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Brain Outcomes With Lifestyle Change in Down Syndrome (BOLD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05985486
Recruitment Status : Not yet recruiting
First Posted : August 14, 2023
Last Update Posted : November 29, 2023
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Down Syndrome Alzheimer Disease Obesity Behavioral: Diet Behavioral: Health Education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome
Estimated Study Start Date : October 1, 2024
Estimated Primary Completion Date : September 30, 2027
Estimated Study Completion Date : September 30, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Weight Loss
  • Follow a reduced calorie diet daily for 12 months.
  • Attend monthly behavioral counseling/education
 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.

Behavioral: Health Education
Monthly health education sessions delivered remotely.
Active Comparator: General Health Education Control
- Attend monthly health education sessions about general health.
 Behavioral: Health Education
Monthly health education sessions delivered remotely.


Outcome Measures
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Primary Outcome Measures :
  1. Plasma Amyloid beta 42:40 ratio [ Time Frame: Baseline, 6, 12 months ]
    Examines the amount of amyloid beta in a person's brain, measured by a blood draw.

  2. Neurofilament light [ Time Frame: Baseline, 6, 12 months ]
    Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.

  3. Weight [ Time Frame: Baseline, 6, 12 months ]
    Examines how much a person weights, measured by standing on a scale.


Secondary Outcome Measures :
  1. Cognitive Function [ Time Frame: Baseline, 6, 12 months ]
    Examines cognitive function measured using the National Alzheimer's Coordinating Center's DS Module.

  2. Brian Volume [ Time Frame: Baseline, 6, 12 months ]
    Examines how much white and grey matter a person has in their brain, measured by MRI

  3. Brain antioxidants [ Time Frame: Baseline, 6, 12 months ]
    Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI

  4. Dietary Intake [ Time Frame: Baseline, 6, 12 months ]
    Examines what someone is eating, measured by writing down what a person eats over 3 days.

  5. Skin carotenoid content [ Time Frame: Baseline, 6, 12 months ]
    Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter.

  6. Plasma Phosphorylated Tau [ Time Frame: Baseline, 6, 12 months ]
    Examines the amount of Tau in a person's brain, collected by a blood draw.

  7. Glial Fibrillary Acidic Protein [ Time Frame: Baseline, 6, 12 months ]
    Examines the amount of Glial Fibrillary Acidic Protein in a person's brain, collected by a blood draw.


Other Outcome Measures:
  1. Height [ Time Frame: Baseline, 6, 12 months ]
    Examines how tall a person is, measured on a stadiometer

  2. Waist circumference [ Time Frame: Baseline, 6, 12 months ]
    Examines the distance around the smallest part of a person's torso, measured with a measuring tape

  3. Attendance at education sessions [ Time Frame: Across 12 months ]
    Examines how often individuals attendance the monthly education sessions. Obtained from interventionist records and expressed as the percentage of possible sessions attended.

  4. Compliance with self-monitoring of diet [ Time Frame: Across 12 months ]
    Assessed as the percentage of days a person tracked what they ate across the study.

  5. Physical Activity [ Time Frame: Baseline, 6, 12 months ]
    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.

  6. Structured interviews [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05985486


Contacts
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Contact: Lauren Ptomey, PhD 913-588-7982 lptomey@kumc.edu
Contact: Jessica Danon 785-764-3574 jdanon@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
More Information
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT05985486    
Other Study ID Numbers: Study 150542
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: November 29, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Down Syndrome
Syndrome
Disease
Pathologic Processes
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn