NCT02621060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

August 2, 2019

Completed
Last Updated

August 2, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

December 1, 2015

Results QC Date

January 23, 2018

Last Update Submit

June 8, 2019

Conditions

Impaired Glucose Tolerance

Keywords

Chlorogenic acidControl glucoseInsulin SecretionInsulin Sensitivity

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (16)

  • Area Under the Curve of Glucose

    Week 12.

  • Area Under the Curve of Insulin

    Week 12.

  • Body Weight

    Week 12.

  • Body Mass Index

    Week 12.

  • Waist Circumference (WC)

    Week 12.

  • +11 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.

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.

Drug: Chlorogenic acid

Interventions

PlaceboDRUG

Placebo: 1200 mg per day for three months

Also known as: Calcined magnesia
Placebo
Chlorogenic acidDRUG

Chologenic acid: 1200 mg per day for three months

Also known as: 3-O-Caffeoylquinic, acid Heriguard
Chlorogenic acid

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (11)

  • 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.

    PMID: 16551305BACKGROUND

  • 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.

    PMID: 10097917BACKGROUND

  • 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.

    PMID: 18996826BACKGROUND

  • 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.

    PMID: 22079683BACKGROUND

  • 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.

    PMID: 23598536BACKGROUND

  • 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.

    PMID: 18370832BACKGROUND

  • 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.

    PMID: 25897193BACKGROUND

  • 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.

    PMID: 17364278BACKGROUND

  • 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.

    PMID: 15694706BACKGROUND

  • 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.

    PMID: 11208940BACKGROUND

  • 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.

    PMID: 24039147BACKGROUND

MeSH Terms

Conditions

Glucose IntoleranceInsulin Resistance

Interventions

Chlorogenic Acid

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

CinnamatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCyclohexanecarboxylic Acids

Results Point of Contact

Title
Dra. Esperanza Martínez Abundis
Organization
Institute of Experimental and Clinical Therapeutics
esperanzamartnezabundi@yahoo.com
+52-33-10-58-52-00

Study Officials

  • Esperanza Martínez, PhD Science

    University of Guadalajara

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher Professor

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 3, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

August 2, 2019

Results First Posted

August 2, 2019

Record last verified: 2019-06

Locations

ME(1)