Diet and Cognitive Training in Hematologic Cancer Survivors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05708716
Status
Recruiting
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Conditions

  • Cognitive Impairment
  • Hematologic Malignancy

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modified ketogenic diet using an exogenous ketogenic formula — BEHAVIORAL
    Participants will follow a modified ketogenic diet consuming a daily exogenous ketogenic meal replacement formula while limiting their carbohydrate intake for 12 weeks.
  • Online cognitive training — BEHAVIORAL
    Participants will complete a daily session of 5 online cognitive training tasks for 12 weeks.

Study Details

The goal of this clinical trial is to examine feasibility of a cognitive intervention program in blood cancer survivors. The main questions it aims to answer are: * is it feasible to combine a ketogenic diet supplementation and online cognitive training in an intervention program * will patients using the combined intervention program have improved cognitive functioning compared to those who don't use it * how long will the intervention programs effects last Participants randomized to the intervention arm will consume an exogenous ketogenic supplementation and use an online cognitive training program for 12 weeks, while waitlist arm functions as a control group and will receive the online cognitive training only after a wait period of 12 weeks. Researchers will compare the intervention and waitlist control groups to see if the intervention improves cognitive functioning.

Key Dates

Start date
Nov 22, 2022
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Diet and Cognitive Training
    The arm will follow a modified ketogenic diet using an exogenous ketogenic formula (KetoCal) and use the online cognitive training program Lumosity at time of enrollment on the study.
  • Active Comparator: WaitList Control
    The arm will only use the online cognitive training program Lumosity 3 months after enrollment in the study.

Primary Outcome Measure

Number of hematologic malignancy patients completing the 2-arm 12wk randomized wait-listed trial of the multicomponent intervention of modified ketogenic diet and cognitive training [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Noha Sharafeldin, MD, MSc, PhD
[email protected]
2056382144
Lindsey Hageman, MPH, CCRP
[email protected]
2056382139

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By research site
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