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CompletedNCT02253628Updated Oct 1, 2014

The Acute Effect of Coffee Consumption on Stomach, Self-reported Gastrointestinal Symptoms and Stress.

An interventional study of Cold espresso and Hot instant coffee in Stress, Signs and Symptoms, Digestive and Blood Pressure, sponsored by Agricultural University of Athens. Completed. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by Agricultural University of Athens · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stress
  • Signs and Symptoms, Digestive
  • Blood Pressure
  • Increased Secretion of Gastrin

Keywords

  • Coffee
  • Gastrin
  • Alpha-amylase
  • Cortisol
  • Self-reported gastrointestinal symptoms
  • Self-reported stress
  • Blood pressure
03

In context

Signs and Symptoms, Digestive

25 studies on the registry are indexed under Signs and Symptoms, Digestive; 1 is open to participants now.

This study's enrollment of 40 is below the median of 45 across 22 interventional studies indexed under Signs and Symptoms, Digestive.

Browse Signs and Symptoms, Digestive studies →

Lead sponsor

Agricultural University of Athens is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Stable body weight for at least 1 month prior to study enrollment.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Trial 1

    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).

    Other: Cold espresso · Other: Hot instant coffee · Other: Cold instant coffee · Other: Hot filter coffee

  • Experimental
    Trial 2

    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).

    Other: Cold espresso · Other: Hot instant coffee · Other: Cold instant coffee · Other: Hot filter coffee

  • Experimental
    Trial 3

    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).

    Other: Cold espresso · Other: Hot instant coffee · Other: Cold instant coffee · Other: Hot filter coffee

  • Experimental
    Trial 4

    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).

    Other: Cold espresso · Other: Hot instant coffee · Other: Cold instant coffee · Other: Hot filter coffee

Interventions

  • OtherCold espresso

    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.

    Also known as: Buondi prestige

  • OtherHot instant coffee

    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.

    Also known as: Nescafé Classic

  • OtherCold instant coffee

    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.

    Also known as: Nescafé Classic

  • OtherHot 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.

    Also known as: Nestlé Professional Plantage Filter Coffee

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

Secondary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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.

    Time frame: 4 weeks

  3. 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.

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2014, a primary completion of Jun 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2014
First posted
Oct 1, 2014
Start
Feb 2014
Primary completionActual
Jun 2014
CompletionActual
Jun 2014
Last update
Oct 1, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02253628
Lead sponsor
Agricultural University of Athens
Responsible party
Aimilia Papakonstantinou (Lecturer of Nutrition and Metabolism, Agricultural University of Athens) — Principal investigator
First posted
Oct 1, 2014
Start date
Feb 2014
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Oct 1, 2014

Study contacts

Aimilia Papakonstantinou, PhD
principal investigator · Agricultural University of Athens

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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