Phase 2
N=30
Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance
Impaired Glucose Tolerance
Bottom Line
View on ClinicalTrials.gov: NCT02621060 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Fasting Plasma Glucose (FPG) — 5.8; 5.5 mmol/L — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Chlorogenic acid (Drug)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Guadalajara
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Plasma Glucose (FPG) |
5.8; 5.5 | 0.004 sig |
| PRIMARY 2 Hours Plasma Glucose (2-h PG) |
9.0; 8.5 | 0.084 |
| PRIMARY Glycated Hemoglobin A1c (A1C) |
5.8; 5.5 | 0.755 |
| PRIMARY Total Insulin Secretion |
0.55; 0.63 | 0.03 sig |
| PRIMARY First Phase of Insulin Secretion |
1281; 1133 | 0.084 |
| PRIMARY Insulin Sensitivity |
2.43; 2.30 | 0.004 sig |
| SECONDARY Area Under the Curve of Glucose |
1187; 1145 | — |
| SECONDARY Area Under the Curve of Insulin |
67,322; 72,857 | 0.074 |
| SECONDARY Body Weight |
81.3; 80.8 | 0.022 sig |
| SECONDARY Body Mass Index |
32.0; 31.4 | 0.022 sig |
| SECONDARY Waist Circumference (WC) |
102; 104 | 0.022 sig |
| SECONDARY Systolic Blood Pressure (SBP) |
118; 113 | 0.594 |
| SECONDARY Diastolic Blood Plessure (DBP) |
78; 74 | 0.42 |
| SECONDARY Triglycerides (TG) |
1.7; 1.3 | 0.002 sig |
| SECONDARY Total Cholesterol (TC) |
5.3; 4.3 | 0.002 sig |
| SECONDARY High-density Lipoprotein Cholesterol (HDL-C) |
1.5; 1.8 | 0.059 |
| SECONDARY Low-density Lipoprotein Cholesterol (LDL-C) |
2.7; 1.9 | 0.049 sig |
| SECONDARY Very-low Density Lipoprotein (VLDL) |
0.77; 0.61 | 0.002 sig |
| SECONDARY Glutamic Pyruvic Transaminase (GPT) |
25.25; 22.64 | 0.376 |
| SECONDARY Glutamic Oxaloacetic Transaminase (GOT) |
22.03; 17.79 | 0.472 |
| SECONDARY Creatinine |
0.06; 0.06 | 0.774 |
| SECONDARY Uric Acid |
0.34; 0.30 | 0.637 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02621060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.