Ketogenic diet as a therapeutic intervention for biochemical hyperandrogenism in PCOS women with obesity or overweight: a meta-analytic study
6 affiliations
- 1Andrology and Gender Endocrinology Unit, Careggi University Hospital, Florence, Italy
- 2Department of Experimental and Clinical Biomedical Sciences “Mario Serio”, University of Florence, Florence, Italy
- 3Second Department of Obstetrics and Gynecology, School of Medicine, Aretaieion University Hospital, National and Kapodistrian University of Athens, Athens, Greece
- 4Forensic Medical Sciences, Department of Health Science, University of Florence, Florence, Italy
- 5Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy
- 6I.N.B.B. (Istituto Nazionale Biostrutture E Biosistemi), Rome, Italy
Abstract
Purpose: To assess whether the Ketogenic Diet (KD) is associated with improvements in biochemical markers of hyperandrogenism in women diagnosed with Polycystic Ovary Syndrome (PCOS) with obesity or overweight.
Methods: A systematic search was conducted in five databases: MEDLINE (via PubMed), Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, and Web of Science. Both RCTs and pre-post studies providing data for direct extraction or calculation of mean (SD) changes in the investigated outcomes, published until March 1, 2025, were considered. Protocols included “Very Low” and “Low” Calories KD, and modified KD regimens. The primary outcome was the effect of the KD on total testosterone (TT), Free T (FT) and Sex Hormone Binding Globulin (SHBG) compared to baseline.
Results: The KD was found to be associated with a statistically significant reduction in TT (n = 290, Mean Difference [MD] -0.35, CI -0.46; -0.24) and a significant increase in SHBG levels (n = 144, MD 19.50, CI 6.90; 32.11), independently of study design. When considering only RCTs (4 studies), the KD showed a moderate, statistically significant benefit on TT levels compared to the control intervention, with a high heterogeneity (n = 115 vs. 117, SMD -0.284, CI -0.543, -0.035; p = 0.031). Neither the duration of the KD protocol, the change in BMI, the change in fasting insulin levels nor the change in LH/FSH ratio were able to significantly affect the change in TT levels observed over time. In addition, the KD associated with a significant reduction in LH levels (n = 275, MD -3.48, CI -4.71; -2.26) and in the LH/FSH ratio (n = 275, MD -0.99, CI -1.44; -0.54).
Conclusion: Our meta-analysis indicates a reduced biochemical hyperandrogenism—particularly a reduction in TT—and a reduction in the LH/FSH ratio among women with PCOS following a KD. Our findings also suggest a specific effect of ketosis on ovarian function acting alongside metabolic improvements, but a direct causal link cannot be definitively established. Owing to the low quality and heterogeneous nature of the available studies, larger, high-quality RCTs are essential to consolidate this evidence and determine clinical efficacy.
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s40618-026-02924-1.
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BibTeX
@article{maseroli2026ketogenic,
title = {{Ketogenic diet as a therapeutic intervention for biochemical hyperandrogenism in PCOS women with obesity or overweight: a meta-analytic study}},
author = {Elisa Maseroli and Chiara Alfaroli and Michela Cirillo and Serena Anna Ravelli and Irene Lambrinoudaki and Martina Focardi and Gianni Virgili and Linda Vignozzi},
journal = {Journal of Endocrinological Investigation},
year = {2026},
month = jun,
doi = {10.1007/s40618-026-02924-1},
url = {https://doi.org/10.1007/s40618-026-02924-1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Ketogenic diet as a therapeutic intervention for biochemical hyperandrogenism in PCOS women with obesity or overweight: a meta-analytic study
AU - Elisa Maseroli
AU - Chiara Alfaroli
AU - Michela Cirillo
AU - Serena Anna Ravelli
AU - Irene Lambrinoudaki
AU - Martina Focardi
AU - Gianni Virgili
AU - Linda Vignozzi
PY - 2026
DA - 2026/06/13
JO - Journal of Endocrinological Investigation
DO - 10.1007/s40618-026-02924-1
UR - https://doi.org/10.1007/s40618-026-02924-1
AB - Purpose: To assess whether the Ketogenic Diet (KD) is associated with improvements in biochemical markers of hyperandrogenism in women diagnosed with Polycystic Ovary Syndrome (PCOS) with obesity or overweight. Methods: A systematic search was conducted in five databases: MEDLINE (via PubMed), Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, and Web of Science. Both RCTs and pre-post studies providing data for direct extraction or calculation of mean (SD) changes in the investigated outcomes, published until March 1, 2025, were considered. Protocols included “Very Low” and “Low” Calories KD, and modified KD regimens. The primary outcome was the effect of the KD on total testosterone (TT), Free T (FT) and Sex Hormone Binding Globulin (SHBG) compared to baseline. Results: The KD was found to be associated with a statistically significant reduction in TT (n = 290, Mean Difference [MD] -0.35, CI -0.46; -0.24) and a significant increase in SHBG levels (n = 144, MD 19.50, CI 6.90; 32.11), independently of study design. When considering only RCTs (4 studies), the KD showed a moderate, statistically significant benefit on TT levels compared to the control intervention, with a high heterogeneity (n = 115 vs. 117, SMD -0.284, CI -0.543, -0.035; p = 0.031). Neither the duration of the KD protocol, the change in BMI, the change in fasting insulin levels nor the change in LH/FSH ratio were able to significantly affect the change in TT levels observed over time. In addition, the KD associated with a significant reduction in LH levels (n = 275, MD -3.48, CI -4.71; -2.26) and in the LH/FSH ratio (n = 275, MD -0.99, CI -1.44; -0.54). Conclusion: Our meta-analysis indicates a reduced biochemical hyperandrogenism—particularly a reduction in TT—and a reduction in the LH/FSH ratio among women with PCOS following a KD. Our findings also suggest a specific effect of ketosis on ovarian function acting alongside metabolic improvements, but a direct causal link cannot be definitively established. Owing to the low quality and heterogeneous nature of the available studies, larger, high-quality RCTs are essential to consolidate this evidence and determine clinical efficacy. Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s40618-026-02924-1.
SN - 0391-4097
SN - 1720-8386
ER -