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

Blood Pressure Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02388672
• Other study ID #: GCB1
• Status: Withdrawn
• Phase: N/A
• First received: February 19, 2015
• Last updated: January 25, 2016
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Dietary Supplement:
• decaffeinated coffee
Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)
• chlorogenic acid
Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)
• green coffee bean extract supplement
Decaffeinated coffee together with green coffee bean extract supplement (560mg; high-CGA)
• placebo
Decaffeinated coffee with placebo capsules as control group for green coffee bean extract supplement (224mg; low-CGA)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure		from baseline to 30 min after intake of CGA	No
Secondary	heart rate		from baseline to 30 min after intake of CGA	No
Secondary	blood glucose		from baseline to 30 min after intake of CGA	No
Secondary	mood (Profile of Mood States (POMS) questionnaire)	Assessed with the Profile of Mood States (POMS) questionnaire	from baseline to 30 min after intake of CGA	No
Secondary	cognitive performance (parametric go/no-go task)	Assessed with a parametric go/no-go task measuring reaction times, attention (percentage of correct trials), and inhibition (percentage of correct inhibited trials)	from baseline to 30 min after intake of CGA	No