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NCT Number: NCT05985486

Brain Outcomes With Lifestyle Change in Down Syndrome

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Alzheimer Disease Body Weight Brain Diseases Central Nervous System Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Genetic Diseases, Inborn Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location status: Recruiting

Location contact

Lauren Ptomey, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Behavioral

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

Behavioral

Monthly health education sessions delivered remotely.

Primary outcomes

  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 outcomes

  1. Dietary Intake

    Time frame: Baseline, 6, 12 months

    Examines what someone is eating, measured by writing down what a person eats over 3 days.

  2. 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.

  3. Plasma Phosphorylated Tau

    Time frame: Baseline, 6, 12 months

    Examines the amount of Tau in a person's brain, collected by a blood draw.

  4. 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.

  5. Brian Volume

    Time frame: Baseline, 12 months

    Examines how much white and grey matter a person has in their brain, measured by MRI

  6. Brain antioxidants

    Time frame: Baseline, 12 months

    Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI

  7. The modified Cued Recall Test

    Time frame: Baseline, 6, 12 months

    Measures cognitive function. Twelve items are presented for learning, 4 at a time, with each item accompanied by a unique category cue. The testing phase consists of 3 trials. Each trial begins with free recall of the test items; following free recall, a category cue is provided for those items not spontaneously recalled.

  8. The Modified Cats and Dogs Task

    Time frame: Baseline, 6, 12 months

    Measures executive function. The task measures the ability to inhibit a natural response (naming the pictures of a dog, as "dog") and to replace it with an incongruent one (naming the pictures of a dog as "cat").

  9. Down Syndrome Mental Status Examination

    Time frame: Baseline, 6, 12 months

    Provides an omnibus measure of neuropsychological functioning, assessing recall of personal information, orientation, immediate and delayed memory, language, visuospatial function and praxis.

Other outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Danon

CONTACT

[email protected]

785-764-3574

Lauren Ptomey, PhD

CONTACT

[email protected]

913-588-7982

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Acronym: BOLD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2023
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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