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Food Addiction clinical trials

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NCT ID: NCT06387719 Recruiting - Obesity Clinical Trials

Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity

PREC-BED
Start date: July 21, 2023
Phase:
Study type: Observational [Patient Registry]

BACKGROUND: Binge eating disorder (BED) is the worldwide most-prevalent eating disorder. It is associated with psychiatric comorbidities and obesity, a high impact in life functioning, and high morbidity and mortality. First symptoms appear frequently in youths, who most commonly present incomplete (subthreshold) criteria for BED (precursor forms, PREC-BED). While some subjects will evolve from PREC-BED to BED, there is no gold standard to identify the clinical evolution. Information from prior studies suggest early alterations in reward and inhibitory brain circuits in PREC-BED may predict increased vulnerability or resilience to develop BED. Tools based on MRI brain connectivity analyses (MRI-BC), built on robust and interpretable connectivity whole-brain models, have proven successful in diagnostic classification and predicting certain clinical outcomes. OBJECTIVES: To study MRI-BC diagnostic markers of PREC-BED and to explore prognosis at 1 year of follow-up in a sample of adolescents with obesity (12-17 years old). METHODS: A) Transversal analytical design: 3-group (n=34 per group) comparison of neuroimaging (MRI-BC), neurocognitive and clinical markers in adolescents with obesity and i) BED, ii) PREC-BED, iii) no BED nor PREC-BED (Healthy group, HC). B) Longitudinal analytical design, pilot, exploratory: adolescents with PREC-BED will be evaluated in clinical and neurocognitive variables at 1 year. Baseline brain neuroimaging variables (alone and in combination with clinical and neurocognitive variables) will be analyzed as predictors of clinical prognosis, including conversion to BED.

NCT ID: NCT06327919 Completed - Clinical trials for Weight Regain After Bariatric Surgery and Food Addiction

Effects of Probiotic Supplementation With Weight Reducing Plan in Patients With Food Addiction and Weight Regain After Bariatric Surgery

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

To study the effects of probiotic supplementation with a weight loss program and cognitive behavioral therapy (CBT) on anthropometric measures, eating behavior, food addiction, and related hormone levels in patients with food addiction and weight regain after bariatric surgery, 50 patients who referred to obesity clinic with weight regain (regaining ≥10% nadir weight) after bariatric surgery (at least 18 months), and food addiction will be randomly allocated to receive a weight loss program and CBT plus either probiotic, or placebo for 12 weeks. At the first and the end of the intervention, anthropometric measurements, eating behavior, food addiction, leptin, serotonin, and oxytocin will be assessed and compared between groups.

NCT ID: NCT06249711 Recruiting - Obesity Clinical Trials

Ultrasonic Treatment of Food Addiction

USFADD
Start date: May 22, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate a new form of non-invasive deep brain therapy for food addiction. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled trial. The trial will evaluate brain target engagement using magnetic resonance imaging, Food Cravings Questionnaire-State, and changes in subject's weight over the course of the study.

NCT ID: NCT06044285 Recruiting - Food Addiction Clinical Trials

Ultra Crave: An Investigation of Ultra-Processed Food

Start date: August 5, 2023
Phase: N/A
Study type: Interventional

This study experimentally investigates whether a reduction in ultra-processed (UP) food intake (1) causes aversive withdrawal symptoms in humans, (2) increases the motivational salience of UP food cues and, if so, (3) whether these factors undermine the ability to adhere to a low-UP diet. The following aims and hypotheses are tested: Aim 1: To investigate whether aversive physical, cognitive, and affective withdrawal symptoms emerge in response to reduced UP food intake compared to a high-UP diet, and whether this predicts failure to adhere to a low-UP diet. H1a: Reducing UP food intake will result in aversive physical, cognitive, and affective withdrawal symptoms, as indicated by 1) ecological momentary assessment (EMA) reports of aversive withdrawal symptoms, and 2) heart rate reactivity and subjective distress to an in-lab stressor. H1b: Aversive symptoms of UP food withdrawal will predict greater UP food intake and higher blood glucose levels when trying to adhere to a low UP diet. Aim 2: To investigate whether increased motivational salience of UP food cues emerges in response to reduced UP food intake, and whether this predicts failure to maintain a low-UP diet. H2a: Reducing UP food intake will result in increased motivational salience of UP food cues, as indicated by 1) EMA reports of UP food craving, 2) heart rate reactivity and subjective craving in a simulated fast-food restaurant, 3) heightened reinforcement value for UP food relative to other reinforcers, and 4) greater reward-related neural response to UP food cues. H2b: Increased motivational salience of UP food cues will predict greater UP food intake and higher blood glucose levels when trying to adhere to a low UP diet.

