The FULFILL study
Research type
Research Study
Full title
Placebo-Controlled, Double-Blinded, Single-Dose Strength, Randomized Mechanistic study to Assess the physiological effect of Lingual Administration of gut hormones on Food Intake in Subjects with Obesity.
IRAS ID
327046
Contact name
Alex Miras
Contact email
Sponsor organisation
Ulster Univeristy
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Summary
Background: Gut hormones, such as PYY and GLP-1, released postprandially mainly by the gut can promote satiation and reduce hunger. While intravenous, oral and injected administration of these hormones has been found to be effective in reducing food intake they have also been found to be poorly tolerated causing nausea and other gastrointestinal issues (vomiting, diarrhoea, etc.). Animal work has shown that lingual hormone administration signals directly to the satiety centres of the brain via the receptors on the tongue (e.g. NPY2R and GLP-1R), thus avoiding stimulation of the nausea centres.
Study Aim: To investigate the effect of lingual gut hormone administration on food intake.
Design: The study is a physiological study with a placebo-controlled, single-dose strength, double-blinded, randomised crossover design, which will assess the effect of lingual gut hormone administration compared to placebo on food intake in subjects with obesity.
Outcomes measures: Energy intake (primary), circulating gut hormone concentrations and adverse reactions.
Application: If the lingual administration of gut hormones is shown to be successful in reducing appetite without the adverse reactions associated with systemically administered gut hormones, this topical lingula (T-L) delivery mode may present an opportunity for the development of an effective treatment for obesity.REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/0565
Date of REC Opinion
25 Aug 2023
REC opinion
Further Information Favourable Opinion