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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02253628
Other study ID # 340302
Secondary ID
Status Completed
Phase N/A
First received September 19, 2014
Last updated September 29, 2014
Start date February 2014
Est. completion date June 2014

Study information

Verified date September 2014
Source Agricultural University of Athens
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical 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 assessments in healthy individuals.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 55 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)


Intervention

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.
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.
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.
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Agricultural University of Athens Nestlé

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks No
Secondary 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. 4 weeks No
Secondary 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. 4 weeks No
Secondary 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. 4 weeks No
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