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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Chlorogenic Acids on the Human Vasculature

NCT03520452

Endothelial Dysfunction

COMPLETED NA

Neural Effects of Green Tea Extract on Dorsolateral Prefrontal Cortex

NCT01615289

Exploratory Behavior

COMPLETED NA

Green Coffee Extract and Metabolic Syndrome

NCT02764957

Metabolic Syndrome

COMPLETED PHASE2/PHASE3

Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation

NCT03265184

Metabolic Syndrome

COMPLETED NA

The Effect of Grape Seed Extract on Blood Pressure in People With Pre-Hypertension

NCT00979732

Hypertension

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)).

Group Type EXPERIMENTAL

decaffeinated coffee

Intervention Type DIETARY_SUPPLEMENT

Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)

chlorogenic acid

Intervention Type DIETARY_SUPPLEMENT

Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)

Drink low-CGA

6g decaffeinated coffee (250 ml) with normal total CGA (224 mg)

Group Type PLACEBO_COMPARATOR

decaffeinated coffee

Intervention Type DIETARY_SUPPLEMENT

Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)

chlorogenic acid

Intervention Type DIETARY_SUPPLEMENT

Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)

Capsules high-CGA

6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee bean extract supplement with total CGA (560mg)

Group Type EXPERIMENTAL

decaffeinated coffee

Intervention Type DIETARY_SUPPLEMENT

Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)

chlorogenic acid

Intervention Type DIETARY_SUPPLEMENT

Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)

green coffee bean extract supplement

Intervention Type DIETARY_SUPPLEMENT

Decaffeinated coffee together with green coffee bean extract supplement (560mg; high-CGA)

Capsules low-CGA

6g decaffeinated coffee (250 ml) with normal total CGA and placebo

Group Type PLACEBO_COMPARATOR

decaffeinated coffee

Intervention Type DIETARY_SUPPLEMENT

Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)

chlorogenic acid

Intervention Type DIETARY_SUPPLEMENT

Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)

placebo

Intervention Type DIETARY_SUPPLEMENT

Decaffeinated coffee with placebo capsules as control group for green coffee bean extract supplement (224mg; low-CGA)

Control

No treatment control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

decaffeinated coffee

Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)

Intervention Type DIETARY_SUPPLEMENT

chlorogenic acid

Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)

Intervention Type DIETARY_SUPPLEMENT

green coffee bean extract supplement

Decaffeinated coffee together with green coffee bean extract supplement (560mg; high-CGA)

Intervention Type DIETARY_SUPPLEMENT

placebo

Decaffeinated coffee with placebo capsules as control group for green coffee bean extract supplement (224mg; low-CGA)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes