StressNCT02253628
The Acute Effect of Coffee Consumption on Stomach, Self-reported Gastrointestinal Symptoms and Stress.
A study testing Cold espresso, Hot instant coffee and Cold instant coffee in people with Stress and Signs and Symptoms, Digestive, run by Agricultural University of Athens.
Trial summary
This study investigated the acute effect of the consumption of four different kinds of coffee (hot and cold instant coffee, cold espresso and hot filter coffee) with the same caffeine content on salivary gastrin, cortisol and alpha-amylase concentrations, on self-reported gastrointestinal symptoms and on psychometric… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Signs and Symptoms, Digestive, Blood Pressure
- What is being tested?
- Cold espresso, Hot instant coffee and Cold instant coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jun 2014
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Stable body weight for at least 1 month prior to study enrollment.
Who cannot join
- If one volunteer consumed breakfast more than three days a week, their daily caffeine intake was over 500 mg caffeine, was taking medication, their psychological state was strongly influenced by some exogenous factor (e.g. moving to a new house, new job, divorce e.t.c.), was on hypocaloric diet for weight loss, was smoking more than five cigarettes a day, was an athlete with very vigorous physical activity (> 4 hours vigorous exercise a day), had a history of gastrointestinal disorders (e.g. gastroesophageal reflux disease (GERD), irritable bowel syndrome, diarrhea, ulcers e.t.c.), depression, diabetes, kidney disease, hypertension, blood disorders, liver disease, unregulated hyper - or hypothyroidism, arrhythmia, heart disease, cancer, vascular disease, recent surgery, or severe psychiatric disorders was automatically excluded from the study.
About this study
Official title: The Acute Effect of Coffee Consumption on Salivary Gastrin, Alpha-amylase and Cortisol Concentrations, on Self-reported Gastrointestinal Symptoms, on Self-reported Psychometric Assessments and on Blood Pressure.
This study investigated the acute effect of the consumption of four different kinds of coffee (hot and cold instant coffee, cold espresso and hot filter coffee) with the same caffeine content on salivary gastrin, cortisol and alpha-amylase concentrations, on self-reported gastrointestinal symptoms and on psychometric assessments in healthy individuals.
Read the detailed description
Coffee consumption is very common in Greece. Many of the consumers support that certain types of coffee and especially instant coffee cause gastrointestinal symptoms in healthy individuals. Up to now, few studies have investigated the relationship between coffee consumption, gastrointestinal symptoms and stress in healthy individuals with conflicting results.Coffee consumption is related with increased gastric acid and gastrin secretion, however it does not seem to affect stomach or stomach walls. Stress, which characterizes modern lifestyle, also is found to increase gastric acid and gastrin secretion and seems to be exclusively responsible for gastrointestinal symptoms.
- Being tested
- Cold espresso, Hot instant coffee, Cold instant coffee, Hot filter coffee
- Keywords
- Coffee, Gastrin, Alpha-amylase, Cortisol, Self-reported gastrointestinal symptoms, Self-reported stress, Blood pressure
- Medical subject headings
- Signs and Symptoms, Digestive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold espressoOther
Also called Buondi prestige
Volunteers consumed cold espresso with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
Hot instant coffeeOther
Also called Nescafé Classic
Volunteers consumed hot instant coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
Cold instant coffeeOther
Also called Nescafé Classic
Volunteers consumed cold instant coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
Hot filter coffeeOther
Also called Nestlé Professional Plantage Filter Coffee
Volunteers consumed hot filter coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
| Study group | Role | What they receive |
|---|---|---|
| Trial 1 | Experimental | Forty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee). Receives: Other: Cold espresso; Other: Hot instant coffee; Other: Cold instant coffee; Other: Hot filter coffee |
| Trial 2 | Experimental | Forty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee). Receives: Other: Cold espresso; Other: Hot instant coffee; Other: Cold instant coffee; Other: Hot filter coffee |
| Trial 3 | Experimental | Forty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee). Receives: Other: Cold espresso; Other: Hot instant coffee; Other: Cold instant coffee; Other: Hot filter coffee |
| Trial 4 | Experimental | Forty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee). Receives: Other: Cold espresso; Other: Hot instant coffee; Other: Cold instant coffee; Other: Hot filter coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary gastrin and self-reported gastrointestinal symptoms
The volunteers visited the lab after an 8-hour fasting. Saliva samples were taken at fasting for the determination of fasting salivary gastrin. After the consumption of coffee, saliva samples were taken at 15, 30, 60' for the determination of gastrin. Saliva samples were collected by the method "Salivette". Saliva was carried out by chewing a swab for about 1 minute. Then, the swab was returned to the Salivette and the container was centrifuged and saliva sample was obtained. The samples were stored at - 20 degrees of Celsius. Gastrin was determined by an immunoenzymatic method. In order to record the effects of coffee consumption on gastrointestinal symptoms, the participants completed a visual analogue scale every time saliva samples were collected (time 0', 15', 30', 60', 120', 180'). The visual analogue scale (1 = not at all to 10 = very) included 12 questions about gastrointestinal symptoms.
