Influence of a Bitter Compound and Bittermasking Compound on Gastric pH

NCT ID: NCT02372188

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-04-30

Brief Summary

The purpose of this study is to elucidate whether bitter taste induced by the bitter compound caffeine and the reduction of bitter taste by addition of the bitter masking compound Homoeriodictyol sodium salt (HED) influence gastric acid secretion, subjective feelings of hunger, ad libitum food intake and satiating hormones in healthy volunteers.

Detailed Description

The influence of 125 mL water, 150 mg caffeine/125 mL water, 30 mg HED/125 mL water or the combination of 150 mg caffeine + 30 mg HED/125 mL water on the gastric pH on different test days was investigated. Prior to the intervention, the trial subjects had to fast from food and liquid for 10 h, except for 200 mL of tap water that were allowed during this time period. During the experiment, the subjects remained in a supine left-sided position.

For the non-invasive measurement of the gastric pH, the Heidelberg Detection System (Heidelberg Medical Inc., USA) was used which has been successfully used in our working group.

This system consists of a pH-sensitive capsule (called a Heidelberg capsule), with a length of 2 cm, that has to be swallowed and contains a miniature radio transmitter. This system allows the detection of the actual gastric pH of the volunteer over a specific time period [Liszt et al 2012, Rubach et al. 2014].

Prior to each test, Heidelberg capsules were activated for 5 min in a 0.9% sterile NaCl solution and calibrated using two calibration points, pH 1 and 7. Afterward, the subjects swallowed the capsule lay down on the left side. The capsule sends a signal to a transceiver, which has to be placed on the abdomen of the volunteer. The transceiver sends the signal to the recorder connected to a computer. The data can be collected and shown as a gastrogram on the computer screen, where the pH is drawn over time. When the intragastric pH was constant between pH 0.5 and 2.5 for at least 3 min, the capsule was considered to be in the stomach. Afterward, each trial started with the administration of 5 mL of a saturated sodium bicarbonate solution (NaHCO3). This alkaline challenge triggers a rise in gastric pH between around pH 6 to 7 and subsequently leads to the secretion of stomach acid by the parietal cells. The test solutions were administered 5 minutes after or 30 min before the alkaline challenge.

Reacidification time as well as the time until start of the reacidification has been analyzed.

Ratings of hunger were assessed before and after each gastric pH measurement by means of visual analog scales (VAS). Before and after each intervention blood samples were drawn to quantify satiety hormones (ghrelin, PYY, GLP-1, serotonin). Ad libitum energy and macronutrient intakes from a standardized breakfast served after each treatment were calculated.

Conditions

Change of Gastric pH

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Water

125 mL water are administered during or before gastric pH measurement

Group Type: EXPERIMENTAL

water

Intervention Type: OTHER

Control

Caffeine

150 mg Caffeine and 125 mL water are administered during or before gastric pH measurement

Group Type: EXPERIMENTAL

caffeine

Intervention Type: DIETARY_SUPPLEMENT

Caffeine + homoeriodictyol sodium salt

150 mg Caffeine + 30 mg homoeriodictyol sodium salt and 125 mL water are administered during or before gastric pH measurement

Group Type: EXPERIMENTAL

caffein + homoeriodictyol sodium salt

Intervention Type: DIETARY_SUPPLEMENT

homoeriodictyol sodium salt

30 mg homoeriodictyol sodium salt and 125 mL water are administered during the gastric pH measurement

Group Type: EXPERIMENTAL

homoeriodictyol sodium salt

Intervention Type: DIETARY_SUPPLEMENT

Interventions

water

Control

Intervention Type: OTHER

caffeine

Intervention Type: DIETARY_SUPPLEMENT

caffein + homoeriodictyol sodium salt

Intervention Type: DIETARY_SUPPLEMENT

homoeriodictyol sodium salt

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• good general state of health
• sensorically untrained
• BMI: 19 - 26 kg/m2

Exclusion Criteria

• gastro-intestinal disease or discomfort,
• metabolic diseases,
• H.pylori infection,
• smoking,
• increased sensibility towards caffeine,
• intake of antibiotics in the last 2 months,
• medication except for oral contraceptives,
• drug- or alcohol-abuse,
• heart disease, high blood pressure,
• pregnancy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Univ.-Prof. Dr. Veronika Somoza

Univ.-Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veronika Somoza, Prof. PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vienna

Locations

Christian Doppler Laboratory for Bioactive Aroma Compounds

Vienna, , Austria

Countries

Austria

References

Liszt KI, Walker J, Somoza V. Identification of organic acids in wine that stimulate mechanisms of gastric acid secretion. J Agric Food Chem. 2012 Jul 18;60(28):7022-30. doi: 10.1021/jf301941u. Epub 2012 Jul 5.

Reference Type: BACKGROUND

PMID: 22708700 (View on PubMed)

Rubach M, Lang R, Bytof G, Stiebitz H, Lantz I, Hofmann T, Somoza V. A dark brown roast coffee blend is less effective at stimulating gastric acid secretion in healthy volunteers compared to a medium roast market blend. Mol Nutr Food Res. 2014 Jun;58(6):1370-3. doi: 10.1002/mnfr.201300890. Epub 2014 Feb 8.

Reference Type: BACKGROUND

PMID: 24510512 (View on PubMed)

Other Identifiers

GAS-14

Identifier Type: -

Identifier Source: org_study_id