Exercise, Brain Activity, and Weight Maintenance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJoslin Diabetes Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-70 years
Body mass index (BMI) >19 kg/m2 and body weight< 250kg
Participants must have experienced a clinically significant weight regain, defined as over 10% of their maximum weight lost, within 1 to 5 years following their bariatric surgery. They will be asked to self-report their weight loss history. Participants must also provide the operative report from their bariatric surgery for reference.
In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
Disqualifiers
Type 1 diabetes mellitus
Peripheral neuropathy with insensate feet
Recent blood donation within the last 2 months
Use of beta-blockers
Trial design
Design model
Single group
Treatments tested in this trial
Exercise
Other interventionHigh Intensity Exercise
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Exercise TrainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in connectivity between brain areas following exercise training by using resting state functional MRI.
Time frame
Evaluation of changes in brain function by fMRI before and after 12 weeks of exercise training.Secondary outcomes
1
Changes in appetitive behavior.
Subjects will be evaluated with Three Factor Eating Questionnaire (TFEQ).
Time frame
Evaluation of changes in hunger before and after 12 weeks of exercise training.2
Changes in mood.
Subjects will be evaluated with Beck Depression Inventory II (BDI-II) to assess for depressive symptoms.
Time frame
Evaluation of changes in mood before and after 12 weeks of exercise training.3
Degree of changes in miRNA profiling of circulating exosomes in blood samples.
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
Evaluation of changes in miRNA before and after 12 weeks of exercise training.4
Changes in cognitive function.
Evaluation using mini cognitive test.
Time frame
Changes in cognition function before and after 12 weeks of HIIT.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Joslin Diabetes Center
Lead sponsor
Nutrition Obesity Research Center
Collaborator
Source ClinicalTrials.gov