VLCKD: a real time safety study in obesity
Open accessAbstract
Background: Very Low-Calorie Ketogenic Diet (VLCKD) is currently a promising approach for the treatment of obesity. However, little is known about the side effects since most of the studies reporting them were carried out in normal weight subjects following Ketogenic Diet for other purposes than obesity. Thus, the aims of the study were: (1) to investigate the safety of VLCKD in subjects with obesity; (2) if VLCKD-related side effects could have an impact on its efficacy. Methods: In this prospective study we consecutively enrolled 106 subjects with obesity (12 males and 94 females, BMI 34.98 ± 5.43 kg/m 2) that underwent to VLCKD. In all subjects we recorded side effects at the end of ketogenic phase and assessed anthropometric parameters at the baseline and at the end of ketogenic phase. In a subgroup of 25 subjects, we also assessed biochemical parameters. Results: No serious side effects occurred in our population and those that did occur were clinically mild and did not lead to discontinuation of the dietary protocol as they could be easily managed by healthcare professionals or often resolved spontaneously. Nine (8.5%) subjects stopped VLCKD before the end of the protocol for the following reasons: 2 (1.9%) due to palatability and 7 (6.1%) due to excessive costs. Finally, there were no differences in terms of weight loss percentage (13.5 ± 10.9% vs 18.2 ± 8.9%; p = 0.318) in subjects that developed side effects and subjects that did not developed side effects. Conclusion: Our study demonstrated that VLCKD is a promising, safe and effective therapeutic tool for people with obesity. Despite common misgivings, side effects are mild, transient and can be prevented and managed by adhering to the appropriate indications and contraindications for VLCKD, following well-organized and standardized protocols and performing adequate clinical and laboratory monitoring.
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VLCKD has contraindications and side effects.
“The recommendation of VLCKD should be limited to specific patients and under supervision because of its contraindications and side effects (Tables 1 and 2) [13, 47, 48].”
From Ketogenic Diet as Medical Prescription in Women with Polycystic Ovary Syndrome (PCOS) (2023) · cites this paper as [48]
In a study of 106 individuals with obesity, VLCKD had mild side effects that could be avoided and controlled by adequately following the indications and contraindications for this diet.
“A recent study that included 106 individuals (12 males and 94 females) with obesity showed that VLCKD had mild side effects that could be avoided and controlled by adequately following the indications and contraindications for this diet [48].”
From Ketogenic Diet as Medical Prescription in Women with Polycystic Ovary Syndrome (PCOS) (2023) · cites this paper as [48]
Hip circumference dropped from 120.53 ± 10.81 cm to 115.91 ± 9.70 cm (p < 0.001).
“A significant drop in the waist and hip circumferences from 106.16 ± 14.20 cm to 99.24 ± 13.57 cm (p < 0.001) and 120.53 ± 10.81 cm to 115.91 ± 9.70 cm (p < 0.001), respectively, was also observed.”
From Ketogenic Diet as Medical Prescription in Women with Polycystic Ovary Syndrome (PCOS) (2023) · cites this paper as [48]
BMI reduced from 34.98 ± 5.43 kg/m2 to 32.35 ± 5.02 kg/m2 (p < 0.001).
“and BMI from 34.98 ± 5.43 kg/m2 to 32.35 ± 5.02 kg/m2 (p < 0.001).”
From Ketogenic Diet as Medical Prescription in Women with Polycystic Ovary Syndrome (PCOS) (2023) · cites this paper as [48]
In the study of 106 individuals with obesity, weight reduced from 94.38 ± 17.34 kg to 87.29 ± 15.99 kg (p < 0.001).
“The weight from baseline to the end of the ketogenic phase was reduced from 94.38 ± 17.34 kg to 87.29 ± 15.99 kg (p < 0.001)”
From Ketogenic Diet as Medical Prescription in Women with Polycystic Ovary Syndrome (PCOS) (2023) · cites this paper as [48]
Glucose decreased from 88.04 ± 8.95 mg/dL to 82.60 ± 10.08 mg/dL (p = 0.072), not statistically significant.
