An interventional study of Diet and Health Education in Down Syndrome, Alzheimer Disease and Obesity, sponsored by University of Kansas Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention
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.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
This study's planned enrollment of 81 is above the median of 37 across 286 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Follow a reduced calorie diet daily for 12 months. * Attend monthly behavioral counseling/education
Behavioral: Diet · Behavioral: Health Education
\- Attend monthly health education sessions about general health.
Behavioral: Health Education
A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
Monthly health education sessions delivered remotely.
Plasma Amyloid beta 42:40 ratio
Examines the amount of amyloid beta in a person's brain, measured by a blood draw.
Time frame: Baseline, 6, 12 months
Neurofilament light
Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.
Time frame: Baseline, 6, 12 months
Weight
Examines how much a person weights, measured by standing on a scale.
Time frame: Baseline, 6, 12 months
Dietary Intake
Examines what someone is eating, measured by writing down what a person eats over 3 days.
Time frame: Baseline, 6, 12 months
Skin carotenoid content
Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter.
Time frame: Baseline, 6, 12 months
Plasma Phosphorylated Tau
Examines the amount of Tau in a person's brain, collected by a blood draw.
Time frame: Baseline, 6, 12 months
Glial Fibrillary Acidic Protein
Examines the amount of Glial Fibrillary Acidic Protein in a person's brain, collected by a blood draw.
Time frame: Baseline, 6, 12 months
Brian Volume
Examines how much white and grey matter a person has in their brain, measured by MRI
Time frame: Baseline, 12 months
Brain antioxidants
Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI
Time frame: Baseline, 12 months
The modified Cued Recall Test
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.
Time frame: Baseline, 6, 12 months
The Modified Cats and Dogs Task
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").
Time frame: Baseline, 6, 12 months
Down Syndrome Mental Status Examination
Provides an omnibus measure of neuropsychological functioning, assessing recall of personal information, orientation, immediate and delayed memory, language, visuospatial function and praxis.
Time frame: Baseline, 6, 12 months
Height
Examines how tall a person is, measured on a stadiometer
Time frame: Baseline, 6, 12 months
Waist circumference
Examines the distance around the smallest part of a person's torso, measured with a measuring tape
Time frame: Baseline, 6, 12 months
Attendance at education sessions
Examines how often individuals attendance the monthly education sessions. Obtained from interventionist records and expressed as the percentage of possible sessions attended.
Time frame: Across 12 months
Compliance with self-monitoring of diet
Assessed as the percentage of days a person tracked what they ate across the study.
Time frame: Across 12 months
Physical Activity
Examines Daily minutes of light, moderate, and vigorous physical activity as well as sedentary time using an ActiGraph tri-axial accelerometer worn on a wrist for 7 days.
Time frame: Baseline, 6, 12 months
Structured interviews
A 20% random sample of participants and study partners from each intervention arm will complete a 30 minute interview to gather information that might be useful for improving the intervention.
Time frame: 12 months
Plan to share: No
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