Brain Outcomes With Lifestyle Change in Down Syndrome

Obesity Clinical Trial

— BOLD  

Official title:

The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05985486
• Other study ID #: Study 150542
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: September 30, 2027

Study information

• Verified date: November 2023
• Source: University of Kansas Medical Center
• Contact: Lauren Ptomey, PhD
• Phone: 913-588-7982
• Email: lptomey[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to determine if weight loss or changes 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 81
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Down syndrome

• BMI of 25 to 45 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Down Syndrome
• Obesity
• Syndrome

Intervention

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.
• Health Education
Monthly health education sessions delivered remotely.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Height	Examines how tall a person is, measured on a stadiometer	Baseline, 6, 12 months
Other	Waist circumference	Examines the distance around the smallest part of a person's torso, measured with a measuring tape	Baseline, 6, 12 months
Other	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.	Across 12 months
Other	Compliance with self-monitoring of diet	Assessed as the percentage of days a person tracked what they ate across the study.	Across 12 months
Other	Physical Activity	Examines Daily minutes of light, moderate, and vigorous physical activity as well as sedentary time using an ActiGraph tri-axial accelerometer worn on a wrist for 7 days.	Baseline, 6, 12 months
Other	Structured interviews	A 20% random sample of participants and study partners from each intervention arm will complete a 30 minute interview to gather information that might be useful for improving the intervention.	12 months
Primary	Plasma Amyloid beta 42:40 ratio	Examines the amount of amyloid beta in a person's brain, measured by a blood draw.	Baseline, 6, 12 months
Primary	Neurofilament light	Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.	Baseline, 6, 12 months
Primary	Weight	Examines how much a person weights, measured by standing on a scale.	Baseline, 6, 12 months
Secondary	Cognitive Function	Examines cognitive function measured using the National Alzheimer's Coordinating Center's DS Module.	Baseline, 6, 12 months
Secondary	Brian Volume	Examines how much white and grey matter a person has in their brain, measured by MRI	Baseline, 6, 12 months
Secondary	Brain antioxidants	Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI	Baseline, 6, 12 months
Secondary	Dietary Intake	Examines what someone is eating, measured by writing down what a person eats over 3 days.	Baseline, 6, 12 months
Secondary	Skin carotenoid content	Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter.	Baseline, 6, 12 months
Secondary	Plasma Phosphorylated Tau	Examines the amount of Tau in a person's brain, collected by a blood draw.	Baseline, 6, 12 months
Secondary	Glial Fibrillary Acidic Protein	Examines the amount of Glial Fibrillary Acidic Protein in a person's brain, collected by a blood draw.	Baseline, 6, 12 months