Back to resultsEffect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance
Primary Purpose
Impaired Glucose Tolerance
Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Placebo
Chlorogenic acid
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Glucose Tolerance focused on measuring Chlorogenic acid, Control glucose, Insulin Secretion, Insulin Sensitivity
Eligibility Criteria
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.
Sites / Locations
- Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Chlorogenic acid
Arm Description
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Outcomes
Primary Outcome Measures
Fasting Plasma Glucose (FPG)
Reflect the fasting glucose level after a 10- to 12-h overnight fast.
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.
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.
Total Insulin Secretion
After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).
First Phase of Insulin Secretion
After intervention with Stumvoll index
Insulin Sensitivity
After intervention Matsuda Index
Secondary Outcome Measures
Area Under the Curve of Glucose
Area under the curve of glucose was obtained using the trapezoidal integration.
Area Under the Curve of Insulin
Before and after intervention area under the curve of insulin
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
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
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
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
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
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
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
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
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
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
Glutamic Pyruvic Transaminase (GPT)
Before and after intervention by spectrophotometry
Glutamic Oxaloacetic Transaminase (GOT)
Before and after intervention by spectrophotometry
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
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.
Full Information
NCT ID
NCT02621060
First Posted
December 1, 2015
Last Updated
June 8, 2019
Sponsor
University of Guadalajara
1. Study Identification
Unique Protocol Identification Number
NCT02621060
Brief Title
Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance
Official Title
Effect of the Administration of Chlorogenic Acid on Glucemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance
Keywords
Chlorogenic acid, Control glucose, Insulin Secretion, Insulin Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Arm Title
Chlorogenic acid
Arm Type
Experimental
Arm Description
1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Calcined magnesia
Intervention Description
Placebo: 1200 mg per day for three months
Intervention Type
Drug
Intervention Name(s)
Chlorogenic acid
Other Intervention Name(s)
3-O-Caffeoylquinic, acid Heriguard
Intervention Description
Chologenic acid: 1200 mg per day for three months
Primary Outcome Measure Information:
Title
Fasting Plasma Glucose (FPG)
Description
Reflect the fasting glucose level after a 10- to 12-h overnight fast.
Time Frame
Week 12.
Title
2 Hours Plasma Glucose (2-h PG)
Description
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.
Title
Glycated Hemoglobin A1c (A1C)
Description
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.
Title
Total Insulin Secretion
Description
After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).
Time Frame
Week 12.
Title
First Phase of Insulin Secretion
Description
After intervention with Stumvoll index
Time Frame
Week 12.
Title
Insulin Sensitivity
Description
After intervention Matsuda Index
Time Frame
Week 12.
Secondary Outcome Measure Information:
Title
Area Under the Curve of Glucose
Description
Area under the curve of glucose was obtained using the trapezoidal integration.
Time Frame
Week 12.
Title
Area Under the Curve of Insulin
Description
Before and after intervention area under the curve of insulin
Time Frame
Week 12.
Title
Body Weight
Description
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.
Title
Body Mass Index
Description
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.
Title
Waist Circumference (WC)
Description
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.
Title
Systolic Blood Pressure (SBP)
Description
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.
Title
Diastolic Blood Plessure (DBP)
Description
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.
Title
Triglycerides (TG)
Description
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.
Title
Total Cholesterol (TC)
Description
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.
Title
High-density Lipoprotein Cholesterol (HDL-C)
Description
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.
Title
Low-density Lipoprotein Cholesterol (LDL-C)
Description
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.
Title
Very-low Density Lipoprotein (VLDL)
Description
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.
Title
Glutamic Pyruvic Transaminase (GPT)
Description
Before and after intervention by spectrophotometry
Time Frame
Week 12.
Title
Glutamic Oxaloacetic Transaminase (GOT)
Description
Before and after intervention by spectrophotometry
Time Frame
Week 12.
Title
Creatinine
Description
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.
Title
Uric Acid
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esperanza Martínez, PhD Science
Organizational Affiliation
University of Guadalajara
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
12. IPD Sharing Statement
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16551305
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Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance
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