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Brain Outcomes With Lifestyle Change in Down Syndrome

NCT05985486 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Down Syndrome
  • Alzheimer Disease
  • Obesity

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.

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05985486 on ClinicalTrials.gov