Feasibility and metabolic outcomes of a well-formulated ketogenic diet as an adjuvant therapeutic intervention for women with stage IV metastatic breast cancer: The Keto-CARE trial

Purpose:
Ketogenic diets may positively influence cancer through pleiotropic mechanisms, but only a few small and short-term studies have addressed feasibility and efficacy in cancer patients. The primary goals of this study were to evaluate the feasibility and the sustained metabolic effects of a personalized well-formulated ketogenic diet (WFKD) designed to achieve consistent blood beta-hydroxybutyrate (βHB) >0.5 mM in women diagnosed with stage IV metastatic breast cancer (MBC) undergoing chemotherapy.
Methods: 
Women (n = 20) were enrolled in a six-month two-phase, single-arm WFKD intervention (NCT03535701). Phase I was a highly-supervised, ad libitum, personalized WFKD, where women were provided with ketogenic-appropriate food daily for three-months. Phase II transitioned women to a self-administered WFKD with ongoing coaching for an additional three-months. Fasting capillary βHB and glucose were collected daily; weight, body composition, plasma insulin, and insulin resistance w..., Analyses and graphs were performed using GraphPad Prism (ver. 9.1.0, GraphPad Software, San Diego, California USA). Two-tail α significance was set at p < 0.05. All the variables of interest were screened for normality and homogeneity of variance using the Shapiro-Wilk test and Mauchly’s sphericity test, respectively. Violations of sphericity were treated with the Greenhouse-Geisser adjustment. For Phase I endpoints, we analyzed the main effects of time using paired samples t-tests (BL vs. 3 MO). When including Phase II endpoints, we used a 1 (condition) x 3 (time) repeated-measures mixed-effects analysis of variance (RM ANOVA) with Bonferroni post-hoc corrections to analyze the differences between BL and 3 MO; BL and 6 MO; and 3 MO and 6 MO. We additionally compared weekly fasting glucose/βHB mean concentrations and variability between phases using an unpaired t-test (Phase I vs. Phase II)., , # Title: Feasibility and Metabolic Outcomes of a Well-Formulated Ketogenic Diet as an Adjuvant Therapeutic Intervention for Women with Stage IV Metastatic Breast Cancer: The Keto-CARE Trial

## GENERAL INFORMATION:

#### Contact:

Principal Investigator Contact Information:

* Name: Jeff S. Volek
* Institution: The Ohio State University
* Address: PAES Building, 305 Annie and John Glenn Avenue, Columbus OH, 43210
* Email:

Lead Author Contact Information:

* Name: Alex Buga
* Institution: The Ohio State University
* Address: PAES Building, 305 Annie and John Glenn Avenue, Columbus OH, 43210
* Email:

#### Date of Data Collection:

2016 - 2019

#### Geographic Location of Data Collection:

Columbus, OH USA.

#### Funding Sources:

Lotte and John Hecht Foundation for Cancer Research (

#### Relevant Links:

Dryad Repository Link:

Full Publication Link:

## DATA FILE OVERVIEW:

1 x PRISM ver. 9 data file: KetoCARE_PONE-D-23-27894_Data.pzfx

This file requires GraphPad ...