Ghrelin in Cystic Fibrosis

What Was Tested

This registered not phased trial tested Ghrelin.

Background to ghrelin Ghrelin is a naturally occurring hormone found in the blood which stimulates appetite.

In healthy individuals, levels of ghrelin are high before a meal and falls afterwards.

It had 1 arm (groups): saline injections (placebo comparator).

The registry classes the interventions as biological.

More on the Plan

The purpose of this study is to investigate the role of a naturally occuring hormone called ghrelin on appetite, energy expenditure and immune function in patients with cystic fibrosis.

Theoretical framework: Despite advances in the molecular understanding of the disease, life-expectancy in Cystic Fibrosis (CF) remains severely limited.

Malnutrition is highly prevalent in the CF population and results from both poor food intake and excessive energy expenditure.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: BMI \</=19 kg/m2.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: needle phobia; pulmonary infection requiring intravenous antibiotics in the past 2 weeks-.

How the Study Was Run

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

Because people in this Ghrelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Ghrelin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2010-04 with completion listed for 2011-02.

It ran at 1 site in United Kingdom.

Its stated primary purpose is health services research.

What Was Measured

Researchers chose this as the main measure: Appetite (time frame: 4 weeks).

It also tracked 1 secondary outcome, for example weight.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Ghrelin in 20 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Ghrelin compound page, all human trials.