Evidence map›Paper›PMID 25986079›Full record

Observational studyHigh blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension2015

Middle and Long-Term Impact of a Very Low-Carbohydrate Ketogenic Diet on Cardiometabolic Factors: A Multi-Center, Cross-Sectional, Clinical Study.

Arrigo F G Cicero, Maddalena Benelli, Marco Brancaleoni, Giuseppe Dainelli, Desiré Merlini, Raffaele Negri

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05275608 (Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation), which is not on this map. Cited by 51 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 4 pooled it
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05275608 narecruitingnot on this mapstarted 2022, after this paper: background citation

Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation: Pilot Study on Patients with Metabolic Syndrome

TypeinterventionalSponsorAzienda Ospedaliero Universitaria Maggiore della CaritaRan2022 to 2025Enrolled40ConditionsDiabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity, Metabolic SyndromeArmsVLCKD diet with replacing meals, Hypocaloric mediterranean Diet
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 4 syntheses or guidelines pooled it, 133 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Trial
  6. Trial
  7. RESET-PKD: a pilot trial on short-term ketogenic interventions in autosomal dominant polycystic kidney disease.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023
    Trial
  8. Heart Rate Variability and Sympathetic Activity Is Modulated by Very Low-Calorie Ketogenic Diet.International journal of environmental research and public health · 2022
    Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Article
  14. Ketogenic diet, cardiometabolic diseases and aging.Journal of geriatric cardiology : JGC · 2026
    Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Arrigo F G CiceroMedical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, University of Bologna, U.O. Medicina Interna Borghi-Via Albertoni, 15, Bologna, Italy. afgcicero@cardionet.it.
Maddalena BenelliSanta Chiara Foundation, Lodi, Italy.
Marco BrancaleoniNational Public Health System, Rome, Italy.
Giuseppe DainelliNational Public Health System, Rome, Italy.
Desiré MerliniNational Public Health System, Rome, Italy.
Raffaele NegriNational Public Health System, Rome, Italy.
IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionObesity is a constantly growing illness in developed countries and it is strictly related to cardiovascular (CV) diseases, i.e. the main cause of mortality throughout industralised areas.

aimto test the ability of trained general physician to safely and effectively prescribe a very-low carbohydrate ketogenic (VLCK) diet in clinical practice, with a specific attention to the effect of this approach on overweight related CV risk factors (anthropometric measures) blood pressure, lipid levels, glucose metabolism).

methodsThe study has been carried out on a group of 377 patients scattered across Italy and monitored during 1 year. The proposed VLCK diet is a nutritional regimen characterized by low-fat and low- carbohydrates formulations and a protein content of 1.2/1.5 g/kg of ideal body weight, followed by a period of slow re-insertion and alimentary re-education.

resultsAll the predetermined goals-namely safety, reduction of body weight and CV risk factors levels-have been reached with a significant reduction of body weight (from baseline to 4 weeks (-7 ± 5 kg, p < 0.001), from 4 to 12 weeks (-5 ± 3 kg, p < 0.001), no changes from 12 weeks to 12 months; waistline (from baseline to 4 weeks (-7 ± 4 cm, p < 0.001), from 4 to 12 weeks (-5 ± 7 cm, p < 0.001), no changes from 12 weeks to 12 months; fatty mass (from baseline to 4 weeks (-3.8 ± 3.8 %, p < 0.001), from 4 to 12 weeks (-3.4 ± 3.5 %, p < 0.001), no changes from 12 weeks to 12 months; SBP from baseline to 3 months (-10.5 ± 6.4 mmHg, p < 0.001), no further changes after 1 year of observation).

conclusionthe tested VLCD diet suggested by trained general physicians in the setting of clinical practice seems to be able to significantly improve on the middle-term a number of anthropometric, haemodynamic and laboratory with an overall good tolerability.

Indexed as

Diet, Carbohydrate-RestrictedDiet, KetogenicAdiposityAdultBiomarkersBlood GlucoseBlood PressureCross-Sectional StudiesDietary ProteinsDiet, Fat-RestrictedFemaleGeneral PracticeHumansItalyLipidsMaleBiomarkersBlood GlucoseDietary ProteinsLipidsCardiovascular risk factorsGeneral practiceKetogenic dietSafety

Identifiers

PMID25986079
PMCPMC4666896
OpenAlexW1525155313

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.