What this study is
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.
What's being tested
- Diet
Intervention · BEHAVIORAL
A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
- Health Education
Intervention · BEHAVIORAL
Monthly health education sessions delivered remotely.
Study details
- Official title
- The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome
- Sponsor
- University of Kansas Medical Center
- Conditions
- Down Syndrome · Alzheimer Disease · Obesity
- Enrolling
- 81 people
- Starts
- 2024-10-22
- Est. completion
- 2027-09-30
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 64 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Kansas Medical Center
Kansas City, Kansas, United States
- Lauren Ptomey, PhD · Contact
Recruiting
Study team
Sponsor
University of Kansas Medical Center
Study ID Study 150542
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.