Brain Outcomes With Lifestyle Change in Down Syndrome

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Aug 2, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Brain Outcomes With Lifestyle Change in Down Syndrome," is studying whether weight loss can help adults with Down syndrome delay or prevent the development of Alzheimer's disease. Participants in the study will be divided into two groups: one group will focus on losing weight through a special diet and monthly online education sessions, while the other group will receive general health information without a weight loss focus. The goal is to see if these lifestyle changes can positively impact brain health.

To join the study, participants must have a diagnosis of Down syndrome and a body mass index (BMI) between 25 and 45, which indicates they may be overweight. They should be able to communicate verbally and attend three visits to the University of Kansas Medical Center over a year for various tests, including blood draws and brain scans. It’s important to note that those with dementia or certain medical conditions won't be eligible. This study offers a chance to contribute to research that could improve health outcomes for individuals with Down syndrome while also providing support and education on healthy living.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of Down syndrome
• • BMI of 25 to 50 kg/m2
• • Ability to communicate through spoken language.
• • Ability to come to the University of Kansas Medical Center 3 times across 1 year for outcomes testing
• • Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner including providing transportation to our facilities for study assessments.
• Exclusion Criteria:
• • Diagnosis of dementia
• • Insulin dependent diabetes
• • Participation in a weight management program involving diet or physical activity in the past 6 mos.
• • Dairy allergy
• • Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)
• • Unwilling to be randomized
• • Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position
• • Use of GLP-1 medications
• • Use of anti-amyloid medications