Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones

What Was Tested

In this not phased trial, researchers set out to test Ghrelin.

Ghrelin, an acylated peptide consisting of 28 amino acids, is the endogenous ligand of the growth hormone secretagogue receptor (GHS-R).

It is synthesized predominantly in the stomach but has been also identified in a variety of other organs.

Alike, a wide range of central and peripheral endocrine and non-endocrine actions has been described, e. g. being a releasing factor of growth hormone, prolactin and ACTH, a modulator of cell proliferation and apoptosis, a regulator of sleep-wake regulation, and a orexigenic hormone.

The registry classes the interventions as drug.

Who Took Part

80 planned participants were the target.

It was open to people of any sex aged from 20 years up to 70 years.

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

Examples of who could join: Healthy females and males. Male and female patients with major depression.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: life time or family history of psychiatric or neurological disorders; sleep disturbances; shift work.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

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

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

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

Those kept unaware of assignments: participant.

It started in 2004-03 with completion listed for 2007-10.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: sleep, conventionally and quantitatively analyzed (time frame: study duration).

It also tracked 1 secondary outcome, for example hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Ghrelin in 80 people.

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

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