Clinical trial NCT05772052: Abnormal Eating and Taste Perception in Subjects With Obesity
Official title: Food Addiction, Binge Eating Disorder and Taste Perception in Subjects With Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Taste; Obesity; Food addiction; Binge eating; sweet; salty
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with obesity referred to Istituto Auxologico Italiano for weight loss program

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.


Eligibility criteria: Inclusion Criteria:

* BMI\>30 kg/m2 and \<45 kg/m2

Exclusion Criteria:

* 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

Primary outcomes:
measure: sweet taste recognition threshold
timeFrame: baseline
measure: salt taste recognition threshold
timeFrame: baseline
Secondary outcomes:
measure: prevalence of binge eating (BE)
timeFrame: baseline
measure: prevalence of Food Addiction (FA)
timeFrame: baseline
measure: prevalence of Food Addiction (FA) + Binge Eating (BE)
timeFrame: baseline
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
affiliation: Istituto Auxologico Italiano
name: Simona Bertoli, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.