Blood PressureNCT02388672
Evaluation of Effects of Green Coffee Bean Extract (GCE) on Physiological and Psychological Variables
A study testing decaffeinated coffee, chlorogenic acid and green coffee bean extract supplement in people with Blood Pressure, run by University Hospital Tuebingen.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- decaffeinated coffee, chlorogenic acid and green coffee bean extract supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Blood Pressure
- Being tested
- decaffeinated coffee, chlorogenic acid, green coffee bean extract supplement, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decaffeinated coffeeDietary supplement
Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)
chlorogenic acidDietary supplement
Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)
green coffee bean extract supplementDietary supplement
Decaffeinated coffee together with green coffee bean extract supplement (560mg; high-CGA)
placeboDietary supplement
Decaffeinated coffee with placebo capsules as control group for green coffee bean extract supplement (224mg; low-CGA)
| Study group | Role | What they receive |
|---|---|---|
| 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)). Receives: Dietary Supplement: decaffeinated coffee; Dietary Supplement: chlorogenic acid |
| Drink low-CGA | Placebo comparator | 6g decaffeinated coffee (250 ml) with normal total CGA (224 mg) Receives: 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) Receives: 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 Receives: Dietary Supplement: decaffeinated coffee; Dietary Supplement: chlorogenic acid; Dietary Supplement: placebo |
| Control | No intervention | No treatment control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Measured: from baseline to 30 min after intake of CGA
Secondary outcomes (4)
heart rate
Measured: from baseline to 30 min after intake of CGA
blood glucose
Measured: from baseline to 30 min after intake of CGA
mood (Profile of Mood States (POMS) questionnaire)
Assessed with the Profile of Mood States (POMS) questionnaire
Measured: from baseline to 30 min after intake of CGA
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)
Measured: from baseline to 30 min after intake of CGA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Personnel changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Isabelle Mack, University Hospital Tuebingen
- Investigators
- Isabelle Mack, Dr., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388672
- Sponsor's protocol ID
- GCB1
- Status last verified
- Jan 2016
- First submitted
- 19 Feb 2015
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02388672
- Acronym / sponsor ID
- GCB1
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Personnel changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Drink high-CGA | Experimental | Dietary Supplement: decaffeinated coffee, Dietary Supplement: chlorogenic acidParticipants will drink once 250ml of decaffeinated coffee enriched with chlorogenic acid (CGA) (6g decaffeinated coffee (5 mg caffeine) with high total CGA (560 mg)). |
| Drink low-CGA | Placebo comparator | Dietary Supplement: decaffeinated coffee, Dietary Supplement: chlorogenic acid6g decaffeinated coffee (250 ml) with normal total CGA (224 mg) |
| Capsules high-CGA | Experimental | Dietary Supplement: decaffeinated coffee, Dietary Supplement: chlorogenic acid, Dietary Supplement: green coffee bean extract supplement6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee bean extract supplement with total CGA (560mg) |
| Capsules low-CGA | Placebo comparator | Dietary Supplement: decaffeinated coffee, Dietary Supplement: chlorogenic acid, Dietary Supplement: placebo6g decaffeinated coffee (250 ml) with normal total CGA and placebo |
| Control | No intervention | –No treatment control group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decaffeinated coffeeDecaffeinated coffee with low chlorogenic acid (224mg; low-CGA) | Dietary supplement | Capsules high-CGA, Capsules low-CGA, Drink high-CGA, Drink low-CGA |
| chlorogenic acidDecaffeinated coffee with high chlorogenic acid (560mg; high-CGA) | Dietary supplement | Capsules high-CGA, Capsules low-CGA, Drink high-CGA, Drink low-CGA |
| green coffee bean extract supplementDecaffeinated coffee together with green coffee bean extract supplement (560mg; high-CGA) | Dietary supplement | Capsules high-CGA |
| placeboDecaffeinated coffee with placebo capsules as control group for green coffee bean extract supplement (224mg; low-CGA) | Dietary supplement | Capsules low-CGA |
Primary outcome
blood pressure
Time frame: from baseline to 30 min after intake of CGA
4 secondary outcomes
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
cognitive performance (parametric go/no-go task)
Time frame: from baseline to 30 min after intake of CGA
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Mack, Dr. principal investigator
University Hospital Tuebingen
Questions about this trial
What is this clinical trial studying?
A study testing decaffeinated coffee, chlorogenic acid and green coffee bean extract supplement in people with Blood Pressure, run by University Hospital Tuebingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: from baseline to 30 min after intake of CGA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.