Change of Gastric pHNCT02372188
Influence of a Bitter Compound and Bittermasking Compound on Gastric pH
A study testing water, caffeine and caffein + homoeriodictyol sodium salt in people with Change of Gastric pH, run by University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Change of Gastric pH
- What is being tested?
- water, caffeine and caffein + homoeriodictyol sodium salt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good general state of health
- sensorically untrained
- BMI: 19 - 26 kg/m2
Who cannot join
- gastro-intestinal disease or discomfort,
- metabolic diseases,
- H.pylori infection,
- smoking,
- increased sensibility towards caffeine,
- intake of antibiotics in the last 2 months,
Show all 10Show fewer
- medication except for oral contraceptives,
- drug- or alcohol-abuse,
- heart disease, high blood pressure,
- pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Christian Doppler Laboratory for Bioactive Aroma Compounds
Vienna, 1090
About this study
Official title: Effect of Caffeine With and Without a Bitter Masking Compound on Gastric pH, Taking Into Account the Effect on Satiety Hormones in Blood Plasma and on Food Intake
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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waterOther
Control
caffeineDietary supplement
caffein + homoeriodictyol sodium saltDietary supplement
homoeriodictyol sodium saltDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Water | Experimental | 125 mL water are administered during or before gastric pH measurement Receives: Other: water |
| Caffeine | Experimental | 150 mg Caffeine and 125 mL water are administered during or before gastric pH measurement Receives: Dietary Supplement: caffeine |
| Caffeine + homoeriodictyol sodium salt | Experimental | 150 mg Caffeine + 30 mg homoeriodictyol sodium salt and 125 mL water are administered during or before gastric pH measurement Receives: Dietary Supplement: caffein + homoeriodictyol sodium salt |
| homoeriodictyol sodium salt | Experimental | 30 mg homoeriodictyol sodium salt and 125 mL water are administered during the gastric pH measurement Receives: Dietary Supplement: homoeriodictyol sodium salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the intragastral pH determined by the Heidelberg Detection system
Measured: recorded over a time period from 1 - 60 min
Secondary outcomes (3)
Change of plasma levels of Serotonin, Ghrelin, PYY and GLP-1
higher plasma levels of serotonin, PYY and GLP-1 are a satiety signal while higher levels of Ghrelin, Hunger-stimulating hormone, indicate appetite
Measured: Plasma are taken at two time points before and after the gastric pH measurement during a time period between 15 - 60 min
Food intake
A weighed standard breakfast will be served and ad libitum energy intake will be assessed by weighing the left overs of the breakfast and analyzed by nutrient data base. Total caloric intake [kcal], as well as the total carbohydrate [g], protein [g] and fat [g] intake will be analyzed.
Measured: after the gastric pH measurement on each testing day the subjects are served an ad libitum breakfast, and they have an open time frame how long they want to eat, max. 1 hour is anticipated
subjective feelings of hunger are recorded by means of visual analog scales (VAS)
The volunteers have to make a sign on a 10 cm long scale (visual analog scale), ranging from 0 (not hungry) to 10 (very hungry). The volunteer can make the sign at any point of the scale and we will measure the distance from the beginning until the sign [cm].
Measured: subjects are asked to fill the VAS out immediately before and after the gastric pH measurement, max. 2 min is anticipated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startSep 2013
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Change of Gastric pHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ.-Prof. Dr. Veronika Somoza, University of Vienna
- Investigators
- Veronika Somoza, Prof. PhD, Principal investigator, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372188
- Sponsor's protocol ID
- GAS-14
- Status last verified
- Feb 2015
- First submitted
- 19 Dec 2014
- Last updated
- 26 Feb 2015
- Results posted
- No
Publications
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.
PubMed 22708700Rubach 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.
PubMed 24510512
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Caffeine With and Without a Bitter Masking Compound on Gastric pH, Taking Into Account the Effect on Satiety Hormones in Blood Plasma and on Food Intake
- ClinicalTrials.gov ID
- NCT02372188
- Acronym / sponsor ID
- GAS-14
- Conditions
- Change of Gastric pH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Water | Experimental | Other: water125 mL water are administered during or before gastric pH measurement |
| Caffeine | Experimental | Dietary Supplement: caffeine150 mg Caffeine and 125 mL water are administered during or before gastric pH measurement |
| Caffeine + homoeriodictyol sodium salt | Experimental | Dietary Supplement: caffein + homoeriodictyol sodium salt150 mg Caffeine + 30 mg homoeriodictyol sodium salt and 125 mL water are administered during or before gastric pH measurement |
| homoeriodictyol sodium salt | Experimental | Dietary Supplement: homoeriodictyol sodium salt30 mg homoeriodictyol sodium salt and 125 mL water are administered during the gastric pH measurement |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- good general state of health
- sensorically untrained
- BMI: 19 - 26 kg/m2
Key exclusion criteria (10 listed)
- gastro-intestinal disease or discomfort,
- metabolic diseases,
- H.pylori infection,
- smoking,
- increased sensibility towards caffeine,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| waterControl | Other | Water |
| caffeine | Dietary supplement | Caffeine |
| caffein + homoeriodictyol sodium salt | Dietary supplement | Caffeine + homoeriodictyol sodium salt |
| homoeriodictyol sodium salt | Dietary supplement | homoeriodictyol sodium salt |
Primary outcome
Change of the intragastral pH determined by the Heidelberg Detection system
Time frame: recorded over a time period from 1 - 60 min
3 secondary outcomes
Change of plasma levels of Serotonin, Ghrelin, PYY and GLP-1
Time frame: Plasma are taken at two time points before and after the gastric pH measurement during a time period between 15 - 60 min
Food intake
Time frame: after the gastric pH measurement on each testing day the subjects are served an ad libitum breakfast, and they have an open time frame how long they want to eat, max. 1 hour is anticipated
subjective feelings of hunger are recorded by means of visual analog scales (VAS)
Time frame: subjects are asked to fill the VAS out immediately before and after the gastric pH measurement, max. 2 min is anticipated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
- Background: PubMed 22708700Liszt 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.
- Background: PubMed 24510512Rubach 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronika Somoza, Prof. PhD principal investigator
University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water, caffeine and caffein + homoeriodictyol sodium salt in people with Change of Gastric pH, run by University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the intragastral pH determined by the Heidelberg Detection system (time frame: recorded over a time period from 1 - 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02372188, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2015.