NCT02253628

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

September 19, 2014

Last Update Submit

September 29, 2014

Conditions

StressSigns and Symptoms, DigestiveBlood PressureIncreased Secretion of Gastrin

Keywords

CoffeeGastrinAlpha-amylaseCortisolSelf-reported gastrointestinal symptomsSelf-reported stressBlood pressure

Outcome Measures

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.

    4 weeks

Secondary Outcomes (3)

  • Blood pressure, energy intake and physical activity

    4 weeks

  • Salivary cortisol and alpha-amylase

    4 weeks

  • Self-reported sentiments, mood and stress.

    4 weeks

Study Arms (4)

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).

Other: Cold espressoOther: Hot instant coffeeOther: Cold instant coffeeOther: 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).

Other: Cold espressoOther: Hot instant coffeeOther: Cold instant coffeeOther: 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).

Other: Cold espressoOther: Hot instant coffeeOther: Cold instant coffeeOther: 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).

Other: Cold espressoOther: Hot instant coffeeOther: Cold instant coffeeOther: Hot filter coffee

Interventions

Cold espressoOTHER

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
Trial 1Trial 2Trial 3Trial 4
Hot instant coffeeOTHER

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
Trial 1Trial 2Trial 3Trial 4
Cold instant coffeeOTHER

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
Trial 1Trial 2Trial 3Trial 4
Hot filter coffeeOTHER

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
Trial 1Trial 2Trial 3Trial 4

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26979712DERIVED

MeSH Terms

Conditions

Signs and Symptoms, Digestive

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aimilia Papakonstantinou, PhD

    Agricultural University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Nutrition and Metabolism

Study Record Dates

First Submitted

September 19, 2014

First Posted

October 1, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 1, 2014

Record last verified: 2014-09