An interventional study of Modified ketogenic diet using an exogenous ketogenic formula and Online cognitive training in Cognitive Impairment and Hematologic Malignancy, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Supportive care
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:
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.
The investigators propose using "off-the-shelf" products in a 12-week multicomponent cognitive intervention program to address the cognitive impairment in outpatient hematologic malignancy survivors. The program includes two components: i) A modified ketogenic diet using an exogenous ketogenic supplementation using the KetoCal product ([https://shop.myketocal.com/product/ketocal-41-lq]) and ii) online cognitive training using Lumosity program (http://www.lumosity.com/).
A ketogenic diet is characterized by high fat, moderate protein and very low carbohydrate intake. Participants will follow a modified ketogenic diet consuming exogenous Ketocal tetrapaks daily to substitute \~700 calories of their daily calorie needs and limit their carbohydrate intake while maintaining an eucaloric diet. The KetoCal is a nutritionally complete, ready-to-feed ketogenic meal replacement product. The study goal is to achieve safe and tolerable levels of mild nutritional ketosis (0.5-2mmol/L betahydroxybutyrate (BHB) blood concentration). Diet education will be provided to participants on how and when to consume the KetoCal formula, foods and beverages consistent with a ketogenic diet and foods and beverages to avoid, and how to measure the ketosis using a breathalyzer daily. Safety and Tolerability monitoring will occur by recording treatment-emergent and/or treatment-related adverse events, regular monitoring of weight and satiety levels, and routine laboratory testing using fasting blood samples at baseline and 12 weeks.
The Lumosity program offers over 60 tasks in game-like format that cover the main cognitive domains: processing speed, working memory, attention and executive function. Training will involve a daily session of 5 training tasks for 12 weeks. Each time the patient is logged in for a session, a customized report will be generated by the Lumosity program to capture performance information.
Participants' cognitive functioning will be assessed at baseline and 12 weeks using objectively measured cognitive function to estimate the preliminary efficacy of intervention program; and at 24 weeks to examine the sustained effects of the multi-component intervention program.
The findings from this project will inform a definitive phase III trial of a multi-component intervention to improve cognitive outcomes in patients with hematologic malignancy.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 80 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Modified ketogenic diet using an exogenous ketogenic formula · Behavioral: Online cognitive training
The arm will only use the online cognitive training program Lumosity 3 months after enrollment in the study.
Behavioral: Online cognitive training
Participants will follow a modified ketogenic diet consuming a daily exogenous ketogenic meal replacement formula while limiting their carbohydrate intake for 12 weeks.
Also known as: KetoCal
Participants will complete a daily session of 5 online cognitive training tasks for 12 weeks.
Also known as: Lumosity
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
Number of participants completing the 12 week intervention
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)
Change in cognitive function will be measured using the cognitive function global deficit score (GDS) at baseline and 12 weeks comparing both active and waitlist arms. The neuropsychological test battery will include the following tests: D-KEFS Verbal Fluency, DKEFS Color-Word Interference, D-KEFS Trail Making, WAIS-IV Digit-Symbol Coding, WAIS-IV Digit Span, WAIS-IV Letter-Number Sequencing, WMS-IV Logical Memory, CVLT-II). Raw scores from the neuropsychological test battery will be transformed to standardized T-scores (mean=50; SD=10) using published normative data. T-scores will be converted to a deficit score ranging from 0 (no impairment) to 5 (severe impairment) and averaged across all tests to calculate the GDS. A lower GDS score means better cognitive function.
Time frame: Baseline to 12 weeks
Change in cognitive function global deficit score (GDS) from baseline to 12 wks in patients on the multicomponent active arm compared to change in cognition from 12 wks to 24 wks in patients on the waitlist arm (following receiving cognitive training)
Change in cognitive function will be measured using cognitive function global deficit score (GDS) at baseline and 12 weeks on the multicomponent active arm and 12 weeks to 24 weeks on the waitlist arm following receiving the cognitive training only. The neuropsychological test battery will include the following tests: D-KEFS Verbal Fluency, DKEFS Color-Word Interference, D-KEFS Trail Making, WAIS-IV Digit-Symbol Coding, WAIS-IV Digit Span, WAIS-IV Letter-Number Sequencing, WMS-IV Logical Memory, CVLT-II). Raw scores from the neuropsychological test battery will be transformed to standardized T-scores (mean=50; SD=10) using published normative data. T-scores will be converted to a deficit score ranging from 0 (no impairment) to 5 (severe impairment) and averaged across all tests to calculate the GDS. A lower GDS score means better cognitive function.
Time frame: Baseline to 12 weeks for the multicomponent active arm and from 12 weeks to 24 weeks for the waitlist arm
Change in cognitive function global deficit score (GDS) from 12 wks to 24 wks in patients on the multicomponent active arm
Change in cognitive function will be measured using cognitive function global deficit score (GDS) at 12 weeks to 24 weeks on the multicomponent active arm. The neuropsychological test battery will include the following tests: D-KEFS Verbal Fluency, DKEFS Color-Word Interference, D-KEFS Trail Making, WAIS-IV Digit-Symbol Coding, WAIS-IV Digit Span, WAIS-IV Letter-Number Sequencing, WMS-IV Logical Memory, CVLT-II). Raw scores from the neuropsychological test battery will be transformed to standardized T-scores (mean=50; SD=10) using published normative data. T-scores will be converted to a deficit score ranging from 0 (no impairment) to 5 (severe impairment) and averaged across all tests to calculate the GDS. A lower GDS score means better cognitive function.
Time frame: 12 weeks to 24 weeks
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University of Alabama at Birmingham