Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance

Effect of the Administration of Chlorogenic Acid on Glucemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance

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.

Study Overview

• Status: Completed
• Conditions: Impaired Glucose Tolerance
• Intervention / Treatment: Drug: Placebo; Drug: Chlorogenic acid

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.	Drug: Placebo; Placebo: 1200 mg per day for three months; Other Names: Calcined magnesia
Experimental: Chlorogenic acid; 1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.	Drug: Chlorogenic acid; Chologenic acid: 1200 mg per day for three months; Other Names: 3-O-Caffeoylquinic, acid Heriguard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Plasma Glucose (FPG)	Reflect the fasting glucose level after a 10- to 12-h overnight fast.	Week 12.
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.	Week 12.
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.	Week 12.
Total Insulin Secretion	After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).	Week 12.
First Phase of Insulin Secretion	After intervention with Stumvoll index	Week 12.
Insulin Sensitivity	After intervention Matsuda Index	Week 12.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve of Glucose	Area under the curve of glucose was obtained using the trapezoidal integration.	Week 12.
Area Under the Curve of Insulin	Before and after intervention area under the curve of insulin	Week 12.
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	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	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	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	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	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	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	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	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	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	Week 12.
Glutamic Pyruvic Transaminase (GPT)	Before and after intervention by spectrophotometry	Week 12.
Glutamic Oxaloacetic Transaminase (GOT)	Before and after intervention by spectrophotometry	Week 12.
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	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.	Week 12.

Collaborators and Investigators

• Sponsor: University of Guadalajara
• Investigators: Study Director: Esperanza Martínez, PhD Science, University of Guadalajara

Publications and helpful links

General Publications

• Whiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011 Dec;94(3):311-21. doi: 10.1016/j.diabres.2011.10.029. Epub 2011 Nov 12.
• van Popele NM, Elizabeth Hak A, Mattace-Raso FU, Bots ML, van der Kuip DA, Reneman RS, Hoeks AP, Hofman A, Grobbee DE, Witteman JC. Impaired fasting glucose is associated with increased arterial stiffness in elderly people without diabetes mellitus: the Rotterdam Study. J Am Geriatr Soc. 2006 Mar;54(3):397-404. doi: 10.1111/j.1532-5415.2005.00614.x.
• Shaw JE, Zimmet PZ, de Courten M, Dowse GK, Chitson P, Gareeboo H, Hemraj F, Fareed D, Tuomilehto J, Alberti KG. Impaired fasting glucose or impaired glucose tolerance. What best predicts future diabetes in Mauritius? Diabetes Care. 1999 Mar;22(3):399-402. doi: 10.2337/diacare.22.3.399.
• Garber AJ, Handelsman Y, Einhorn D, Bergman DA, Bloomgarden ZT, Fonseca V, Garvey WT, Gavin JR 3rd, Grunberger G, Horton ES, Jellinger PS, Jones KL, Lebovitz H, Levy P, McGuire DK, Moghissi ES, Nesto RW. Diagnosis and management of prediabetes in the continuum of hyperglycemia: when do the risks of diabetes begin? A consensus statement from the American College of Endocrinology and the American Association of Clinical Endocrinologists. Endocr Pract. 2008 Oct;14(7):933-46. doi: 10.4158/EP.14.7.933. No abstract available.
• Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, Davidson MB, Einhorn D, Garvey WT, Grunberger G, Handelsman Y, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez G, Davidson MH; American Association of Clinical Endocrinologists. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013 Mar-Apr;19(2):327-36. doi: 10.4158/endp.19.2.a38267720403k242. No abstract available.
• Guerrero-Romero F, Rodriguez-Moran M, Perez-Fuentes R, Sanchez-Guillen MC, Gonzalez-Ortiz M, Martinez-Abundis E, Brito-Zurita O, Madero A, Figueroa B, Revilla-Monsalve C, Flores-Martinez SE, Islas-Andrade S, Rascon-Pacheco RA, Cruz M, Sanchez-Corona J. Prediabetes and its relationship with obesity in Mexican adults: The Mexican Diabetes Prevention (MexDiab) Study. Metab Syndr Relat Disord. 2008 Mar;6(1):15-23. doi: 10.1089/met.2007.0020.
• American Diabetes Association. Standards of medical care in diabetes-2015 abridged for primary care providers. Clin Diabetes. 2015 Apr;33(2):97-111. doi: 10.2337/diaclin.33.2.97. No abstract available.
• Adeney KL, Williams MA, Schiff MA, Qiu C, Sorensen TK. Coffee consumption and the risk of gestational diabetes mellitus. Acta Obstet Gynecol Scand. 2007;86(2):161-6. doi: 10.1080/00016340600994992.
• McCarty MF. A chlorogenic acid-induced increase in GLP-1 production may mediate the impact of heavy coffee consumption on diabetes risk. Med Hypotheses. 2005;64(4):848-53. doi: 10.1016/j.mehy.2004.03.037.
• Olthof MR, Hollman PC, Katan MB. Chlorogenic acid and caffeic acid are absorbed in humans. J Nutr. 2001 Jan;131(1):66-71. doi: 10.1093/jn/131.1.66.
• Renouf M, Marmet C, Giuffrida F, Lepage M, Barron D, Beaumont M, Williamson G, Dionisi F. Dose-response plasma appearance of coffee chlorogenic and phenolic acids in adults. Mol Nutr Food Res. 2014 Feb;58(2):301-9. doi: 10.1002/mnfr.201300349. Epub 2013 Sep 4.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: June 8, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Insulin Sensitivity; Insulin Secretion; Chlorogenic acid; Control glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Magnesium Oxide
• Other Study ID Numbers: CT-ACG-271281-LYZ