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

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ClinicalTrials.gov Identifier: NCT02253628
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Collaborator:
Nestlé
Information provided by (Responsible Party):
Aimilia Papakonstantinou, Agricultural University of Athens

Brief 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.

Condition or disease Intervention/treatment Phase
Stress Signs and Symptoms, Digestive Blood Pressure Increased Secretion of Gastrin Other: Cold espresso Other: Hot instant coffee Other: Cold instant coffee Other: Hot filter coffee Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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.
Study Start Date : February 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.
Other Name: Buondi prestige

Other: Hot 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.
Other Name: Nescafé Classic

Other: Cold 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.
Other Name: Nescafé Classic

Other: Hot 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.
Other Name: Nestlé Professional Plantage 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
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.
Other Name: Buondi prestige

Other: Hot 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.
Other Name: Nescafé Classic

Other: Cold 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.
Other Name: Nescafé Classic

Other: Hot 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.
Other Name: Nestlé Professional Plantage 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
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.
Other Name: Buondi prestige

Other: Hot 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.
Other Name: Nescafé Classic

Other: Cold 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.
Other Name: Nescafé Classic

Other: Hot 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.
Other Name: Nestlé Professional Plantage 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
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.
Other Name: Buondi prestige

Other: Hot 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.
Other Name: Nescafé Classic

Other: Cold 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.
Other Name: Nescafé Classic

Other: Hot 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.
Other Name: Nestlé Professional Plantage Filter Coffee




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Blood pressure, energy intake and physical activity [ Time Frame: 4 weeks ]
    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.

  2. Salivary cortisol and alpha-amylase [ 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 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.

  3. Self-reported sentiments, mood and stress. [ Time Frame: 4 weeks ]
    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.



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253628


Sponsors and Collaborators
Agricultural University of Athens
Nestlé
Investigators
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Principal Investigator: Aimilia Papakonstantinou, PhD Agricultural University of Athens

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aimilia Papakonstantinou, Lecturer of Nutrition and Metabolism, Agricultural University of Athens
ClinicalTrials.gov Identifier: NCT02253628     History of Changes
Other Study ID Numbers: 340302
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Keywords provided by Aimilia Papakonstantinou, Agricultural University of Athens:
Coffee
Gastrin
Alpha-amylase
Cortisol
Self-reported gastrointestinal symptoms
Self-reported stress
Blood pressure

Additional relevant MeSH terms:
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Signs and Symptoms
Signs and Symptoms, Digestive
Zollinger-Ellison Syndrome
Paraneoplastic Endocrine Syndromes
Paraneoplastic Syndromes
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Caffeine
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Gastrins
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Anti-Inflammatory Agents