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

This study has been withdrawn prior to enrollment.
(Personnel changes)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02388672
First Posted: March 17, 2015
Last Update Posted: January 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Isabelle Mack, University Hospital Tuebingen
  Purpose

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.


Condition Intervention
Blood Pressure Dietary Supplement: decaffeinated coffee Dietary Supplement: chlorogenic acid Dietary Supplement: green coffee bean extract supplement Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Dr. Isabelle Mack, University Hospital Tuebingen:

Primary Outcome Measures:
  • blood pressure [ Time Frame: from baseline to 30 min after intake of CGA ]

Secondary Outcome Measures:
  • 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)


Enrollment: 0
Study Start Date: March 2015
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)).
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)
Placebo Comparator: Drink low-CGA
6g decaffeinated coffee (250 ml) with normal total CGA (224 mg)
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)
Experimental: Capsules high-CGA
6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee bean extract supplement with total CGA (560mg)
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)
Placebo Comparator: Capsules low-CGA
6g decaffeinated coffee (250 ml) with normal total CGA and placebo
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: placebo
Decaffeinated coffee with placebo capsules as control group for green coffee bean extract supplement (224mg; low-CGA)
No Intervention: Control
No treatment control group

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388672


Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Isabelle Mack, Dr. University Hospital Tübingen
  More Information

Responsible Party: Dr. Isabelle Mack, Dr., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02388672     History of Changes
Other Study ID Numbers: GCB1
First Submitted: February 19, 2015
First Posted: March 17, 2015
Last Update Posted: January 26, 2016
Last Verified: January 2016