Alzheimer Disease, Down Syndrome, Obesity
Conditions
Brief 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.
Interventions
BEHAVIORALDiet
A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
BEHAVIORALHealth Education
Monthly health education sessions delivered remotely.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Amyloid beta 42:40 ratio | Baseline, 6, 12 months | Examines the amount of amyloid beta in a person's brain, measured by a blood draw. |
| Neurofilament light | Baseline, 6, 12 months | Examines the amount of Neurofilament light in a person's brain, measured by a blood draw. |
| Weight | Baseline, 6, 12 months | Examines how much a person weights, measured by standing on a scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Intake | Baseline, 6, 12 months | Examines what someone is eating, measured by writing down what a person eats over 3 days. |
| Skin carotenoid content | Baseline, 6, 12 months | Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter. |
| Plasma Phosphorylated Tau | Baseline, 6, 12 months | Examines the amount of Tau in a person's brain, collected by a blood draw. |
| Glial Fibrillary Acidic Protein | Baseline, 6, 12 months | Examines the amount of Glial Fibrillary Acidic Protein in a person's brain, collected by a blood draw. |
| Brian Volume | Baseline, 12 months | Examines how much white and grey matter a person has in their brain, measured by MRI |
| Brain antioxidants | Baseline, 12 months | Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI |
| The modified Cued Recall Test | Baseline, 6, 12 months | Measures cognitive function. Twelve items are presented for learning, 4 at a time, with each item accompanied by a unique category cue. The testing phase consists of 3 trials. Each trial begins with free recall of the test items; following free recall, a category cue is provided for those items not spontaneously recalled. |
| The Modified Cats and Dogs Task | Baseline, 6, 12 months | Measures executive function. The task measures the ability to inhibit a natural response (naming the pictures of a dog, as "dog") and to replace it with an incongruent one (naming the pictures of a dog as "cat"). |
| Down Syndrome Mental Status Examination | Baseline, 6, 12 months | Provides an omnibus measure of neuropsychological functioning, assessing recall of personal information, orientation, immediate and delayed memory, language, visuospatial function and praxis. |
Countries
United States
Contacts
CONTACTLauren Ptomey, PhD
CONTACTJessica Danon
Outcome results
None listed