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
Data files
Jan 04, 2024 version files 1.26 MB
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KetoCARE_PONE-D-23-27894_Data.pzfx
1.25 MB
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README.md
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Abstract
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 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 < 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.
README: 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: volek.1@osu.edu
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: buga.1@osu.edu
Date of Data Collection:
2016 - 2019
Geographic Location of Data Collection:
Columbus, OH USA.
Funding Sources:
Lotte and John Hecht Foundation for Cancer Research (https://www.hecht.org/).
Relevant Links:
Dryad Repository Link: https://doi.org/10.5061/dryad.kh18932d4
Full Publication Link: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0296523
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 (https://www.graphpad.com/features)
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:
- Ketones (mM)
- Glucose (mg/dL)
- Glucose/Ketone Index (GKI)
- Body Weight (kg)
- Body Fat Percentage (%)
- Body Fat Mass (kg)
- Lean Body Mass (kg)
- Plasma Insulin (uU/L)
- Homeostatic Model of Insulin Resistance (HOMA-IR)
- Gantt Chart (Timeline)
- Individual Ketone Data (mM) - Raw Data
- Clean Individual Ketone Data (mM) - Clean Data Sorted by Completers (6 months) and Partial (3 months)
- Individual Glucose Data (mg/dL) - Raw Data
- Clean Individual Glucose Data (mg/dL) - Clean Data Sorted by Completers (6 months) and Partial (3 months)
- Unpaired T-Test of 3-month Ketones between Partial (Phase I) vs. Completers (Phase II)
- Unpaired T-Test of 3-month Glucose between Partial (Phase I) vs. Completers (Phase II)
Missing data: Yes
- Cells that do not contain any values should be treated as "null."
- Wherever data is complete, the PRISM algorithm assumed normal ANOVA statistics.
- 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 < 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).
Methods
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).