Brain Outcomes With Lifestyle Change in Down Syndrome

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT05985486
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Diet — 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 — BEHAVIORAL
    Monthly health education sessions delivered remotely.

Study Details

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.

Key Dates

Start date
Oct 22, 2024
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
81 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Weight Loss
    * Follow a reduced calorie diet daily for 12 months. * Attend monthly behavioral counseling/education
  • Active Comparator: General Health Education Control
    \- Attend monthly health education sessions about general health.

Primary Outcome Measure

Plasma Amyloid beta 42:40 ratio [ Time Frame: Baseline, 6, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
Lauren Ptomey, PhD

Find similar trials in Kansas City, KS

By condition
Alzheimer's diseaseObesity / overweight
By specialty
NeurologyDementia careBrain disordersGeriatricsEndocrinologyMetabolic healthWeight loss
By research site
University of Kansas Medical Center· Kansas City, KS

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