Effect of Pancreatic Polypeptide on Gastric Motor Function and Food Intake in Humans

What Was Tested

In this phase 4 trial, researchers set out to test Pancreatic Polypeptide.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Twelve healthy volunteers participated in this single blind, placebo-controlled, crossover trial.

An infusion catheter and a manometry probe were positioned in the stomach.

GE was evaluated using the 13C breath test during the 6 hours following the ND infusion.

Satiation and hunger were scored on a visual analog scale every 5 minutes.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Subject is between 18 and 65 years of age. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: subject is under age of legal consent, pregnant or breastfeeding; history or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity; history or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit).

How the Study Was Run

The set-up was randomized, crossover and single-blind.

Random assignment meant chance, not the researchers, decided who got Pancreatic Polypeptide and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Pancreatic Polypeptide and the comparison in turn, acting as their own control.

Only one side, usually the participants, was kept unaware of whether Pancreatic Polypeptide was given.

Those kept unaware of assignments: participant.

It started in 2010-08-31 with completion listed for 2011-03-08.

It ran at 1 site in Belgium.

Its stated primary purpose is prevention.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Pancreatic Polypeptide in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Pancreatic Polypeptide compound page, all human trials.