Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance

University of Guadalajara

Status and phase

Completed

Phase 2

Conditions

Impaired Glucose Tolerance

Treatments

Drug: Chlorogenic acid

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02621060

CT-ACG-271281-LYZ

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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.