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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Diet
BehavioralA reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
Health Education
BehavioralMonthly health education sessions delivered remotely.
Treatment groups
81 Participants
are divided into 2 treatment groupsGroup A: Weight LossExperimental treatment 2 interventions
Group B: General Health Education ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
Neurofilament light
Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.
Time frame
Baseline, 6, 12 months3
Weight
Examines how much a person weights, measured by standing on a scale.
Time frame
Baseline, 6, 12 monthsSecondary outcomes
1
Dietary Intake
Examines what someone is eating, measured by writing down what a person eats over 3 days.
Time frame
Baseline, 6, 12 months2
Skin carotenoid content
Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter.
Time frame
Baseline, 6, 12 months3
Plasma Phosphorylated Tau
Examines the amount of Tau in a person's brain, collected by a blood draw.
Time frame
Baseline, 6, 12 months4
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 monthsOther outcomes
1
Height
Examines how tall a person is, measured on a stadiometer
Time frame
Baseline, 6, 12 months2
Waist circumference
Examines the distance around the smallest part of a person's torso, measured with a measuring tape
Time frame
Baseline, 6, 12 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov