Recruiting

Diet & Cognitive Training

Sponsor:

University of Alabama at Birmingham

Code:

NCT05708716

Conditions

Cognitive Impairment

Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Modified ketogenic diet using an exogenous ketogenic formula

Online cognitive training

Study Details

Brief summary:

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.

Conditions

Cognitive Impairment

Hematologic Malignancy

Study ID

NCT05708716

Start date

Nov 22, 2022

Status verified date

Dec, 2025

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult with hematologic malignancy diagnosed at age ≥21 years
  • Outpatient at least 3 months from completion of blood or marrow transplant (BMT) or at least 6 months from diagnosis for patients not treated with BMT
  • Evidence of mild-to-moderate cognitive impairment using either the Modified Telephone Interview for Mild Cognitive Impairment (TICS-M) or PROMIS 8a short form raw score = 19 -37
  • Have daily access to an internet-connected home computer
  • Can fluently read and write in English
  • Can understand and sign the study-specific Informed Consent Form

Exclusion Criteria:

  • History of pre-existing neurological disorder or documented major psychiatric disorder
  • Significant auditory, visual, or motor impairments
  • History of color blindness
  • Participated in neuropsychological intervention within the past 6 months
  • Evidence of active chronic graft vs. host disease (GvHD) for allogeneic BMT
  • History of pre-existing metabolic disease
  • Allergies to soy or milk
  • Body Mass Index (BMI) ≤20

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Modified ketogenic diet using an exogenous ketogenic formula

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

Participants will complete a daily session of 5 online cognitive training tasks for 12 weeks.

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 ]
  • Change in cognitive function global deficit score (GDS) from baseline to 12 wks, comparing patients on the multicomponent active arm to the waitlist arm (prior to receiving cognitive training) [ Time Frame: Baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Noha M Sharafeldin, MD, MSc, PhD

2056382144nsharafeldin@uabmc.edu

Lindsey Hageman, MPH

2056382139lihageman@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Noha Sharafeldin, MD, MSc, PhD

2056382144nsharafeldin@uabmc.edu

Lindsey Hageman, MPH, CCRP

2056382139lihageman@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • Hematologic Cancer Survivors
  • Blood or Marrow Transplantation
  • Cognitive Training
  • Modified Ketogenic Diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-12-17.