Feasibility of an MI-CBT ketogenic adherence program for older adults with mild cognitive impairment

Abstract

Background The National Institutes of Health Obesity-Related Behavioral Intervention Trials model for intervention development was used to establish the feasibility and proof of concept of a motivational ketogenic nutrition adherence program for older adults with mild cognitive impairment. Methods This was a single-arm, single-center feasibility trial. A comprehensive assessment protocol, including a clinical interview, neuropsychological testing, and genetic sequencing was used as an initial screening. Nine participants (aged 64–75) with possible amnestic mild cognitive impairment were consented for the intervention. Participants completed pre- and post-intervention neuropsychological assessments using the updated Repeatable Battery for Assessment of Neuropsychological Status. Participants tracked their macronutrient consumption using food diaries and ketone levels using urinalysis test strips daily. Mood and other psychosocial variables were collected through surveys, and qualitative exit interviews were completed. Results 100% of participants who began the trial completed the 6-week ketogenic nutrition adherence program, including completion of the pre- and post-assessments. Eight participants achieved measurable levels of ketones during the program. The average self-rated adherence across the program was 8.7 out of 10. A Wilcoxon Signed-Rank test demonstrated significant improvement in cognitive performance from baseline (median = 88) to follow up (median = 96, Z = − 2.26, p = .024). The average difference in cognitive performance from baseline to follow-up was − 7.33 (95% CI − 12.85, − 1.82). Conclusions Results supported the feasibility for moving to the next phase and demonstrated proof of concept for the intervention. The next step is a randomized pilot trial to test clinical signals of effect compared to a control condition. Trial registration This trial was retrospectively registered with clinicaltrials.gov on July 13, 2021. The trial number is NCT04968041.

Emerging Nutrition Approaches to Support the Mind and Muscle for Healthy Aging

“…Another small trial showed the ketogenic diet improved a cognitive component of the Alzheimer’s disease Assessment scale over a 12-week intervention [ 37 ]. Finally, yet another small trial conducted by Sheffler et al included 9 older adults who were counseled to consume a ketogenic diet for 6 weeks, after which they observed significant improvement in cognitive performance [ 38 ]. Taken together, these small clinical trials support the ketogenic diet as a potential therapeutic strategy for mild cognitive impairment with aging.…”

Improving Adherence to a Mediterranean Ketogenic Nutrition Program for High-Risk Older Adults: A Pilot Randomized Trial

“…Further, ORBIT provides a pathway for refining and tailoring interventions to address community needs and improve scaling and dissemination of effective interventions. Using the ORBIT model, our team established the proof-of-concept for a community-focused MKN program that uses motivational interviewing strategies and behavior change techniques (MI-BCT) to enhance adherence [ 17 ].…”

“…BCTs are often considered the ‘active ingredient’ in behavioral interventions that influence mechanisms of action [ 18 ]. Our team used the NIH ORBIT framework for developing behavioral interventions to address chronic conditions [ 16 ] and has previously established the proof-of-concept for this MKN adherence (MKNA) program [ 17 ].…”