Exercise, Brain Activity, and Weight Maintenance

NCT06511310 | Recruiting

• 1 other identifier: 00000256
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Weight Gain; Bariatric Surgery Candidate; Appetitive Behavior

Outcome Measures

Primary Outcomes (1)

• Changes in connectivity between brain areas following exercise training by using resting state functional MRI.

  Evaluation of changes in brain function by fMRI before and after 12 weeks of exercise training.

Secondary Outcomes (4)

• Changes in appetitive behavior.

  Evaluation of changes in hunger before and after 12 weeks of exercise training.

• Changes in mood.

  Evaluation of changes in mood before and after 12 weeks of exercise training.

• Degree of changes in miRNA profiling of circulating exosomes in blood samples.

  Evaluation of changes in miRNA before and after 12 weeks of exercise training.

• Changes in cognitive function.

  Changes in cognition function before and after 12 weeks of HIIT.

Study Arms (1)

Exercise Training

EXPERIMENTAL

Subjects will complete a supervised high-intensity interval training program for 12 weeks, including four weekly training sessions. The training session will include a 3 minute warm-up followed by six 40 second bouts of high intensity (85-95% of VO2peak) with 3 minutes moderate intensity (45-55% of VO2peak) between each bout of high intensity, concluding with a 3 minute cool-down. Each participant's target heart rate will be specific to them, calculated from the exercise test completed during Visit 1.

Other: Exercise

Interventions

Exercise OTHER

High Intensity Exercise

Exercise Training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willing to adhere to the protocol requirements for the duration of the study

You may not qualify if:

• Type 1 diabetes mellitus
• Peripheral neuropathy with insensate feet
• Recent blood donation within the last 2 months
• Use of beta-blockers
• Current pregnancy or breastfeeding
• Active Heart or lung disease
• Severe hypertension (systolic \>160 mmHg or diastolic \>90 mmHg)
• Inability to exercise for any reason
• Any known contraindication to exercise testing based on current ACSM guidelines
• MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
• Known presence of a structural brain lesion (e.g. tumor, cortical infarct)
• Presence of another neurologic disorder, which could impact findings (e.g. multiple sclerosis)
• History of cardiovascular disease, stroke, congestive heart failure
• Active hematological, renal, pulmonary or hepatic disorders
• Active treatment for cancer

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Nutrition Obesity Research Center: collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Gain; Appetitive Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maria Vamvini, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Vamvini, MD

CONTACT

617-309-2400; Maria.Vamvini@joslin.harvard.edu

Laura Simpson, MS

CONTACT

617-735-3924; laura.simpson@joslin.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 19, 2024
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)