RECRUITING

Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to investigate how gut hormones and brain areas respond differently to gastric distention, tasteless calories, or palatable food and how this alters appetite.

Official Title

Physiological Regulation of Energy Intake - The FOOD-PRINT Study Identifying the Hormonal and Neural Footprints of the Visceroceptive, Homeostatic, and Hedonic Components of Food Intake Regulation in Humans

Quick Facts

Study Start:2022-09-08

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05525845

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* BMI 18-25 kg/m\^2. * Weight stable for 3 months prior to study entry. * For females: study days will be scheduled during the follicular phase of their menstrual cycle (i.e., the first 13 days (about 2 weeks) of the cycle). * Able to provide written informed consent prior to any study procedures and be willing and able to follow study procedures.. * Ability to perform light to moderate physical activity.	* Any contraindication for MRI scanning. * Any history of childhood (\> 95th percentile) or adult obesity (BMI \>30 kg/m\^2). * Claustrophobia. * High intensity training or physical activity. * Any contraindication for intragastric balloon insertion. * Any allergies to the study meals. * Any history of eating disorder. * Any substance abuse disorder (including alcohol and tobacco). * Any history of psychiatric disorders. * Any cardiovascular, endocrine, pulmonary, neurological, or gastrointestinal comorbidities. * Pregnancy or nursing. * Any history of bariatric surgery or endoscopic bariatric procedure. * Use of any medication or supplement that alters appetite. * Patient has a known history of any condition or factor judged by the investigator to prevent participation in the study or which might hinder study adherence.

Inclusion Criteria

Exclusion Criteria

* BMI 18-25 kg/m\^2.
* Weight stable for 3 months prior to study entry.
* For females: study days will be scheduled during the follicular phase of their menstrual cycle (i.e., the first 13 days (about 2 weeks) of the cycle).
* Able to provide written informed consent prior to any study procedures and be willing and able to follow study procedures..
* Ability to perform light to moderate physical activity.

* Any contraindication for MRI scanning.
* Any history of childhood (\> 95th percentile) or adult obesity (BMI \>30 kg/m\^2).
* Claustrophobia.
* High intensity training or physical activity.
* Any contraindication for intragastric balloon insertion.
* Any allergies to the study meals.
* Any history of eating disorder.
* Any substance abuse disorder (including alcohol and tobacco).
* Any history of psychiatric disorders.
* Any cardiovascular, endocrine, pulmonary, neurological, or gastrointestinal comorbidities.
* Pregnancy or nursing.
* Any history of bariatric surgery or endoscopic bariatric procedure.
* Use of any medication or supplement that alters appetite.
* Patient has a known history of any condition or factor judged by the investigator to prevent participation in the study or which might hinder study adherence.

Contacts and Locations

Study Contact

Megan Schaefer

CONTACT

507-266-6004

RSTINDIVOBESITY@mayo.edu

Principal Investigator

Andres Acosta, MD, PhD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Andres Acosta, MD, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-08

Study Completion Date2025-08

Study Record Updates

Study Start Date2022-09-08

Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

Healthy