“Additionally, glucose decreased from 88.04 ± 8.95 mg/dL to 82.60 ± 10.08 mg/dL (p = 0.072), insulin from 17.35 mg/dL ± 13.83 mg/dL to 8.05 ± 5.48 mg/dL (p = 0.286), and HOMA-IR from 3.80 ± 2.79 to 1.74 ± 1.29 (p = 0.332) showing a slight improvement, but not statistically significant.”
From Ketogenic Diet as Medical Prescription in Women with Polycystic Ovary Syndrome (PCOS) (2023) · cites this paper as [48]
Insulin decreased from 17.35 ± 13.83 mg/dL to 8.05 ± 5.48 mg/dL (p = 0.286), not statistically significant.
“Additionally, glucose decreased from 88.04 ± 8.95 mg/dL to 82.60 ± 10.08 mg/dL (p = 0.072), insulin from 17.35 mg/dL ± 13.83 mg/dL to 8.05 ± 5.48 mg/dL (p = 0.286), and HOMA-IR from 3.80 ± 2.79 to 1.74 ± 1.29 (p = 0.332) showing a slight improvement, but not statistically significant.”
From Ketogenic Diet as Medical Prescription in Women with Polycystic Ovary Syndrome (PCOS) (2023) · cites this paper as [48]
Waist circumference dropped from 106.16 ± 14.20 cm to 99.24 ± 13.57 cm (p < 0.001).
“A significant drop in the waist and hip circumferences from 106.16 ± 14.20 cm to 99.24 ± 13.57 cm (p < 0.001) and 120.53 ± 10.81 cm to 115.91 ± 9.70 cm (p < 0.001), respectively, was also observed.”
From Ketogenic Diet as Medical Prescription in Women with Polycystic Ovary Syndrome (PCOS) (2023) · cites this paper as [48]
VLCKD is an effective and safe diet for patients with obesity.
“The study findings proved that VLCKD is an effective and safe diet for patients with obesity.”
From Ketogenic Diet as Medical Prescription in Women with Polycystic Ovary Syndrome (PCOS) (2023) · cites this paper as [48]
HOMA-IR decreased from 3.80 ± 2.79 to 1.74 ± 1.29 (p = 0.332), not statistically significant.
“Additionally, glucose decreased from 88.04 ± 8.95 mg/dL to 82.60 ± 10.08 mg/dL (p = 0.072), insulin from 17.35 mg/dL ± 13.83 mg/dL to 8.05 ± 5.48 mg/dL (p = 0.286), and HOMA-IR from 3.80 ± 2.79 to 1.74 ± 1.29 (p = 0.332) showing a slight improvement, but not statistically significant.”
From Ketogenic Diet as Medical Prescription in Women with Polycystic Ovary Syndrome (PCOS) (2023) · cites this paper as [48]
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СУЧАСНІ АСПЕКТИ ПРОФІЛАКТИКИ ОЖИРІННЯ
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- Authors
- Barrea, L., Verde, L., Vetrani, C., Marino, F., Aprano, S., Savastano, S., Colao, A., & Muscogiuri, G.
- Affiliations
- Federico II University Hospital (IT)
- Corresponding author
- Muscogiuri, Giovanna
- ORCID
- Venue
- Journal of Translational Medicine
- Published
- 2022-01-08
- Volume
- 20
- Issue
- 1
- Pages
- 23-23
- ISSN
- 1479-5876 (ISSN-L)
- PMC
- PMC8742928
- OpenAlex
- W4206838223
- Cited by
- 47
- References
- 51
- Citations by year
- 2026: 1 · 2025: 10 · 2024: 9 · 2023: 16 · 2022: 11
- FWCI
- 7.11
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Journal of Translational Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Physiology › Diet and metabolism studies
- Health Sciences › Medicine › Physiology › Dietary Effects on Health
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Keywords
- very low-calorie ketogenic diet, obesity, dietary safety, adverse effects, weight loss, palatability, cost barriers, dietary adherence, anthropometric parameters, biochemical parameters
- MeSH terms
- Anthropometry, Female, Humans, Male, Obesity, Prospective Studies, Weight Loss, Diet, Ketogenic
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