HealthyPROSOCONCT06121245
The PRO-SOma COla (PROSOCO) Study
A study testing Proton Pump inhibitor in people with Healthy, run by University of Copenhagen at 2 sites in Denmark.
Trial summary
The goal of this randomized, double-blind, placebo-controlled, crossover study is to determine whether it is possible to gauge the pattern of somatostatin secretion by measuring plasma concentrations of pro-somatostatin 1-64 (a stable peptide that is released in equimolar amounts alongside somatostatin) as a surrogate… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Proton Pump inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 2 sitesDenmark
- Study dates
- 13 Sep 2023to Feb 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Non-diabetic fasting plasma glucose (< 7.0 mmol/L) at time of inclusion
- Normal weight and weight stable
- Written informed consent
Who cannot join
- Pregnancy or breastfeeding
- Haemoglobin < 7.9 mmol/L
- Prior gastrointestinal operations excluding uncomplicated appendectomy
- Significant gastrointestinal symptoms (e.g. dyspepsia, postprandial pain)
- Intolerance to aspartame
- Use of medication that may influence blood pressure, gastrointestinal motor function, body weight or appetite (e.g. antihypertensive drugs, anticholinergic drugs (e.g. atropine, hyoscine), prokinetic drugs (metoclopramide, domperidone, erythromycin), orlistat, green tea extracts, astragalus, St. John's Wort etc.)
Show all 10Show fewer
- Evidence of drug abuse, consumption of tobacco in any form or daily consumption of more than 20g alcohol
- History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery including cholecystectomy (but not uncomplicated appendectomy) Participation in any other research studies within the previous 3 months
- Inability to give informed consent
- Non-Probability Sample: Any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer
Trial locations and contacts
2 sites in 1 country.
Clara T Winding, BM contact
Denmark2 sites, 1 recruiting
- Recruiting
University of Copenhagen
Copenhagen, Capital, 2200
Clara T Winning, BM, clara_winding@sund.ku.dk
Simon Veedfald, MD, +45 41102595, veedfald@sund.ku.dk
- Active, not recruiting
Hvidovre University Hospital
Hvidovre, Capital, 2650
About this study
Official title: Evaluating the Release of the Entero-pancreatic Hormone Somatostatin by Measuring Stable Co-secreted Prosomatostatin Moieties in the Plasma of Healthy Individuals - the PRO-SOma COla (PROSOCO) Study
The goal of this randomized, double-blind, placebo-controlled, crossover study is to determine whether it is possible to gauge the pattern of somatostatin secretion by measuring plasma concentrations of pro-somatostatin 1-64 (a stable peptide that is released in equimolar amounts alongside somatostatin) as a surrogate marker. During the study the release of somatostatin will be manipulated by changing the luminal pH of the stomach.
Healthy participants will be studied in a randomized on two occasions. The day before both two study visits participants will ingest a capsule in the morning and a capsule in the evening. On one day the capsule will contain a proton pump inhibitor (Esomeprazol) to elevate the luminal pH of the stomach and on the other day the capsule will be a placebo. On the study days participants will ingest, in the mornng after an overnight fast, a coca cola zero + lemon juice to lower the luminal pH which willelicit the release of somatostatin. Blood samples will be collected before and after the ingestion of coca cola.
Read the detailed description
Somatostatin is a polypeptide that plays a key regulatory role in the gastrointestinal tract and pancreas. It has been attempted to determine in peripheral plasma samples the pattern of somatostatin release. However, due to the brief half-life of somatostatin this it turns out is difficult. Therefore, the investigators have developed an antibodies and a radioimmunoassay that measures concentrations of a stable peptide termed prosomatostatin 1-64. This peptide is released in equimolar amounts alongside somatostatin from the somatostatin-producing cells in the gut.
The current study aims to demonstrate that prosomatostatin 1-64 can be picked up in peripheral plasma from human study participants. The release of somatostatin is increased when the pH of the stomach is low. The release of somatostatin will be elicited by asking participants coca cola zero with lemon juice. Participants will be studied on two occasions (on one day participants will be pretreated with a proton pump inhibitor, on the other day with a placebo). The two visits will be carried out as a placebo-controlled crossover study following a randomised schedule.
If successful, pro-somatostatin 1-64 can be as a surrogate marker of somatostatin secretion. This will allow investigations of somatostatin secretion dynamics in humans.
