Back to resultsBrain Outcomes With Lifestyle Change in Down Syndrome (BOLD)
Primary Purpose
Down Syndrome, Alzheimer Disease, Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet
Health Education
Sponsored by
About this trial
This is an interventional prevention trial for Down Syndrome
Eligibility Criteria
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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Weight Loss
General Health Education Control
Arm Description
Follow a reduced calorie diet daily for 12 months. Attend monthly behavioral counseling/education
- Attend monthly health education sessions about general health.
Outcomes
Primary Outcome Measures
Plasma Amyloid beta 42:40 ratio
Examines the amount of amyloid beta in a person's brain, measured by a blood draw.
Neurofilament light
Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.
Weight
Examines how much a person weights, measured by standing on a scale.
Secondary Outcome Measures
Cognitive Function
Examines cognitive function measured using the National Alzheimer's Coordinating Center's DS Module.
Brian Volume
Examines how much white and grey matter a person has in their brain, measured by MRI
Brain antioxidants
Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI
Dietary Intake
Examines what someone is eating, measured by writing down what a person eats over 3 days.
Skin carotenoid content
Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter.
Plasma Phosphorylated Tau
Examines the amount of Tau in a person's brain, collected by a blood draw.
Glial Fibrillary Acidic Protein
Examines the amount of Glial Fibrillary Acidic Protein in a person's brain, collected by a blood draw.
Full Information
NCT ID
NCT05985486
First Posted
August 2, 2023
Last Updated
August 2, 2023
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05985486
Brief Title
Brain Outcomes With Lifestyle Change in Down Syndrome
Acronym
BOLD
Official Title
The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2024 (Anticipated)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome, Alzheimer Disease, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Weight Loss
Arm Type
Experimental
Arm Description
Follow a reduced calorie diet daily for 12 months.
Attend monthly behavioral counseling/education
Arm Title
General Health Education Control
Arm Type
Active Comparator
Arm Description
- Attend monthly health education sessions about general health.
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Monthly health education sessions delivered remotely.
Primary Outcome Measure Information:
Title
Plasma Amyloid beta 42:40 ratio
Description
Examines the amount of amyloid beta in a person's brain, measured by a blood draw.
Time Frame
Baseline, 6, 12 months
Title
Neurofilament light
Description
Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.
Time Frame
Baseline, 6, 12 months
Title
Weight
Description
Examines how much a person weights, measured by standing on a scale.
Time Frame
Baseline, 6, 12 months
Secondary Outcome Measure Information:
Title
Cognitive Function
Description
Examines cognitive function measured using the National Alzheimer's Coordinating Center's DS Module.
Time Frame
Baseline, 6, 12 months
Title
Brian Volume
Description
Examines how much white and grey matter a person has in their brain, measured by MRI
Time Frame
Baseline, 6, 12 months
Title
Brain antioxidants
Description
Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI
Time Frame
Baseline, 6, 12 months
Title
Dietary Intake
Description
Examines what someone is eating, measured by writing down what a person eats over 3 days.
Time Frame
Baseline, 6, 12 months
Title
Skin carotenoid content
Description
Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter.
Time Frame
Baseline, 6, 12 months
Title
Plasma Phosphorylated Tau
Description
Examines the amount of Tau in a person's brain, collected by a blood draw.
Time Frame
Baseline, 6, 12 months
Title
Glial Fibrillary Acidic Protein
Description
Examines the amount of Glial Fibrillary Acidic Protein in a person's brain, collected by a blood draw.
Time Frame
Baseline, 6, 12 months
Other Pre-specified Outcome Measures:
Title
Height
Description
Examines how tall a person is, measured on a stadiometer
Time Frame
Baseline, 6, 12 months
Title
Waist circumference
Description
Examines the distance around the smallest part of a person's torso, measured with a measuring tape
Time Frame
Baseline, 6, 12 months
Title
Attendance at education sessions
Description
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 months
Title
Compliance with self-monitoring of diet
Description
Assessed as the percentage of days a person tracked what they ate across the study.
Time Frame
Across 12 months
Title
Physical Activity
Description
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.
Time Frame
Baseline, 6, 12 months
Title
Structured interviews
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Ptomey, PhD
Phone
913-588-7982
Email
lptomey@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Danon
Phone
785-764-3574
Email
jdanon@kumc.edu
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Brain Outcomes With Lifestyle Change in Down Syndrome
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