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. 2023 Oct 13;15(20):4357. doi: 10.3390/nu15204357

Table 1.

Clinical trials using the KD in breast cancer patients registered at https://clinicaltrials.gov (accessed on 20 July 2023).

ClinicalsTrials
Identifier
Status Objective of the Clinical Trial Intervention Disease
NCT05234502 O Impacts of KD on Overweight and Obese Women Diagnosed with Breast Cancer Alternative 1: Comprehensive and Well-Balanced Diet Regimen (Carbohydrates: 45–60%, Protein: 10–20%, Fat: 20–35%)
Alternative 2: Ketogenic Diet Regimen (Carbohydrates: 6%, Protein: 19%, Fat: 75%)
Breast Cancer Female
NCT03962647 O Two-Week Ketogenic Diet Coupled with Letrozole for the Regulation of PI3K Signaling in ER+ Breast Cancer Supplemental Diet: Two-Week Ketogenic Diet Regimen
Pharmaceutical Treatment: Letrozole
Estrogen Receptor-positive Breast Cancer
NCT03535701 C Exploring the Role of Ketogenic Diet and Chemotherapy in Modulating Recurrence in Stage IV Breast Cancer Patients Nutritional Addendum: Dietary Intervention Strategy
Alternate: Analysis of Lab-Based Biomarkers
Pharmaceutical: Administration of Paclitaxel
Stage IV Breast Cancer AJCC v6 and v7
NCT05090358 O Mitigating Hyperglycemia in Patients Undergoing Treatment for Metastatic Breast Cancer Nutritional Supplement: Implementation of the KD
Nutritional Supplement: Adoption of a Low-Carbohydrate Diet
Pharmaceutical: Usage of Alpelisib
Breast Cancer
Breast Cancer Stage IV
Metastatic Breast Cancer
NCT04469296 O Adjusting Nutritional Intake in Luminal Early Stage Breast Cancer Patients Candidate for Primary Surgery Nutritional Intervention 1: Iso-Caloric KD Regimen
Nutritional Intervention 2: Protein-Limited Dietary Approach
Breast Cancer
Surgery
NCT02092753 C Exploring Ketogenic or LOGI Dietary Approaches in Breast Cancer Recovery Intervention (KOLIBRI Study) Alternate Approach: Standard Dietary Plan (SD)
Experimental Approach 1: Ketogenic Dietary Regimen (KD)
Experimental Approach 2: Low Glycemic and Insulinemic Diet (LOGI)
Quality of Life
NCT02744079 C Comparative Study of Healthful Dietary Patterns on Biomarkers of Breast Cancer Behavioral Modification 1: Adoption of a Low-Carbohydrate Diet
Behavioral Modification 2: Implementation of a Low-Fat Diet
Breast Neoplasms

Abbreviations: C, closed; O, ongoing. A more detailed description of the studies reported in Table 1 is provided below to better elucidate the main results obtained by using the KD in patients with BC.