NCT05985486 · University of Kansas Medical Center
Brain Outcomes With Lifestyle Change in Down Syndrome
(BOLD)
What this study is about
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 randomly assigned to either a weight loss group or a general health education control group.
View original scientific description
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.
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.
Primary outcome measures
Plasma Amyloid beta 42:40 ratio
Time frame: Baseline, 6, 12 months
Examines the amount of amyloid beta in a person's brain, measured by a blood draw.
Neurofilament light
Time frame: Baseline, 6, 12 months
Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.
Weight
Time frame: Baseline, 6, 12 months
Examines how much a person weights, measured by standing on a scale.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Kansas City, Kansas
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations