NCT04968041

KNA Proof-of-Concept

Completed NA Results posted Last updated 1 March 2024

What this trial tests

NA trial testing Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program in Adherence, Treatment in 10 participants. Completed in 30 August 2020.

Timeline

27 September 2019

Primary endpoint
30 June 2020

30 August 2020

Quick facts

Lead sponsor	Florida State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	10
Start date	27 September 2019
Primary completion	30 June 2020
Estimated completion	30 August 2020
Sites	1 location across United States

Drugs / interventions tested

• Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program

Conditions studied

• Adherence, Treatment — all drugs for Adherence, Treatment →
• Retention — all drugs for Retention →
• Cognitive Impairment, Mild — all drugs for Cognitive Impairment, Mild →

Sponsor

Florida State University

Who can join

Adults 60 to 75, any sex, with Adherence, Treatment or Retention. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ketogenic Adherence Primary · 6-weeks

Assessed based on reported ketone levels during the program (reporting at least one day or greater with trace amounts of ketones) using urinalysis ketone test strips administered at home by participants.

Group	Value	95% CI
MI-CBT KNA Program	8

Acceptability Primary · 6-weeks

Assessed based on qualitative feedback and online surveys described here: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-022-00970-z. Participants also rated how well they felt the program helped them achieve their health-related goals 0 (none) to 3 (all).

All goals

Group	Value	95% CI
MI-CBT KNA Program	3

Most

Group	Value	95% CI
MI-CBT KNA Program	1

Some

Group	Value	95% CI
MI-CBT KNA Program	5

Retention Primary · baseline to 6-weeks

Assessed based on attendance and % of participants who remained in the program from start to finish

Group	Value	95% CI
MI-CBT KNA Program	9

Cognitive Functioning Secondary · Baseline and 6-weeks

Assessed using the total scaled score (age-normed) of the Repeatable Battery for the Assessment of Neuropsychological Status - Update. A score of 100 is considered "average" (50th percentile), and higher scores are considered better cognitive functioning. The outcome reported is the actual value at 6-weeks, rather than a change score.

Group	Value	95% CI
MI-CBT KNA Program	97.11	± 11.14

Sponsor's own description

The intervention program proof-of-concept was assessed as a single-arm, within-subjects clinical study with a target enrollment of 10 participants with possible or probable amnestic MCI. The protocol required participants to complete a pre-intervention assessment within two weeks of beginning the intervention, attend seven, one-hour intervention group sessions across six weeks, complete a post-assessment and interview in the final week of the intervention, and complete weekly surveys throughout the intervention.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ketone Supplementation: Meeting the Needs of the Brain in an Energy Crisis.
   Poff AM, Moss S, Soliven M, D'Agostino DP. · · 2021 · cited 34× · PMID 35004814 · DOI 10.3389/fnut.2021.783659
2. Feasibility of an MI-CBT ketogenic adherence program for older adults with mild cognitive impairment.
   Sheffler JL, Arjmandi B, Quinn J, Hajcak G, et al · · 2022 · cited 5× · PMID 35065656 · DOI 10.1186/s40814-022-00970-z