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RECRUITING
NCT05985486
NA

Brain Outcomes With Lifestyle Change in Down Syndrome

Sponsor: University of Kansas Medical Center

View on ClinicalTrials.gov

Summary

The goal of this study is to determine if weight loss or changes in dietary intake can help prevent of delay adults with Down syndrome from developing Alzheimer's Disease Adults with Down syndrome without dementia will be randomized to either a weight loss group or a general health education control group. The weight loss group will be asked to follow a reduced energy diet, attend monthly education sessions delivered remotely and self-monitor diet and body weight using commercially available web-based applications. The control group will be asked to attend remotely delivered monthly education sessions on general health education topics. All participants will come to the University of Kansas Medical Center, 3 times across 12 months for a blood draw, cognitive testing, a MRI, assessment of height and weight, and assessment of diet intake.

Official title: The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2024-10-22

Completion Date

2027-09-30

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

BEHAVIORAL

Diet

A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.

BEHAVIORAL

Health Education

Monthly health education sessions delivered remotely.

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States