The PRO-SOma COla (PROSOCO) Study

Launched by UNIVERSITY OF COPENHAGEN · Nov 1, 2023

Keywords

ClinConnect Summary

The PRO-SOma COla (PROSOCO) Study is a research trial aimed at understanding how the body releases a hormone called somatostatin, which plays a role in various bodily functions. The researchers want to see if they can measure a substance in the blood, called pro-somatostatin 1-64, to help gauge somatostatin levels. To do this, they will change the acidity in the stomach using a special medication and then check how this affects the hormone’s release.

Healthy adults aged 18 and older may be eligible to participate, as long as they are not pregnant, do not have a history of significant gastrointestinal issues, and meet other specific health criteria. Participants will take capsules one day containing a medication to change stomach acidity and another day a placebo (a pill with no active ingredients). On the study days, after not eating overnight, they will drink a mixture of Coca-Cola Zero and lemon juice, and blood samples will be taken before and after this drink to measure hormone levels. This study is currently recruiting participants, and anyone considering joining should be prepared for a couple of visits and some blood tests.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Non-diabetic fasting plasma glucose (\< 7.0 mmol/L) at time of inclusion
• • Normal weight and weight stable
• • Written informed consent
• Exclusion Criteria:
• • 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