Abnormal Eating and Taste Perception in Subjects With Obesity

Obesity Clinical Trial

— TASTEOB  

Official title:

Food Addiction, Binge Eating Disorder and Taste Perception in Subjects With Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772052
• Other study ID #: 43C002
• Status: Recruiting
• Start date: November 2, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Luisa Gilardini, MF
• Phone: +0261911
• Email: l.gilardini[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Addiction
• Obesity

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sweet taste recognition threshold	The sweet taste recognition threshold is assessed in subjects without eating disorders, with FA,with BE and FA+ BE	baseline
Primary	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	prevalence of binge eating (BE)	percentage of subjects recruited with BE	baseline
Secondary	prevalence of Food Addiction (FA)	percentage of subjects recruited with FA	baseline
Secondary	prevalence of Food Addiction (FA) + Binge Eating (BE)	percentage of subjects recruited with FA+BE	baseline