Impaired Glucose TolerancePhase 2NCT02621060
Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance
A Phase 2 study testing Chlorogenic acid in people with Impaired Glucose Tolerance, run by University of Guadalajara at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- Chlorogenic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2015to Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340
About this study
Official title: 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.
Read the 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.
- Conditions
- Impaired Glucose Tolerance
- Being tested
- Placebo, Chlorogenic acid
- Keywords
- Chlorogenic acid, Control glucose, Insulin Secretion, Insulin Sensitivity
- Medical subject headings
- Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Calcined magnesia
Placebo: 1200 mg per day for three months
Chlorogenic acidDrug
Also called 3-O-Caffeoylquinic, acid Heriguard
Chologenic acid: 1200 mg per day for three months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days. Receives: Drug: Placebo |
| Chlorogenic acid | Experimental | 1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days. Receives: Drug: Chlorogenic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Plasma Glucose (FPG)
Reflect the fasting glucose level after a 10- to 12-h overnight fast.
Measured: 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.
Measured: 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.
Measured: Week 12.
Total Insulin Secretion
After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).
Measured: Week 12.
First Phase of Insulin Secretion
After intervention with Stumvoll index
Measured: Week 12.
Insulin Sensitivity
After intervention Matsuda Index
Measured: Week 12.
Secondary outcomes (16)
Area Under the Curve of Glucose
Area under the curve of glucose was obtained using the trapezoidal integration.
Measured: Week 12.
Area Under the Curve of Insulin
Before and after intervention area under the curve of insulin
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 12.
Glutamic Pyruvic Transaminase (GPT)
Before and after intervention by spectrophotometry
Measured: Week 12.
Glutamic Oxaloacetic Transaminase (GOT)
Before and after intervention by spectrophotometry
Measured: 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
Measured: 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.
Measured: Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esperanza Martínez-Abundis, University of Guadalajara
- Investigators
- Esperanza Martínez, PhD Science, Study director, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621060
- Sponsor's protocol ID
- CT-ACG-271281-LYZ
- Status last verified
- Jun 2019
- First submitted
- 1 Dec 2015
- Last updated
- 2 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 16551305Shaw 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.
PubMed 10097917Garber 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.
PubMed 18996826Whiting 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.
PubMed 22079683Garber 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.
PubMed 23598536Guerrero-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.
PubMed 18370832American 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.
PubMed 25897193Adeney 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.
PubMed 17364278McCarty 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.
PubMed 15694706Olthof 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.
PubMed 11208940Renouf 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.
PubMed 24039147Zhu H, Chen J, Dong X, Qin X, Li Z. Influence of dihydrocaffeic acid and quinic acid on lung metabolism and function: Implications for dietary interventions. Biochem Biophys Res Commun. 2025 Sep 1;777:152274. doi: 10.1016/j.bbrc.2025.152274. Epub 2025 Jun 28.
PubMed 40614321
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of Chlorogenic Acid on Glucemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance
- ClinicalTrials.gov ID
- NCT02621060
- Acronym / sponsor ID
- CT-ACG-271281-LYZ
- Conditions
- Impaired Glucose Tolerance
- Keywords
- Chlorogenic acid, Control glucose, Insulin Secretion, Insulin Sensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Posted 2 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days. |
| Chlorogenic acid | Experimental | Drug: Chlorogenic acid1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Calcined magnesiaPlacebo: 1200 mg per day for three months | Drug | Placebo |
| Chlorogenic acidAlso: 3-O-Caffeoylquinic, acid HeriguardChologenic acid: 1200 mg per day for three months | Drug | Chlorogenic acid |
Primary outcome
Fasting Plasma Glucose (FPG)
Time frame: Week 12.
Reflect the fasting glucose level after a 10- to 12-h overnight fast.
2 Hours Plasma Glucose (2-h PG)
Time frame: 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)
Time frame: 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
Time frame: Week 12.
After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).
First Phase of Insulin Secretion
Time frame: Week 12.
After intervention with Stumvoll index
Insulin Sensitivity
Time frame: Week 12.
After intervention Matsuda Index
16 secondary outcomes
Area Under the Curve of Glucose
Time frame: Week 12.
Area Under the Curve of Insulin
Time frame: Week 12.
Body Weight
Time frame: Week 12.
Body Mass Index
Time frame: Week 12.
Waist Circumference (WC)
Time frame: Week 12.
Systolic Blood Pressure (SBP)
Time frame: Week 12.
Diastolic Blood Plessure (DBP)
Time frame: Week 12.
Triglycerides (TG)
Time frame: Week 12.
Total Cholesterol (TC)
Time frame: Week 12.
High-density Lipoprotein Cholesterol (HDL-C)
Time frame: Week 12.
Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Week 12.
Very-low Density Lipoprotein (VLDL)
Time frame: Week 12.
Glutamic Pyruvic Transaminase (GPT)
Time frame: Week 12.
Glutamic Oxaloacetic Transaminase (GOT)
Time frame: Week 12.
Creatinine
Time frame: Week 12.
Uric Acid
Time frame: Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16551305van 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.
- Background: PubMed 10097917Shaw 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.
- Background: PubMed 18996826Garber 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.
- Background: PubMed 22079683Whiting 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.
- Background: PubMed 23598536Garber 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.
- Background: PubMed 18370832Guerrero-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.
- Background: PubMed 25897193American 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.
- Background: PubMed 17364278Adeney 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.
- Background: PubMed 15694706McCarty 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.
- Background: PubMed 11208940Olthof 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.
- Background: PubMed 24039147Renouf 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.
- Derived from this study: PubMed 40614321Zhu H, Chen J, Dong X, Qin X, Li Z. Influence of dihydrocaffeic acid and quinic acid on lung metabolism and function: Implications for dietary interventions. Biochem Biophys Res Commun. 2025 Sep 1;777:152274. doi: 10.1016/j.bbrc.2025.152274. Epub 2025 Jun 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esperanza Martínez, PhD Science study director
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chlorogenic acid in people with Impaired Glucose Tolerance, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Plasma Glucose (FPG) (time frame: Week 12.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02621060, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.