NCT ID: NCT06030362 Recruiting - Obesity Clinical Trials

Probiotic Intervention Study

Start date: July 18, 2023
Phase: N/A
Study type: Interventional

The current standard of care for obesity is the optimal management of comorbid conditions such as diabetes and hyperlipidemia, and counseling on diet, weight loss, or increased physical activity programs. However, lifestyle, diet, and behavioral interventions may provide between 7-10% reduction in initial weight and even fewer with long-term weight loss. In severely obese patients (BMI>40 or BMI>35 with comorbidities), bariatric surgery is also a potential treatment, but there is a high barrier for patients to undergo surgery for weight loss. These barriers include an aversion to major abdominal surgery, long recovery time, potential risk of vitamin deficiency, and risk for abdominal pain. For these reasons, there is a paramount need for other treatments for obesity and for food addiction. The current standard of care for obesity and food addiction is difficult to implement and lacks sustained efficacy. Most struggle to complete treatment, lose minimal weight, lack sustained weight loss, and engage in the well-known "YoYo" diet phenomenon. While bariatric surgery is currently the only effective treatment for obesity, there are several barriers associated with it such as eligibility requirements, invasiveness, difficult recovery, and cost making it not readily available for everyone. Some approved medications that help with obesity, such as orlistat, lorcaserin, or naltrexone-bupropion, have not been widely adopted by providers or patients due to their limited responses and adverse side effects. Probiotic cocktails have shown to be safe with little to no side effects. Preclinical models of probiotics demonstrate the ability to curb obesity in animal models. Therefore, a probiotic that is able to show significant weight loss along with lifestyle modifications would be highly adopted and desirable.

NCT ID: NCT05772052 Recruiting - Obesity Clinical Trials

Abnormal Eating and Taste Perception in Subjects With Obesity

TASTEOB
Start date: November 2, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT05649189 Completed - Food Addiction Clinical Trials

Differences in Length of Telomere in Food Addicted vs Non Food Addicted Persons

Start date: October 17, 2021
Phase:
Study type: Observational

The purpose of this descriptive study is to examine telomere length between two groups of people, those with and those without food addiction and identify possible relationships that may play a role in food addiction, it's behaviors and consequences. Research subjects would be adults age 19-70. They would be recruited from the Rural Nebraska Panhandle population. All COVID precautions will be enforced. Human subjects safety plans will be in place for this study.Eligibility: YaleFAS-2 Food Addiction Scale will be used to screen for presence or absence of food addiction. AT a later time, Eligible persons will be given the research consent form to read through and determine if they want to become a participant. If so, they will be consented. The participants will then be assigned an identification number to maintain confidentiality. Intervention: Participants will be given a Oragene saliva DNA collection kit to use and return to investigators. Evaluation:The Oragene saliva DNA collection kit will then be sent in for telomere length testing. Telomere Results will be correlated with food addiction diagnoses and behaviors to identify potential relationships. Follow up: Publication of results

NCT ID: NCT05437809 Recruiting - Obesity Clinical Trials

Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods

Start date: February 20, 2023
Phase: N/A
Study type: Interventional

The changing food environment, with increasingly abundant ultra-processed food (UPF) options, may directly contribute to rising rates of obesity, though it is unknown which ingredients in UPF elevate their reinforcing nature in a way that may lead to overconsumption. The proposed study is the first to systematically examine differences in the rewarding characteristics of and physiological and metabolic responses to UPFs that are high in fat, refined carbohydrates (like sugar), or both. Understanding the biobehavioral underpinnings that enhance the reinforcing potential of ingredients in UPF (e.g., fat vs. refined carbohydrates) can inform novel intervention targets for the treatment of overeating and obesity.

NCT ID: NCT05277714 Recruiting - Obesity Clinical Trials

Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.

CaDOb
Start date: May 25, 2022
Phase: N/A
Study type: Interventional

The hypothesis is that the increase in dlPFC brain activity via near-infrared spectroscopy-based Neurofeedback (fNIRS-based NF) training based on near-infrared spectroscopy would allow an improvement of the eating behavior, thus promoting a long-term weight loss in obese subjects. Patients will be trained during a month with 8 NF sessions and results based on clinical data and different questionnaires results will be compared between inclusion and 3 months later

NCT ID: NCT05233046 Not yet recruiting - Mental Health Issue Clinical Trials

Impact of Mindfulness Program on Perceived Wellness, Eating Habits and Relationship to Food

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

Mindfulness, seemingly a simple concept, research shows that the impact of mindfulness on the overall wellness of an individual can be helpful (5). Research supports that mindfulness leads to reduced stress, enhanced performance, better focus, and improved approach (7). Areas of mindfulnessare mindful eating,movement and meditation. Application of mindfulness tools in these areas can be beneficial to health outcomes and to create a happier more efficient work environment (9). Mindful eating shows to improve diet quality and attitudes toward food and eating. Individuals better understand physical hunger/fullness cues, improve nutrient density, weight control,digestion,systolic blood pressure, and stress(2). Disordered eating behaviors have also shown to improve(3). Mindless eating, such as eating while being on the phone, driving, or watching television can have the opposite effect and can be linked to more emotional hunger cues. Combining mindful eating with diet therapy can lead to healthier food choices and a more positive feeling towards eating and body image, reducing stress and improving the overall wellness of an individual (4). Aspire's experience shows that aspects of teacher's wellness is worsening with ,media reporting more and more employees resigning from their positions every day (wccb,2021). Teachers have voiced their need for more support with their wellbeing. As a result, Aspire Nutrition is targeting school employees through a newly developed mindfulness program titled Nourish Carolina. This program will be focused on improving the overall wellness of participants Participants are enrolled in the study for 12 weeks. All participants will have weekly nutritional counseling and bi-weekly mental health counseling. Study group will have nutrition and mental health counseling with mindfulness activities and control group will receive nutrition and mental health sessions without mindfulness activities. There is a program curriculum so that mental health and nutrition mindfulness activities compliment eachother The mindfulness lessons for study group are divided into 6 nutrition and 6 mental health sessions,for 15 minutes during the session. Positive outcomes could include improved workplace performance as a result of enhancing school employees overall wellness and quality of life by reducing stress levels, improving diet quality, and improving mental health.