Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders

What Was Tested

The trial (not phased) is built around Ghrelin and Alpha-MSH.

This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation.

It had two arms (groups): Eating disorders patients (experimental) and healthy volunteers (other).

Volunteers with negative SCOFF test (No active or history of eating disorders).

The registry classes the interventions as other.

More on the Plan

Eating disorders are a public health issue.

It has been recently reported the importance of immune system modifications in eating disorders physiopathology, involving autoantibodies directed against neuropeptides regulating food intake.

The autoAc directed against the latter also react with α-MSH because of these similarity of structures, thus leading to a potential digestive origin of these autoAc.

To consolidate this new etiopathogenic assumption, a large clinical study is necessary with analysis of patients autoAc profiles. a monocentric study with inclusion of 240 patients over 2 years and 80 healthy volunteers is proposed.

Who Took Part

Enrollment: 211 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: 18 Years and older. Anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V. Social security Affiliation. Patient who signed the MEC approved informed consent. 18 Years to 60 Years.

The full record lists 11 inclusion and 6 exclusion criteria; among the exclusions: no anorexia nervosa, hyperphagia or bulimia according to the classification dsm-v; adults under legal protection or under safeguard of justice or administrative decision; active or history of eating disorder.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

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

Nothing was hidden in this open-label Ghrelin study: the participants and staff both knew the treatment.

It started in 2018-05-24 with completion listed for 2025-08-13.

It ran at 1 site in France.

Its stated primary purpose is health services research.

What Was Measured

Researchers chose this as the main measure: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) involved in food intake regulation among patients with eating disorders (time frame: 1 week).

It also tracked 3 secondary outcomes, for example statute in autoantibody and behavioral characteristics of the eating disorder and Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB among patients presenting with eating disorders.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Ghrelin and Alpha-MSH in 211 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 and the Alpha-MSH compound page, all human trials.