Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Location status: Recruiting
NCT Number: NCT06511310
This study aims to explore how HIIT influences brain function, neural and molecular pathways related to weight control, setting the stage for future obesity intervention research.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
Location status: Recruiting
This study will include adults aged 18-70 years with a BMI >19 kg/m², both with and without prior bariatric surgery. Those with bariatric surgery must have experienced clinically significant weight regain (>10% of maximum weight lost) within 1 to 5 years post-surgery.
Participants will complete three initial clinical visits before beginning a 12-week high-intensity interval training (HIIT) program, followed by three post-training clinical visits. During visit 1, participants will undergo anthropometric assessments, baseline blood draw, oral glucose tolerance test, psychometric evaluations, and complete an MRI safety screening. At visit 2, participants will complete a resting metabolic rate assessment and a VO₂peak test. During visit 3, participants will have another baseline blood draw and undergo a functional MRI (fMRI).
The HIIT program will consist of four weekly 28-minute sessions conducted at the Joslin Diabetes and at home. Each exercise session will include a 3-minute warm-up, six rounds of 40 seconds high-intensity followed by 3 minutes of moderate intensity, and will conclude with a 3-minute cool-down.
After completing the 12-week program, participants will return for clinical visits 4-6, repeating all baseline assessments.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High Intensity Exercise
Time frame: Evaluation of changes in brain function by fMRI before and after 12 weeks of exercise training.
Time frame: Evaluation of changes in hunger before and after 12 weeks of exercise training.
Subjects will be evaluated with Three Factor Eating Questionnaire (TFEQ).
Time frame: Evaluation of changes in mood before and after 12 weeks of exercise training.
Subjects will be evaluated with Beck Depression Inventory II (BDI-II) to assess for depressive symptoms.
Time frame: Evaluation of changes in miRNA before and after 12 weeks of exercise training.
Changes in circulating exosome miRNAs will be measured using next-generation sequencing (NGS) and reported as normalized counts or fold changes relative to baseline.
Time frame: Changes in cognition function before and after 12 weeks of HIIT.
Evaluation using mini cognitive test.
Contact information is provided by the study sponsor or research team.
Laura Simpson, MS
CONTACT
Maria Vamvini, MD
CONTACT
Joslin Diabetes Center
Other
Effects of Exercise Training on Brain Activity and Its Relation to Weight Maintenance and Appetite Regulation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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