DOI: 10.5061/dryad.kh18932d4
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

description: 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) &gt;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 were collected at baseline, three- and
 six-months.  Results: Capillary βHB indicated women
 achieved nutritional ketosis (Phase I mean: 0.8 mM (n = 15); Phase II
 mean: 0.7 mM (n = 9)). Body weight decreased 10% after three-months,
 primarily from body fat. Fasting plasma glucose, plasma insulin, and
 insulin resistance also decreased significantly after three-months (p
 &lt; 0.01), an effect that persisted at six-months. Conclusions: Women
 diagnosed with MBC undergoing chemotherapy can safely achieve and maintain
 nutritional ketosis, while improving body composition and insulin
 resistance, out to six-months.
description: 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 <em>p</em> &lt; 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).
description: # 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 PRISM to open and review/analyze the data ( ## DATA-SPECIFIC INFORMATION FOR: **KetoCARE\_PONE-D-23-27894\_Data.pzfx** Number of variables: 11 Number of participants: 20 Participant Naming Agreement: KC## (i.e., KetoCare Participant 1: KC01) Variable List: 1. Ketones (mM) 2. Glucose (mg/dL) 3. Glucose/Ketone Index (GKI) 4. Body Weight (kg) 5. Body Fat Percentage (%) 6. Body Fat Mass (kg) 7. Lean Body Mass (kg) 8. Plasma Insulin (uU/L) 9. Homeostatic Model of Insulin Resistance (HOMA-IR) 10. Gantt Chart (Timeline) 11. Individual Ketone Data (mM) - Raw Data 12. Clean Individual Ketone Data (mM) - Clean Data Sorted by Completers (6 months) and Partial (3 months) 13. Individual Glucose Data (mg/dL) - Raw Data 14. Clean Individual Glucose Data (mg/dL) - Clean Data Sorted by Completers (6 months) and Partial (3 months) 15. Unpaired T-Test of 3-month Ketones between Partial (Phase I) vs. Completers (Phase II) 16. Unpaired T-Test of 3-month Glucose between Partial (Phase I) vs. Completers (Phase II) Missing data: Yes 1. Cells that do not contain any values should be treated as "null." 2. Wherever data is complete, the PRISM algorithm assumed normal ANOVA statistics. 3. Wherever data was missing at random, the PRISM algorithm used a proprietary mixed-effects ANOVA model to preserve power, estimate the missing values, and obviate the need for case-wise deletion (i.e., remove the participant completely). Specialized formats or other abbreviations used: None ## DESCRIPTION OF THE DATA AND THE FILE STRUCTURE: 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* &lt; 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).