Measured: 4 weeks
Secondary outcomes (3)
Blood pressure, energy intake and physical activity
The aim was to investigate if blood pressure, energy intake and physical activity changed during the intervention. Blood pressure was measured three times in a sitting position after 15 minutes of rest by a mercury sphygmomanometer at the beginning and ending of each trial respectively. There was a 2-minute interval between measurements. Then, the average blood pressure measurements were calculated. Dietary intake was analyzed by Diet Analysis Plus (version 6.1). The database was extensively modified to include new foods and recipes. Physical activity was estimated by using metabolic equivalents of different activities performed by the volunteers the previous 7 days. Then, mean daily energy expenditure was estimated.
Measured: 4 weeks
Salivary cortisol and alpha-amylase
The volunteers visited the lab after an 8-hour fasting. Saliva samples were taken at fasting for the determination of fasting salivary cortisol and alpha-amylase. After the consumption of coffee, saliva samples were taken at 15, 30, 60' for the determination of alpha-amylase and at 60, 120, 180' for cortisol determination.Saliva samples were collected by the method "Salivette". Saliva was carried out by chewing a swab for about 1 minute. Then, the swab was returned to the Salivette and the container was centrifuged and saliva sample was obtained. The samples were stored at - 20 degrees of Celsius. Cortisol was determined by an immunoenzymatic method. Alpha-amylase was determined by a kinetic enzyme assay kit.
Measured: 4 weeks
Self-reported sentiments, mood and stress.
In order to record the effects of coffee consumption on stress and on sentiments and mood the participants completed the Zung self-assessment anxiety scale and a visual analogue scale every time saliva samples were collected (time 0', 15', 30', 60', 120', 180'). The Zung self-assessment anxiety scale included 20 questions, which were designed to assess how the volunteers felt the moment completing the questionnaire. The visual analogue scale (1 = not at all to 10 = very) included 17 questions about stress, sentiments and mood.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agricultural University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Principal investigator, Aimilia Papakonstantinou, Agricultural University of Athens
- Investigators
- Aimilia Papakonstantinou, PhD, Principal investigator, Agricultural University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253628
- Sponsor's protocol ID
- 340302
- Status last verified
- Sep 2014
- First submitted
- 19 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Papakonstantinou E, Kechribari I, Sotirakoglou Kappa, Tarantilis P, Gourdomichali T, Michas G, Kravvariti V, Voumvourakis K, Zampelas A. Acute effects of coffee consumption on self-reported gastrointestinal symptoms, blood pressure and stress indices in healthy individuals. Nutr J. 2016 Mar 15;15:26. doi: 10.1186/s12937-016-0146-0.
PubMed 26979712
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Coffee Consumption on Salivary Gastrin, Alpha-amylase and Cortisol Concentrations, on Self-reported Gastrointestinal Symptoms, on Self-reported Psychometric Assessments and on Blood Pressure.
- ClinicalTrials.gov ID
- NCT02253628
- Acronym / sponsor ID
- 340302
- Keywords
- Coffee, Gastrin, Alpha-amylase, Cortisol, Self-reported gastrointestinal symptoms, Self-reported stress, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Oct 2014 (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.
This study investigated the acute effect of the consumption of four different kinds of coffee (hot and cold instant coffee, cold espresso and hot filter coffee) with the same caffeine content on salivary gastrin, cortisol and alpha-amylase concentrations, on self-reported gastrointestinal symptoms and on psychometric assessments in healthy individuals.
