Brain Outcomes With Lifestyle Change in Down Syndrome (BOLD)

University of Kansas

Status: Enrolling

Conditions: Alzheimer Disease; Down Syndrome; Obesity

Treatments: Behavioral: Health Education; Behavioral: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05985486

Study 150542

Details and patient eligibility

About

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.

Enrollment: 81 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner including providing transportation to our facilities for study assessments.

Exclusion criteria

• Diagnosis of dementia
• Insulin dependent diabetes
• Participation in a weight management program involving diet or physical activity in the past 6 mos.
• Dairy allergy
• Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)
• Unwilling to be randomized
• Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position
• Use of GLP-1 medications
• Use of anti-amyloid medications

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 2 patient groups

Weight Loss

Experimental group

Description:

* Follow a reduced calorie diet daily for 12 months. * Attend monthly behavioral counseling/education

Treatment:

Behavioral: Diet

Behavioral: Health Education

General Health Education Control

Active Comparator group

Description:

- Attend monthly health education sessions about general health.

Treatment:

Behavioral: Health Education