NCT05772052

Brief Summary

The identification of safe and effective strategies for weight loss and long-term maintenance is critical to reduce the alarming prevalence of obesity worldwide and mitigate obesity-associated health risks. Specifically, Binge Eating (BE) and Food Addiction (FA) behaviors are well known causes of failed weight loss and weight regain. The definitions of their clinical phenotypes are currently evolving. Recent evidence suggests that food choices, behavior and reward may be driven also by taste perception. The hypothesis of this study is that subjects with dysfunctional eating behavior have different taste thresholds compared to obese subjects without eating disorders, and that this characteristic influences food choice and eating behavior. Identifying a difference in the taste thresholds between obese with and without eating disorder will allow us to understand why certain individuals over-consume or binge on densely caloric foods and to give them a tailored dietary treatment so as to maintain weight loss for a long time. The Binge eating and Food Addiction is assessed using Binge Eating Scale and Yale Food Addiction Scale 2.0. Subjects with obesity recruited are divided in 4 groups: without eating disorder, with food addiction (FA), with binge eating (BE) and with FA + BE. In these groups sweet and salty taste will be measured with the 3-Alternative-Forced-Choice method.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Nov 2020Dec 2026

Study Start

First participant enrolled

November 2, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

6.2 years

First QC Date

March 6, 2023

Last Update Submit

September 30, 2025

Conditions

Keywords

Taste; Obesity; Food addiction; Binge eating; sweet; salty

Outcome Measures

Primary Outcomes (2)

  • sweet taste recognition threshold

    The sweet taste recognition threshold is assessed in subjects without eating disorders, with FA,with BE and FA+ BE

    baseline

  • salt taste recognition threshold

    The salt taste recognition threshold is assessed in subjects without eating disorders, with FA,with BE and FA+ BE

    baseline

Secondary Outcomes (3)

  • prevalence of binge eating (BE)

    baseline

  • prevalence of Food Addiction (FA)

    baseline

  • prevalence of Food Addiction (FA) + Binge Eating (BE)

    baseline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Subjects with obesity referred to Istituto Auxologico Italiano for weight loss program

You may qualify if:

  • BMI\>30 kg/m2 and \<45 kg/m2

You may not qualify if:

  • uncooperative patients
  • heavy smokers
  • pregnancy or recent (in the last 6 months) childbirth
  • thyroid disorders
  • presence of endocrine abnormalities associated with obesity
  • current or recent oral, nasal or sinus infections
  • major psychiatric disorder even in pharmacological compensation
  • patients who had undergone bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20145, Italy

RECRUITING

Related Publications (4)

  • Aloi M, Rania M, Rodriguez Munoz RC, Jimenez Murcia S, Fernandez-Aranda F, De Fazio P, Segura-Garcia C. Validation of the Italian version of the Yale Food Addiction Scale 2.0 (I-YFAS 2.0) in a sample of undergraduate students. Eat Weight Disord. 2017 Sep;22(3):527-533. doi: 10.1007/s40519-017-0421-x. Epub 2017 Aug 5.

    PMID: 28780748BACKGROUND
  • Arlt JM, Smutzer GS, Chen EY. Taste assessment in normal weight and overweight individuals with co-occurring Binge Eating Disorder. Appetite. 2017 Jun 1;113:239-245. doi: 10.1016/j.appet.2017.02.034. Epub 2017 Feb 24.

    PMID: 28242311BACKGROUND
  • Bertoli S, Leone A, Ponissi V, Bedogni G, Beggio V, Strepparava MG, Battezzati A. Prevalence of and risk factors for binge eating behaviour in 6930 adults starting a weight loss or maintenance programme. Public Health Nutr. 2016 Jan;19(1):71-7. doi: 10.1017/S1368980015001068. Epub 2015 May 11.

    PMID: 25958773BACKGROUND
  • Proserpio C, Laureati M, Bertoli S, Battezzati A, Pagliarini E. Determinants of Obesity in Italian Adults: The Role of Taste Sensitivity, Food Liking, and Food Neophobia. Chem Senses. 2016 Feb;41(2):169-76. doi: 10.1093/chemse/bjv072. Epub 2015 Dec 15.

    PMID: 26671250BACKGROUND

MeSH Terms

Conditions

ObesityFood AddictionBulimia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorFeeding and Eating DisordersMental DisordersHyperphagiaSigns and Symptoms, Digestive

Study Officials

  • Simona Bertoli, MD

    Istituto Auxologico Italiano

    STUDY CHAIR

Central Study Contacts

Luisa Gilardini, MF

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 16, 2023

Study Start

November 2, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 3, 2025

Record last verified: 2025-09

Locations