Detailed description
Coffee consumption is very common in Greece. Many of the consumers support that certain types of coffee and especially instant coffee cause gastrointestinal symptoms in healthy individuals. Up to now, few studies have investigated the relationship between coffee consumption, gastrointestinal symptoms and stress in healthy individuals with conflicting results.Coffee consumption is related with increased gastric acid and gastrin secretion, however it does not seem to affect stomach or stomach walls. Stress, which characterizes modern lifestyle, also is found to increase gastric acid and gastrin secretion and seems to be exclusively responsible for gastrointestinal symptoms.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Trial 1 | Experimental | Other: Cold espresso, Other: Hot instant coffee, Other: Cold instant coffee, Other: Hot filter coffeeForty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee). |
| Trial 2 | Experimental | Other: Cold espresso, Other: Hot instant coffee, Other: Cold instant coffee, Other: Hot filter coffeeForty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee). |
| Trial 3 | Experimental | Other: Cold espresso, Other: Hot instant coffee, Other: Cold instant coffee, Other: Hot filter coffeeForty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee). |
| Trial 4 | Experimental | Other: Cold espresso, Other: Hot instant coffee, Other: Cold instant coffee, Other: Hot filter coffeeForty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee). |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Stable body weight for at least 1 month prior to study enrollment.
Key exclusion criteria (1 listed)
- If one volunteer consumed breakfast more than three days a week, their daily caffeine intake was over 500 mg caffeine, was taking medication, their psychological state was strongly influenced by some exogenous factor (e.g. moving to a new house, new job, divorce e.t.c.), was on hypocaloric diet for weight loss, was smoking more than five cigarettes a day, was an athlete with very vigorous physical activity (> 4 hours vigorous exercise a day), had a history of gastrointestinal disorders (e.g. gastroesophageal reflux disease (GERD), irritable bowel syndrome, diarrhea, ulcers e.t.c.), depression, diabetes, kidney disease, hypertension, blood disorders, liver disease, unregulated hyper - or hypothyroidism, arrhythmia, heart disease, cancer, vascular disease, recent surgery, or severe psychiatric disorders was automatically excluded from the study.
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 |
|---|---|---|
| Cold espressoAlso: Buondi prestigeVolunteers consumed cold espresso with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially. | Other | Trial 1, Trial 2, Trial 3, Trial 4 |
| Hot instant coffeeAlso: Nescafé ClassicVolunteers consumed hot instant coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially. | Other | Trial 1, Trial 2, Trial 3, Trial 4 |
| Cold instant coffeeAlso: Nescafé ClassicVolunteers consumed cold instant coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially. | Other | Trial 1, Trial 2, Trial 3, Trial 4 |
| Hot filter coffeeAlso: Nestlé Professional Plantage Filter CoffeeVolunteers consumed hot filter coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially. | Other | Trial 1, Trial 2, Trial 3, Trial 4 |
Primary outcome
Salivary gastrin and self-reported gastrointestinal symptoms
Time frame: 4 weeks
The volunteers visited the lab after an 8-hour fasting. Saliva samples were taken at fasting for the determination of fasting salivary gastrin. After the consumption of coffee, saliva samples were taken at 15, 30, 60' for the determination of gastrin. Saliva samples were collected by the method "Salivette". Saliva was carried out by chewing a swab for about 1 minute. Then, the swab was returned to the Salivette and the container was centrifuged and saliva sample was obtained. The samples were stored at - 20 degrees of Celsius. Gastrin was determined by an immunoenzymatic method. In order to record the effects of coffee consumption on gastrointestinal symptoms, the participants completed a visual analogue scale every time saliva samples were collected (time 0', 15', 30', 60', 120', 180'). The visual analogue scale (1 = not at all to 10 = very) included 12 questions about gastrointestinal symptoms.
3 secondary outcomes
Blood pressure, energy intake and physical activity
Time frame: 4 weeks
Salivary cortisol and alpha-amylase
Time frame: 4 weeks
Self-reported sentiments, mood and stress.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- Derived from this study: PubMed 26979712Papakonstantinou E, Kechribari I, Sotirakoglou Kappa, Tarantilis P, Gourdomichali T, Michas G, Kravvariti V, Voumvourakis K, Zampelas A. Acute effects of coffee consumption on self-reported gastrointestinal symptoms, blood pressure and stress indices in healthy individuals. Nutr J. 2016 Mar 15;15:26. doi: 10.1186/s12937-016-0146-0.
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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.
Aimilia Papakonstantinou, PhD principal investigator
Agricultural University of Athens
Questions about this trial
What is this clinical trial studying?
A study testing Cold espresso, Hot instant coffee and Cold instant coffee in people with Stress and Signs and Symptoms, Digestive, run by Agricultural University of Athens.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Oct 2014. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Salivary gastrin and self-reported gastrointestinal symptoms (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02253628, which also lists 1 linked publication.
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 1 Oct 2014.