Ghrelin in Healthy and Frail Older Women

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Ghrelin.

Ghrelin is a naturally occurring hormone that is produced mostly by the stomach and causes secretion of another hormone called growth hormone.

It had four arms (groups): Healthy 70+ Women Placebo Infusion (placebo comparator), Frail 70+ Women Placebo Infusion (placebo comparator), Healthy 70+ Women Ghrelin Infusion (active comparator) and Frail 70+ Women Ghrelin Infusion (active comparator).

Healthy and Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion.

Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion.

The registry classes the interventions as drug and other.

More on the Plan

Women with conditions that can cause weight loss or taking an appetite stimulant or corticosteroids were excluded.

A meal of standardized composition was provided after each infusion and intake quantified.

Samples were collected every 30 minutes for growth hormone (GH), and total and active ghrelin.

Additional samples were collected every 60 minutes for glucose, insulin, free fatty acids, leptin, adiponectin, resistin, glucagon-like peptide-1 receptor agonists (GLP-1), and cortisol.

Who Took Part

10 actual participants took part.

It was open to women only aged from 70 years with no upper age limit.

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

Examples of who could join: Women aged 70 or greater. Able to give informed consent. Two of the following four criteria (from Fried L et al, 2001): low grip strength, slow walking speed, subjective exhaustion, low levels of physical activity. Women aged 70 or greater. Able to give informed consent.

The full record lists 7 inclusion and 23 exclusion criteria; among the exclusions: prior diagnosis of parkinson's disease; history of cerebrovascular accident with residual hemiparesis; hospitalization for treatment of vascular disease (including, coronary heart disease, cerebrovascular disease, peripheral vascular disease) in the past 6 months.

How the Study Was Run

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

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.

Blinding on both sides kept the participants and researchers unaware of who received Ghrelin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2007-03 with completion listed for 2008-12.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Kilocalories Consumed (time frame: After infusion). Max Change Growth Hormone (time frame: 180 minutes). Max Change Total Ghrelin (time frame: 180 minutes).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Ghrelin in 10 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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