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Evaluation of Effects of Green Coffee Bean Extract (GCE) on Physiological and Psychological Variables

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ClinicalTrials.gov Identifier: NCT02388672
Recruitment Status : Withdrawn (Personnel changes)
First Posted : March 17, 2015
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Isabelle Mack, University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE February 19, 2015
First Posted Date  ICMJE March 17, 2015
Last Update Posted Date January 26, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2015)
blood pressure [ Time Frame: from baseline to 30 min after intake of CGA ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02388672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2015)
  • heart rate [ Time Frame: from baseline to 30 min after intake of CGA ]
  • blood glucose [ Time Frame: from baseline to 30 min after intake of CGA ]
  • mood (Profile of Mood States (POMS) questionnaire) [ Time Frame: from baseline to 30 min after intake of CGA ]
    Assessed with the Profile of Mood States (POMS) questionnaire
  • cognitive performance (parametric go/no-go task) [ Time Frame: from baseline to 30 min after intake of CGA ]
    Assessed with a parametric go/no-go task measuring reaction times, attention (percentage of correct trials), and inhibition (percentage of correct inhibited trials)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Effects of Green Coffee Bean Extract (GCE) on Physiological and Psychological Variables
Official Title  ICMJE Evaluation of Effects of Green Coffee Bean Extract (GCE) on Physiological and Psychological Variables- a Randomized, Placebo-controlled and Double-blinded Study in Healthy Subjects
Brief Summary

Coffee as one of the most favorite worldwide beverages comprises a variety of chemicals with health benefits. Most investigations have so far focused on the beneficial effects of caffeine but knowledge about non-caffeine coffee compounds such as chlorogenic acid (CGA) is scarce. The reducing risk of a variety of diseases following CGA consumption has been mentioned in recent basic and clinical studies. However, there is a lack of studies that examine the behavioral effects of CGA. This study aims to fill this gap.

In a randomized double-blind study, the investigators test the acute effects of coffee enriched with CGA or CGA supplement on physiological functions such as blood pressure, blood glucose, and heart rate, and on psychological functions such as mood and cognitive performance in 30 healthy adult subjects (18-40 years).

Participants will be allocated to an intervention plan using computer-generated random numbers. Treatments comprise of (1) 6g decaffeinated (5 mg caffeine) coffee (250 ml) with high total CGA (560 mg), or (2) 6g decaffeinated coffee (250 ml) with normal total CGA (224 mg), or (3) 6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee bean extract with total CGA (560mg), or (4) 6g decaffeinated coffee (250 ml) with normal total CGA and placebo, or (5) no treatment group. Upon arrival in the laboratory, participants will complete a 24-hour food recall, a psychometric test battery, and mood and cognitive performance tests. The tests will be repeated 40 min following CGA application, which coincide with the approximated peak of CGA blood concentrations and at 120 min post treatment. Blood pressure, blood glucose and heart rate recordings will be taken prior to treatment and at 1, 30, 60, 90 and 120 min post-treatment. The response to GCE-enriched coffee will be compared to GCE supplement for each of the groups of variables.

Detailed Description

Coffee as one of the most favorite worldwide beverages comprises a variety of chemicals maintaining the greatest health benefits among the commonly consumed beverages. Most investigations have so far focused on the beneficial effects of caffeine. On the contrary, knowledge on potential health benefits of non-caffeine coffee compounds is scarce. Coffee contains many polyphenols, especially chlorogenic acids (CGA), which have purported antioxidant abilities. With increasing incidence of degenerative diseases, the general public is turning to use natural herbal supplements, as one of these agents, CGA has been biologically and medically emphasized and can be expected to become a topic addressed in future studies, medical trends and pharmacology. The reducing risk of a variety of diseases following CGA consumption has been mentioned in recent basic and clinical studies. However, there is a lack of studies that examine the behavioral effects of CGA. This study aims to fill this gap.

In a randomized double-blind study, the investigators test the acute effects of coffee enriched with CGA or CGA supplement on physiological functions such as blood pressure, blood glucose, and heart rate, and on psychological functions such as mood and cognitive performance in 30 healthy adult subjects (18-40 years).

