Brain Outcomes With Lifestyle Change in Down Syndrome

Last updated: May 15, 2025
Sponsor: University of Kansas Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Down's Syndrome

Treatment

Diet

Health Education

Clinical Study ID

NCT05985486
Study 150542
  • Ages 18-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 foroutcomes testing

  • Living at home with a parent/guardian, or in a supported living environment with acaregiver who assists with food shopping, meal planning, and meal preparation andagrees to serve as a study partner including providing transportation to ourfacilities for study assessments.

Exclusion

Exclusion Criteria:

  • Diagnosis of dementia

  • Insulin dependent diabetes

  • Participation in a weight management program involving diet or physical activity inthe 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 MRIsuch as pacemakers, claustrophobia, and inability to lay in a supine position

  • Use of GLP-1 medications

  • Use of anti-amyloid medications

Study Design

Total Participants: 81
Treatment Group(s): 2
Primary Treatment: Diet
Phase:
Study Start date:
October 22, 2024
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

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