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Hyperphagia clinical trials

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NCT ID: NCT06420297 Enrolling by invitation - Clinical trials for Hyperphagia in Prader-Willi Syndrome

OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

Start date: March 11, 2024
Phase: Phase 3
Study type: Interventional

To evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS

NCT ID: NCT06242535 Active, not recruiting - Obesity Clinical Trials

Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity

Start date: July 27, 2023
Phase: Early Phase 1
Study type: Interventional

A combination of generally regarded as safe (GRAS) compounds named GLY-LOW, which included: alpha lipoic acid, pyridoxamine, nicotinamide, piperine and thiamine, were examined in pre-clinical experiments. GLY-LOW supplementation reduced caloric intake and increased insulin sensitivity in mice. In female mice, GLY-LOW supplementation reversed aging-related declines in female hormones. Studies in humans are needed to examine the feasibility, utility and efficacy of GLY-LOW supplementation in post-menopausal women with obesity toward improving aging-related impairments. The effect of GLY-LOW supplementation on these obesity and biological age-related impairments in post-menopausal adult female humans with obesity is unknown. We aim to translate the findings of GLY-LOW supplementation in animals to a cohort of healthy, postmenopausal females at birth with obesity by conducting a one-group, no-placebo comparer, pre post intervention clinical trial. Additionally, we propose to examine the specific effect of supplementation by GLY-LOW on biological aging via retina scan. The objectives of the proposed pilot study are: I. Conduct a 6-month pilot study to examine the feasibility, utility and efficacy of GLY-LOW supplementation in a total of 40 postmenopausal female born adults > 55 years with obesity (> 30 BMI) Ia. Examine alterations in self-reported caloric intake and the following health and biological aging, parameters prior to and after 6 months of GLY-LOW supplementation: 1. Self-reported Caloric Intake 2. Metabolic disease risk 3. Cardiovascular disease risk 4. Metabolic assessments 5. Hormones 6. Physical Function and Fitness 7. Muscular strength 8. Cognitive Function and Depression assessments 9. Systemic inflammation 10. Biological aging 11. Safety parameters (also every 2 months during the intervention; ECG at baseline and 2 months only) 12, Compliance measures (pill counts and interviews every 2 months during the intervention)

NCT ID: NCT06239064 Recruiting - Clinical trials for Cognitive Impairment

Early Genetic Identification of Obesity

WEGIO
Start date: January 24, 2024
Phase:
Study type: Observational

TITLE: Whole genetic approach in Early Genetic Identification of Obesity (WEGIO) DESIGN: Multicenter epidemiological study STUDY POPULATION: Participants at risk for a syndromic or a monogenic genetic obesity, incl. participants clinically diagnosed with Bardet-Biedl-Syndrome (BBS) NUMBER OF PARTICIPANTS: 1000 for initial genetic sequencing and app. 40 for the follow-up documentation COORDINATING INVESTIGATOR: Prof. Dr. Arndt Rolfs

NCT ID: NCT06173531 Recruiting - Clinical trials for Hyperphagia in Prader-Willi Syndrome

Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

Start date: November 27, 2023
Phase: Phase 3
Study type: Interventional

12-week, randomized, double-blind, placebo-controlled, parallel-group study of carbetocin nasal spray for the treatment of hyperphagia in Prader-Willi syndrome (PWS)

NCT ID: NCT05939453 Recruiting - Body Weight Clinical Trials

Impact of Bright Light Therapy on Prader-Willi Syndrome

PWS-LT
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome

NCT ID: NCT05804019 Recruiting - Clinical trials for Overweight, Obesity and Other Hyperalimentation

Nutritional and Physical Activities for Overweight and Obese Older Adults

IFEBO
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized trial is to test nutrition and exercise interventions in older adults in nursing homes. The main question it aims to answer are: • What effect do nutrition and physical interventions have on physical function and quality of life in older adults with overweight or obesity? Participants' data on body composition, physical function, and diseases will be collected. Furthermore, participants will be interviewed for a questionnaire on quality of life and nutritional intake. Researchers will compare three intervention nursing homes with three control nursing homes to see if nutrition and physical interventions have on physical function and quality of life.

NCT ID: NCT05676229 Recruiting - Obesity Clinical Trials

Probiotic Blend in Reducing Anthropometric Measurements in Obese Adults

Start date: January 11, 2023
Phase: Phase 2
Study type: Interventional

It is already known that dysbiosis, that is, qualitative and quantitative changes in the composition of the intestinal microbiota, can be associated with the development of a series of intestinal and extra-intestinal disorders. Dysbiosis is reported in irritable bowel syndrome, inflammatory bowel disease, colorectal cancer, allergic diseases, non-alcoholic steatohepatitis, arteriosclerotic diseases, neurological diseases and metabolic syndromes, mainly diabetes and obesity. Among the many factors that play a key role in obesity, a number of studies show the intestinal microbiota as an important contributor. Many studies carried out with probiotics have shown that their administration can be effective in the prevention and treatment of obesity. Furthermore, it is found that benefits for body weight, abdominal adiposity, anthropometric measurements and body composition are often associated with favorable metabolic effects.

NCT ID: NCT05541003 Completed - Obesity Clinical Trials

Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome

PWSGUT
Start date: January 6, 2023
Phase: Phase 2
Study type: Interventional

This study aims to use a high-fiber supplementation, an intervention known to create shifts in the gut microbiota towards a healthier structure, to explore the relationship between gut microbiota, appetite control and feeding behavior in PWS patients.

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: NCT05200182 Recruiting - Hyperphagia Clinical Trials

fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating

Cemov
Start date: April 7, 2022
Phase: N/A
Study type: Interventional

Emotional overeating is characterized by an excessive food intake in the context of intense emotional situations, such as acute stress one. Emotional overeating, as a behavioral trait, can increase the risk of to develop eating disorders or eating-related diseases, such as metabolic syndrome, obesity, type-2 diabetes. Recently, imaging modalities, such as magnetic resonance imaging (MRI) and electro-encephalography (EEG), have been adapted in order to perform neurofeedback consisting on presenting the brain activity instantaneously to the participant, that give him the possibility to modify this activity by his own mean. Neurofeedback has already shown some efficacy, either with explicit or implicit instruction. Compared with functional MRI (fMRI), functional near infra-red spectroscopy (fNIRS) is easy to handle, less expensive, and does not require a lying position. fNIRS is consequently more adapted for repeated acquisitions. Neurofeedback has already shown some promising results for neurological and psychiatric diseases. For mental states and emotion regulation, neurofeedback targeting the prefrontal cortex (PFC) has also shown promising outcomes. In this project, the investigators want to assess the effect of neurofeedback targeting the dorsolateral PFC (dlPFC) in a population of young adult women presenting emotional overeating. The investigators aim to improve the cognitive control and to reduce the episodes of emotional overeating in order to prevent the occurrence of subsequent pathologies. The intervention effect will be characterized with: (i) fMRI in order to evaluate the effect on cognitive control (with resting state fMRI or rsMRI) and on the reward system; (II) questionaries directly and one month after intervention in order to assess the behavioral effect. Besides an expected effect on emotional overeating, the investigators will evaluate whether an improvement of cognitive control can also promote positive effect on other behavioral traits that could lead to some pathologies such as food addiction. As a prerequisite to this study on emotional overeating (study B), the investigators will firstly validate on healthy subjects (study A) a reward anticipation fMRI task, which will be further used in study A in order to characterized the effect of neurofeedback on the reward system.