- Conditions
- Healthy
- Being tested
- Proton Pump inhibitor, Placebo
- Keywords
- somatostatin, secretion, peptide, pro-somatostatin 1-64
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Pump inhibitorOther
A proton pump inhibitor will be used as a tool to study the effect of pH changes in the stomach lumen on the release of somatostatin (evaluated by measurements of somatostatin and pro-somatostatin 1-64)
PlaceboOther
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazol | Experimental | On the day before the study visits participants will ingest a capsule in the morning on a capsule in the evening containing Esomperazol Receives: Other: Proton Pump inhibitor |
| Placebo | Placebo comparator | On the day before the study visits participants will ingest a capsule in the morning on a capsule in the evening containing a placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of pro-somatostatin 1-64
Peptide released from D-cells in the gut in equimolar concentrations alongside somatostatin
Measured: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Secondary outcomes (5)
Plasma concentration of gastrin
peptide hormone released from G cells in the antrum of the stomach
Measured: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Plasma concentration of cholecystokinin
peptide hormone released from I cells in the proximal small intestine
Measured: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Plasma concentration of secretin
Peptide hormone released from S cells in the small intestine
Measured: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Plasma concentration of pancreatic polypeptide
Peptide hormone released from the endocrine pancreas
Measured: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Plasma concentration of glucose
Measured: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start13 Sep 2023
- Primary completionNov 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Model description
- Randomized, double-blind, placebo-controlled, crossover study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Simon Veedfald, University of Copenhagen
- Investigators
- Jens J Holst, MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121245
- Sponsor's protocol ID
- PROSOCO
- Acronym
- PROSOCO
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Release of the Entero-pancreatic Hormone Somatostatin by Measuring Stable Co-secreted Prosomatostatin Moieties in the Plasma of Healthy Individuals - the PRO-SOma COla (PROSOCO) Study
- ClinicalTrials.gov ID
- NCT06121245
- Acronym / sponsor ID
- PROSOCO / PROSOCO
- Conditions
- Healthy
- Keywords
- somatostatin, secretion, peptide, pro-somatostatin 1-64
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 7 Nov 2023 (actual)
- 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 goal of this randomized, double-blind, placebo-controlled, crossover study is to determine whether it is possible to gauge the pattern of somatostatin secretion by measuring plasma concentrations of pro-somatostatin 1-64 (a stable peptide that is released in equimolar amounts alongside somatostatin) as a surrogate marker. During the study the release of somatostatin will be manipulated by changing the luminal pH of the stomach.
Healthy participants will be studied in a randomized on two occasions. The day before both two study visits participants will ingest a capsule in the morning and a capsule in the evening. On one day the capsule will contain a proton pump inhibitor (Esomeprazol) to elevate the luminal pH of the stomach and on the other day the capsule will be a placebo. On the study days participants will ingest, in the mornng after an overnight fast, a coca cola zero + lemon juice to lower the luminal pH which willelicit the release of somatostatin. Blood samples will be collected before and after the ingestion of coca cola.
Detailed description
Somatostatin is a polypeptide that plays a key regulatory role in the gastrointestinal tract and pancreas. It has been attempted to determine in peripheral plasma samples the pattern of somatostatin release. However, due to the brief half-life of somatostatin this it turns out is difficult. Therefore, the investigators have developed an antibodies and a radioimmunoassay that measures concentrations of a stable peptide termed prosomatostatin 1-64. This peptide is released in equimolar amounts alongside somatostatin from the somatostatin-producing cells in the gut.
The current study aims to demonstrate that prosomatostatin 1-64 can be picked up in peripheral plasma from human study participants. The release of somatostatin is increased when the pH of the stomach is low. The release of somatostatin will be elicited by asking participants coca cola zero with lemon juice. Participants will be studied on two occasions (on one day participants will be pretreated with a proton pump inhibitor, on the other day with a placebo). The two visits will be carried out as a placebo-controlled crossover study following a randomised schedule.
If successful, pro-somatostatin 1-64 can be as a surrogate marker of somatostatin secretion. This will allow investigations of somatostatin secretion dynamics in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, crossover study
| Arm | Type | Receives |
|---|---|---|
| Esomeprazol | Experimental | Other: Proton Pump inhibitorOn the day before the study visits participants will ingest a capsule in the morning on a capsule in the evening containing Esomperazol |
| Placebo | Placebo comparator | Other: PlaceboOn the day before the study visits participants will ingest a capsule in the morning on a capsule in the evening containing a placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Non-diabetic fasting plasma glucose (< 7.0 mmol/L) at time of inclusion
- Normal weight and weight stable
- Written informed consent
Key exclusion criteria (10 listed)
- Pregnancy or breastfeeding
- Haemoglobin < 7.9 mmol/L
- Prior gastrointestinal operations excluding uncomplicated appendectomy
- Significant gastrointestinal symptoms (e.g. dyspepsia, postprandial pain)
- Intolerance to aspartame
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 |
|---|---|---|
| Proton Pump inhibitorA proton pump inhibitor will be used as a tool to study the effect of pH changes in the stomach lumen on the release of somatostatin (evaluated by measurements of somatostatin and pro-somatostatin 1-64) | Other | Esomeprazol |
| PlaceboPlacebo capsule | Other | Placebo |
Primary outcome
Plasma concentration of pro-somatostatin 1-64
Time frame: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Peptide released from D-cells in the gut in equimolar concentrations alongside somatostatin
5 secondary outcomes
Plasma concentration of gastrin
Time frame: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Plasma concentration of cholecystokinin
Time frame: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Plasma concentration of secretin
Time frame: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Plasma concentration of pancreatic polypeptide
Time frame: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Plasma concentration of glucose
Time frame: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Clara T Winding, BM contact
Jens J Holst, MD principal investigator
University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Pump inhibitor in people with Healthy, run by University of Copenhagen at 2 sites in Denmark.
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 4 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. 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?
Contact Simon Veedfald, MD (+45 41102595, veedfald@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of pro-somatostatin 1-64 (time frame: baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.