Participants will be allocated to an intervention plan using computer-generated random numbers. Treatments comprise of (1) 6g decaffeinated (5 mg caffeine) coffee (250 ml) with high total CGA (560 mg), or (2) 6g decaffeinated coffee (250 ml) with normal total CGA (224 mg) , or (3) 6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee bean extract with total CGA (560mg), or (4) 6g decaffeinated coffee (250 ml) with normal total CGA and placebo, or (5) no treatment group. Participants will be instructed to abstain from alcohol, foods, and beverages containing caffeine, chlorogenic acids and high polyphenol content for 24 hours prior to the experiment. Upon arrival in the laboratory, participants will complete a 24-hour food recall, a psychometric test battery consisting of the questionnaire on competence and control beliefs (FKK), the Life Orientation Test-Revised (LOT-R), the Beliefs about Medicines Questionnaire (BMQ), the Sensitivity to Punishment and Reward Questionnaire (SPSRQ), General Self-Efficacy (SWE) questionnaire, and mood and cognitive performance tests consisting of the Profile of Mood States (POMS) questionnaire, a parametric Go/no-Go test (PGNG) and the California Verbal Learning Test (CVLT). The POMS, Go/no-Go, and CVLT will be repeated 40 min following CGA application, which coincide with the approximated peak of CGA blood concentrations and at 120 min post treatment. Blood pressure, blood glucose and heart rate recordings will be taken prior to treatment and at 1, 30, 60, 90 and 120 min post-treatment. The response to GCE-enriched coffee will be compared to GCE supplement for each of the groups of variables.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Blood Pressure
Intervention  ICMJE
  • Dietary Supplement: decaffeinated coffee
    Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)
  • Dietary Supplement: chlorogenic acid
    Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)
  • Dietary Supplement: green coffee bean extract supplement
    Decaffeinated coffee together with green coffee bean extract supplement (560mg; high-CGA)
  • Dietary Supplement: placebo
    Decaffeinated coffee with placebo capsules as control group for green coffee bean extract supplement (224mg; low-CGA)
Study Arms  ICMJE
  • Experimental: Drink high-CGA
    Participants will drink once 250ml of decaffeinated coffee enriched with chlorogenic acid (CGA) (6g decaffeinated coffee (5 mg caffeine) with high total CGA (560 mg)).
    Interventions:
    • Dietary Supplement: decaffeinated coffee
    • Dietary Supplement: chlorogenic acid
  • Placebo Comparator: Drink low-CGA
    6g decaffeinated coffee (250 ml) with normal total CGA (224 mg)
    Interventions:
    • Dietary Supplement: decaffeinated coffee
    • Dietary Supplement: chlorogenic acid
  • Experimental: Capsules high-CGA
    6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee bean extract supplement with total CGA (560mg)
    Interventions:
    • Dietary Supplement: decaffeinated coffee
    • Dietary Supplement: chlorogenic acid
    • Dietary Supplement: green coffee bean extract supplement
  • Placebo Comparator: Capsules low-CGA
    6g decaffeinated coffee (250 ml) with normal total CGA and placebo
    Interventions:
    • Dietary Supplement: decaffeinated coffee
    • Dietary Supplement: chlorogenic acid
    • Dietary Supplement: placebo
  • No Intervention: Control
    No treatment control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 25, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2015)
30
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults between 18 and 40 years old
  • Normal weight (BMI > 18 and < 25 kg/m2)
  • Regular coffee drinkers (1 to 2 cups/day)
  • Both male and female

Exclusion Criteria:

  • BMI <18 or >25 kg/m2
  • Systolic blood pressure (SBP) <100 or >160 mmHg
  • Diastolic blood pressure (DBP) <50 or >100 mmHg
  • History of neurological, psychiatric, cardiac, endocrine or other disorders
  • History of substance abuse
  • Current use of antihypertensive and psychotropic medication
  • More than 30 g/day alcohol consumption
  • Woman who are pregnant or lactating
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02388672
Other Study ID Numbers  ICMJE GCB1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Isabelle Mack, University Hospital Tuebingen
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Isabelle Mack, Dr. University Hospital Tübingen
PRS Account University Hospital Tuebingen
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP