Food Reward Circuit Change by Orthodontics (DTI)

Assessment of Food Reward Circuit Change in Individuals Receiving Orthodontic Treatment With Diffusion Tensor Imaging

It has been described in obese individuals in which decreased basal metabolism as well as dopaminergic changes in the prefrontal cortex and striatum parallels the increased activation of reward brain regions in response to delicious food cues. Our aim is to explore different neurobehavioral dimensions of food choices and motivational processes in the light of this information, and to reveal whether these behaviors can be changed by operant conditioning with neuroimaging methods for phenotypes at risk.

Study Overview

• Status: Active, not recruiting
• Conditions: Eating Disorders; Eating Behavior; Orthodontic Appliance Complication; Eating Habit
• Intervention / Treatment: Diagnostic test: T 0 Diffusion Tensor MR; Diagnostic test: T 1 Diffusion Tensor MR; Diagnostic test: T 2 Diffusion Tensor MR

Detailed Description

The incidence of eating disorders in society is increasing day by day and is becoming an increasingly serious problem. Overweight people are suggested to exhibit eating behavior to cope with anxiety, depressed mood, anger and other negative emotions. Studies in humans and animals have shown that obesity is associated with changes in dopaminergic neurotransmission. Changes in brain locations associated with satiety and hunger centers (hypothalamus, hippocampal gyrus, amygdala, insula, cerebellum and midbrain) of obese patients have been shown. It has been reported that cognitive control strategies that can lead to more effective impulse control behaviors should be applied for obesity treatment, which is considered as an addiction in which food is perceived as a reward nowadays.

During the first week of fixed orthodontic treatment, all the patients have pain and various discomforts with food, and after each appointment, the pain occurs while chewing. Patients declare having prolonged eating times due to difficulty in chewing, food impaction under the brackets and complains about not being able to consume sugar-containing foods due to maintain oral hygen. It is known that individuals who have eating disorders have a disturbance in their food rewarding properties and eating behavior. They eat in response to emotions rather than to meet energy needs. Pharmacological and bariatric surgical interventions are more successful than dietary lifestyle interventions because these interventions reduced not only the hunger but also the reward value of the homeostatic and hedonic brain regions of the foods. However, there is no study of whether enjoying from the food, perceiving food as a reward or individuals eating habits can be changed. The hypothesis of this study is that as a result of orthodontic treatment in which individuals experience negative emotions during each meal for two years there will be a change in the way of individuals' interpretation of food.

In order to investigate this hypothesis, eating attitudes and eating habit questionnaires will be applied to healthy volunteers with a body mass index of 25 and above chosen from patients who applied to our clinic for fixed orthodontic treatment. Thus, individuals with emotional eating, externally induced eating, restrained eating disorders and eating habits of these individuals will be identified. Magnetic resonance images will be taken from 20 individuals with eating disorders before fixed orthodontic treatment, 12 months of orthodontic treatment and 6 months after orthodontic treatment finished. By means of magnetic resonance imaging (MRI) and diffusion tensor imaging (DTG), the microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined. The presence of changes by the orthodontic treatment in nutritional perceptions will be measured.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34844
      • Banu Kilic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients thought to have emotional eating, restrained eating and external eating.
2. patients between the ages of 18-60
3. Patients with minor to moderate crowding in the mandibular and maxillary arches not exceeding 7 mm
4. Orthodontic patients who need to be treated with fixed treatment without extraction.
5. Class 1 healthy patients according to the American Society of Anesthesiologists (ASA) criteria 20 individuals selected from amongst will constitute our main sample group.

Exclusion Criteria:

1. Maxillary expansion apparatus, transpalatal arch, Herbst, Forsus etc. before fixed treatment. Patients who require fixed non-treatment devices such as fixed devices will not be included in the study.
2. Patients who require constant use of devices containing materials that may contain steel other than tubes and brackets as orthodontic materials will not be included.
3. Although it could not be detected at the beginning of the treatment if any of the treatment methods (extraction, etc.) other than the standardized protocol are required in the future, the patient will be excluded from the study.
4. Before the patients start orthodontic treatment, a consultation will be requested from the Department of Mental Health and Diseases and the patients who are not found suitable will be excluded from the study by the initiative of the psychiatrist who examines the patient without asking a reason for the doctor-patient confidentiality.
5. Before the patients start orthodontic treatment, a consultation will be requested from the dietician and the patients who are not found suitable will be excluded from the study by the initiative of the dietician who examines the patient without asking a reason for the doctor-patient confidentiality.
6. Before the patients start orthodontic treatment, a consultation will be requested from the internal medicine doctor if there is any doubt that there may be an organic basis for patients to have a high BMI. The patients who are not found suitable will be excluded from the study by the initiative of the internal medicine doctor who examines the patient without asking a reason for the doctor-patient confidentiality.
7. Patients using medical treatment due to a known disease before orthodontic treatment will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Orthodontic patients; Magnetic resonance images will be taken from 20 individuals with eating disorders before fixed orthodontic treatment, 12 months of orthodontic treatment and 6 months after orthodontic treatment finished

Diagnostic test: T 0 Diffusion Tensor MR; Magnetic resonance images has been taken from 20 individuals with eating disorders before fixed orthodontic treatment; Diagnostic test: T 1 Diffusion Tensor MR; Magnetic resonance images will be taken from 20 individuals with eating disorders after 12 months of orthodontic treatment.; Diagnostic test: T 2 Diffusion Tensor MR; Magnetic resonance images will be taken from 20 individuals with eating disorders 6 months after orthodontic treatment finished

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T0 -T1 DTMR fractional anisotropy change	The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined. Fractional anisotropy, apparent diffusion coefficient, mean diffusivity and radial diffusivity parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)	12 months
T1-T2 DTMR fractional anisotropy change	The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined after orthodontic treatment. Fractional anisotropy parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)	6 months after the end of fixed orthodontic treatment
T0 -T1 DTMR apparent diffusion coefficient change	The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined. Apparent diffusion coefficient parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)	12 months
T1-T2 DTMR Apparent diffusion coefficient change	The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined after orthodontic treatment. Apparent diffusion coefficient parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)	6 months
T0 -T1 DTMR mean diffusivity change	The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined. Mean diffusivity parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)	12 months
T1-T2 DTMR mean diffusivity change	The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined after orthodontic treatment. Mean diffusivity change parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)	6 months
T0 -T1 DTMR Radial diffusivity change	The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined. Radial diffusivity parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)	12 months
T1-T2 DTMR radial diffusivity change	The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined after orthodontic treatment. Radial diffusivity parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T0-T1 Dutch Eating Behaviour Questionnaire Score Change	33 items, which measures emotional (13 items), external, and restrained eating (both 10 items) rated on a five-point scale from 1 (never) to 5 (very often) will be evaluated. The presence of changes at eating behaviour by the orthodontic treatment in nutritional perceptions will be measured. A decrease in DEBQ scores will be perceived as a positive improvement.	12 months
T1-T2 Dutch Eating Behaviour Questionnaire Score Change	33 items, which measures emotional (13 items), external, and restrained eating (both 10 items) rated on a five-point scale from 1 (never) to 5 (very often) will be evaluated. If there is a presence of changes at eating behavior by the orthodontic treatment we will be able to measure if they are stable or not. A decrease in DEBQ scores or a stabilization of the dropped score will be perceived as a positive development.	6 months after the end of fixed orthodontic treatment
T0-T1 Eating Attitude Test Score Change	It includes 40 items in which the frequencies of attitudes and beliefs are rated using 6-point scale. A score of 30 and above is commonly used as a cut-off point to identify individuals with anorexia or bulimia. The presence of changes at eating attitude by the orthodontic treatment in nutritional perceptions will be measured. A decrease in Eating Attitude Test scores will be perceived as a positive development.	12 months
T1-T2 Eating Attitude Test Score Change	It includes 40 items in which the frequencies of attitudes and beliefs are rated using 6-point scale. A score of 30 and above is commonly used as a cut-off point to identify individuals with anorexia or bulimia. If there is a presence of changes at eating attitude by the orthodontic treatment we will be able to measure if they are stable or not. Eating Attitude Test scors falling or remaining stable will be perceived as a positive development.	6 Months

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Collaborators: Muğla Sıtkı Koçman University; The Scientific and Technological Research Council of Turkey; Balikli greek hospital foundation
• Investigators: Study Director: Banu Kılıç, Bezmialem Vakif University

Publications and helpful links

General Publications

• Sergl HG, Klages U, Zentner A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. Am J Orthod Dentofacial Orthop. 1998 Dec;114(6):684-91. doi: 10.1016/s0889-5406(98)70201-x.
• Garcia-Garcia I, Horstmann A, Jurado MA, Garolera M, Chaudhry SJ, Margulies DS, Villringer A, Neumann J. Reward processing in obesity, substance addiction and non-substance addiction. Obes Rev. 2014 Nov;15(11):853-69. doi: 10.1111/obr.12221. Epub 2014 Sep 29.
• Bozan N, Bas M, Asci FH. Psychometric properties of Turkish version of Dutch Eating Behaviour Questionnaire (DEBQ). A preliminary results. Appetite. 2011 Jun;56(3):564-6. doi: 10.1016/j.appet.2011.01.025. Epub 2011 Jan 26.
• Kroemer NB, Small DM. Fuel not fun: Reinterpreting attenuated brain responses to reward in obesity. Physiol Behav. 2016 Aug 1;162:37-45. doi: 10.1016/j.physbeh.2016.04.020. Epub 2016 Apr 13.
• Alkan A, Sahin I, Keskin L, Cikim AS, Karakas HM, Sigirci A, Erdem G. Diffusion-weighted imaging features of brain in obesity. Magn Reson Imaging. 2008 May;26(4):446-50. doi: 10.1016/j.mri.2007.10.004. Epub 2007 Dec 11.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: bkilic002; 119S125 (Other Grant/Funding Number: THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TURKEY)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No