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

NCT02388672 | Withdrawn

• 1 other identifier: GCB1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• blood pressure

  from baseline to 30 min after intake of CGA

Secondary Outcomes (4)

• heart rate

  from baseline to 30 min after intake of CGA

• blood glucose

  from baseline to 30 min after intake of CGA

• mood (Profile of Mood States (POMS) questionnaire)

  from baseline to 30 min after intake of CGA

• cognitive performance (parametric go/no-go task)

  from baseline to 30 min after intake of CGA

Study Arms (5)

Drink high-CGA

EXPERIMENTAL

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; Dietary Supplement: chlorogenic acid

Drink low-CGA

PLACEBO COMPARATOR

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

Dietary Supplement: decaffeinated coffee; Dietary Supplement: chlorogenic acid

Capsules high-CGA

EXPERIMENTAL

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

Dietary Supplement: decaffeinated coffee; Dietary Supplement: chlorogenic acid; Dietary Supplement: green coffee bean extract supplement

Capsules low-CGA

PLACEBO COMPARATOR

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

Dietary Supplement: decaffeinated coffee; Dietary Supplement: chlorogenic acid; Dietary Supplement: placebo

Control

NO INTERVENTION

No treatment control group

Interventions

decaffeinated coffee DIETARY_SUPPLEMENT

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

Capsules high-CGA; Capsules low-CGA; Drink high-CGA; Drink low-CGA

chlorogenic acid DIETARY_SUPPLEMENT

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

Capsules high-CGA; Capsules low-CGA; Drink high-CGA; Drink low-CGA

green coffee bean extract supplement DIETARY_SUPPLEMENT

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

Capsules high-CGA

placebo DIETARY_SUPPLEMENT

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

Capsules low-CGA

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

MeSH Terms

Interventions

Chlorogenic Acid

Intervention Hierarchy (Ancestors)

Cinnamates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Cyclohexanecarboxylic Acids

Study Officials

• Isabelle Mack, Dr.

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 26, 2016

Record last verified: 2016-01