the curve of insulin
Time frame: Week 12.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Area Under the Curve of Insulin | 67,322 pmol/L/min |
| Chlorogenic Acid | Area Under the Curve of Insulin | 72,857 pmol/L/min |
p-value: 0.074Wilcoxon (Mann-Whitney)
Secondary
Body Mass Index
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
Time frame: Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Body Mass Index | 32.0 kg/m^2 | Standard Deviation 2.6 |
| Chlorogenic Acid | Body Mass Index | 31.4 kg/m^2 | Standard Deviation 2.7 |
p-value: 0.022Wilcoxon (Mann-Whitney)
Secondary
Body Weight
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
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Body Weight | 81.3 kg | Standard Deviation 7.9 |
| Chlorogenic Acid | Body Weight | 80.8 kg | Standard Deviation 11 |
p-value: 0.022Wilcoxon (Mann-Whitney)
Secondary
Creatinine
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
Time frame: Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Creatinine | 0.06 mmol/L | Standard Deviation 0.04 |
| Chlorogenic Acid | Creatinine | 0.06 mmol/L | Standard Deviation 0.02 |
p-value: 0.774Wilcoxon (Mann-Whitney)
Secondary
Diastolic Blood Plessure (DBP)
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
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Diastolic Blood Plessure (DBP) | 78 mmHg | Standard Deviation 7 |
| Chlorogenic Acid | Diastolic Blood Plessure (DBP) | 74 mmHg | Standard Deviation 10 |
p-value: 0.42Wilcoxon (Mann-Whitney)
Secondary
Glutamic Oxaloacetic Transaminase (GOT)
Before and after intervention by spectrophotometry
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Glutamic Oxaloacetic Transaminase (GOT) | 22.03 IU/L | Standard Deviation 10.91 |
| Chlorogenic Acid | Glutamic Oxaloacetic Transaminase (GOT) | 17.79 IU/L | Standard Deviation 8.73 |
p-value: 0.472Wilcoxon (Mann-Whitney)
Secondary
Glutamic Pyruvic Transaminase (GPT)
Before and after intervention by spectrophotometry
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Glutamic Pyruvic Transaminase (GPT) | 25.25 IU/L | Standard Deviation 13.46 |
| Chlorogenic Acid | Glutamic Pyruvic Transaminase (GPT) | 22.64 IU/L | Standard Deviation 15.71 |
p-value: 0.376Wilcoxon (Mann-Whitney)
Secondary
High-density Lipoprotein Cholesterol (HDL-C)
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
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | High-density Lipoprotein Cholesterol (HDL-C) | 1.5 mmol/L | Standard Deviation 0.3 |
| Chlorogenic Acid | High-density Lipoprotein Cholesterol (HDL-C) | 1.8 mmol/L | Standard Deviation 0.3 |
p-value: 0.059Wilcoxon (Mann-Whitney)
Secondary
Low-density Lipoprotein Cholesterol (LDL-C)
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
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Low-density Lipoprotein Cholesterol (LDL-C) | 2.7 mmol/L | Standard Deviation 0.8 |
| Chlorogenic Acid | Low-density Lipoprotein Cholesterol (LDL-C) | 1.9 mmol/L | Standard Deviation 0.5 |
p-value: 0.049Wilcoxon (Mann-Whitney)
Secondary
Systolic Blood Pressure (SBP)
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
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Systolic Blood Pressure (SBP) | 118 mmHg | Standard Deviation 9 |
| Chlorogenic Acid | Systolic Blood Pressure (SBP) | 113 mmHg | Standard Deviation 8 |
p-value: 0.594Wilcoxon (Mann-Whitney)
Secondary
Total Cholesterol (TC)
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
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Cholesterol (TC) | 5.3 mmol/L | Standard Deviation 0.9 |
| Chlorogenic Acid | Total Cholesterol (TC) | 4.3 mmol/L | Standard Deviation 0.5 |
p-value: 0.002Wilcoxon (Mann-Whitney)
Secondary
Triglycerides (TG)
The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Triglycerides (TG) | 1.7 mmol/L | Standard Deviation 0.7 |
| Chlorogenic Acid | Triglycerides (TG) | 1.3 mmol/L | Standard Deviation 0.5 |
p-value: 0.002Wilcoxon (Mann-Whitney)
Secondary
Uric Acid
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.
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Uric Acid | 0.34 mmol/l | Standard Deviation 0.06 |
| Chlorogenic Acid | Uric Acid | 0.30 mmol/l | Standard Deviation 0.09 |
p-value: 0.637Wilcoxon (Mann-Whitney)
Secondary
Very-low Density Lipoprotein (VLDL)
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
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Very-low Density Lipoprotein (VLDL) | 0.77 mmol/L | Standard Deviation 0.32 |
| Chlorogenic Acid | Very-low Density Lipoprotein (VLDL) | 0.61 mmol/L | Standard Deviation 0.22 |
p-value: 0.002Wilcoxon (Mann-Whitney)
Secondary
Waist Circumference (WC)
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
Time frame: Week 12.
Population: 3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Waist Circumference (WC) | 102 cm | Standard Deviation 5 |
| Chlorogenic Acid | Waist Circumference (WC) | 104 cm | Standard Deviation 10 |
p-value: 0.022Wilcoxon (Mann-Whitney)