Brain Outcomes With Lifestyle Change in Down Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Diagnosis of dementia
Insulin dependent diabetes
Participation in a weight management program involving diet or physical activity in the past 6 mos.
Dairy allergy
Trial design
Treatments tested in this trial
- Diet
- Health Education
Treatment groups
81 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov