Ghrelin Plus Strength Training in Frail Elderly Study

What Was Tested

This registered phase 2 trial tested Ghrelin.

Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss.

There are currently no approved therapies for frailty.

Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain.

It had two arms (groups): Ghrelin plus resistance training (active comparator) and Placebo plus resistance training (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

16 actual participants took part.

It was open to people of any sex aged from 70 years with no upper age limit.

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

Examples of who could join: Individuals with three, four or five frailty criteria using the Fried frailty criteria.

The full record lists 1 inclusion and 20 exclusion criteria; among the exclusions: hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months; new york heart association class iii or iv congestive heart failure; therapy for cancer in the past 12 months, except non-melanoma skin cancer.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

The Ghrelin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Ghrelin, so expectations could not easily colour the readings.

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

It started in 2013-07-01 with completion listed for 2016-08-31.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Change in the Short Physical Performance Battery (SPPB) (time frame: Baseline to 12 weeks). Treatment-associated Adverse Events (time frame: Twelve weeks).

It also tracked 6 secondary outcomes, for example Change in Weight, Change in Lean Body Mass, Change in Muscle Strength, Change in Food Intake, Change in Quality of Life and Change in Frailty Status.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Ghrelin in 16 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.