The PRO-SOma COla (PROSOCO) Study

NCT06121245 | Unknown DMC

• 1 other identifier: PROSOCO
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Healthy

Keywords

somatostatin; secretion; peptide; pro-somatostatin 1-64

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of pro-somatostatin 1-64

  Peptide released from D-cells in the gut in equimolar concentrations alongside somatostatin

  baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min

Secondary Outcomes (5)

• Plasma concentration of gastrin

  baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min

• Plasma concentration of cholecystokinin

  baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min

• Plasma concentration of secretin

  baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min

• Plasma concentration of pancreatic polypeptide

  baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min

• Plasma concentration of glucose

  baseline samples, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120 min

Study Arms (2)

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

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

Other: Placebo

Interventions

Proton Pump inhibitor OTHER

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)

Esomeprazol

Placebo OTHER

Placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Normal weight and weight stable
• Written informed consent

You may not qualify if:

• 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.)
• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Hvidovre University Hospital: collaborator

Study Sites (2)

University of Copenhagen

Copenhagen, Capital, 2200, Denmark

RECRUITING

Hvidovre University Hospital

Hvidovre, Capital, 2650, Denmark

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Proton Pump Inhibitors

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jens J Holst, MD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Veedfald, MD

CONTACT

+45 41102595; veedfald@sund.ku.dk

Clara T Winding, BM

CONTACT

clara_winding@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Pharmacy prepared placebo.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Randomized, double-blind, placebo-controlled, crossover study

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 7, 2023
• Study Start: September 13, 2023
• Primary Completion: November 1, 2023
• Study Completion: February 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

DK (2)