Ketogenicdiet versus standard high-carbohydrate nutrition in sepsis: a randomized controlled trial
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ABSTRACT:
PROVIDER: PRJNA1005592 | ENA |
REPOSITORIES: ENA
Dataset's files
| Action | DRS | |||
|---|---|---|---|---|
| SRR25646400_1.fastq.gz | Fastqsanger.gz | |||
| SRR25646400_2.fastq.gz | Fastqsanger.gz | |||
| SRR25646401_1.fastq.gz | Fastqsanger.gz | |||
| SRR25646401_2.fastq.gz | Fastqsanger.gz | |||
| SRR25646402_1.fastq.gz | Fastqsanger.gz |
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Project description:Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard nutritional approaches relying primarily on carbohydrates. We here hypothesize that a ketogenic diet improves sepsis treatment. We conducted a monocentric open-labeled randomized controlled trial enrolling 40 adult sepsis patients. Patients were randomly assigned to either ketogenic diet (KD) or standard high-carbohydrate nutrition for 14 days and followed up until day 30. The primary outcome measure was β-hydroxybutyrate (BHB) serum concentration on day 14. We assessed feasibility and safety of KD, as well as diet-associated clinical and immunological changes. The respective nutrition protocols were successfully applied, dropouts did not occur. Regression analysis revealed a greater increase in BHB concentrations from baseline to day 14 in KD patients compared to controls. Metabolic side effects were not observed under ketogenic diet. Ventilation-free, vasopressor-free, dialysis-free and ICU-free days significantly increased in patients under ketogenic diet. Transcriptome profiling of both CD4+ and CD8+ T cells at day 14 revealed substantial differential regulation of gene expression in the KD vs. the control group indicating a reduced T-cell activation and a shift towards a more regulated immunity.
2024-06-13 | GSE240861 | GEO
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:Adults who survive intensive care unit (ICU) admission with sepsis (referred to as sepsis survivors) have immune impairments that increase their long-term risk of reinfections and mortality. Although vaccinations may reverse immune impairments, vaccine immunogenicity has never been examined in sepsis survivors. Here, in a 1:1 randomized placebo-controlled trial, we tested the efficacy and immunogenicity of a single intramuscular dose of 13-valent pneumococcal conjugate vaccine (PCV13) in 214 sepsis survivors. The primary outcome was time to first infection-related rehospitalization or death during 365 days of follow-up. PCV13 immunogenicity assessments included serotype-specific immunoglobulin-G (IgG) concentrations, immunophenotyping and panleukocyte transcriptome, measured at baseline(T0), 10(±3)days(T1), and 30(±7)days(T2) post-randomization. The PCV13 group (n=104) had 43 primary outcome events among 72.5 person-years of follow-up compared with 38 events among 76.5 person-years of follow-up in the placebo group (n=110) [hazard ratio 1.23 (95%CI,0.80-1.91)]. There were no vaccine-related serious adverse events. PCV13 induced serotype-specific IgG responses, exhibiting variations across serotypes and participants. Additionally, there were changes in blood transcriptional modules and pre-vaccination inflammatory endotypes that explain this variation in IgG responses. Of note, clinical outcomes were better albeit not statistically significant, in participants with ≥2-fold increase in ≥2 serotype-specific IgG. Better understanding of variations in vaccine immunogenicity in sepsis survivors is crucial for improving long-term outcomes. '(ClinicalTrials.gov identifier NCT03565159).
2026-08-31 | GSE317767 | GEO
Project description:Objective To explore the effects of three diets differing in amount and type of refined carbohydrates on peripheral immunity. Methods After a weight loss of 15% with a very low carbohydrate diet (VLCD), participants were randomized to isocaloric diets: VLCD diet; high carbohydrate diet with high starch content (HC-Starch); or high carbohydrate diet with high sugar content (HC-Sugar). Changes in peripheral immunity were assessed using a multimodal analyses before randomization and after 10 weeks of diet. Results Multiplexed cytokine analysis shows increased adipsin in HC-Starch and decreased adiponectin in HC-Sugar. Transcriptomics analysis shows upregulation of immune and metabolic pathways with HC-Starch, but reductions with HC-Sugar. CyTOF revealed significant shifts in NK cell populations and increased inflammatory markers in neutrophils and monocytes following consumption of HC-Starch. Conclusions Consumption of refined starch following weight loss on a VLCD increases circulating markers of immune activity, whereas sugar consumption reduces these markers. Keywords: dietary nutrients, immunity, refined starch, added sugar, VLCD, cytokines, gene expression, CyTOF, inflammation, immune cells. ClinicalTrials.gov registration: NCT03394664
2026-07-27 | GSE278745 | GEO
Project description:Reduced protein intake is associated with adverse outcomes in critically ill patients. Paradoxically, large scale randomized clinical trials have failed to demonstrate a beneficial effect of protein supplementation, perhaps because biological mechanisms associated with individual patient responses to nutrition, are poorly understood. The objective of this study was to determine the effect of exogenous protein dose on whole body protein balance (WBPB) and associated blood transcriptomic markers of metabolic response.
2025-06-05 | GSE298552 | GEO
Project description:To evaluate whether clarithromycin improves 28-day mortality among patients with sepsis, respiratory and multiple-organ dysfunction syndrome. The INntravenous CLArithromycin in Sepsis and multiple organ dysfunction Syndrome trial was a phase 3, randomized, double blind, placebo-controlled clinical study, conducted in 11 intensive care units and 2 Internal Medicine wards in 2 countries. Patients with sepsis, respiratory failure and total sequential organ failure assessment score of ≥7 were enrolled between December 2017 and September 2019. Follow-up lasted 90 days. Patients were randomized to receive 1 gr of intravenous clarithromycin or placebo once daily for 4 consecutive days.
2022-06-30 | GSE196117 | GEO
Project description:Objectives: To evaluate the feasibility of a very low carbohydrate, ketogenic, diet in women with endometrial cancer and obesity, and to assess the effects of this dietary pattern on metabolism and tumor biology. Design: A multicentre, parallel, prospective, randomized, controlled feasibility study in treatment naïve women with endometrial cancer. Participants were randomized in a 2:1 fashion to a very-low carbohydrate (VLCD) diet, or to continue with their standard diet (SD) by the method of random permuted block. Setting: Eight locations from two teaching hospitals in the New York and New Jersey areas. Participants: 19 treatment naïve women with endometrial cancer (stages IA-IIIC2) and obesity. 15 completed the study. Intervention: After initial biopsy and pathology confirmation, participants received 21-28 days of VLCD and weekly nutritional counseling, followed by surgical staging. Main outcome measures: Dietary adherence, rates of attrition, and adverse effects. Changes in circulating concentration of metabolic biomarkers. Changes in immunohistochemical staining and RNA-Sequencing for insulin signaling pathway, cell apoptosis, proliferation, and immunity. Results: Of the 19 participants randomized, 15 finished the trial with an overall attrition rate of 21%. Participants in the VLCD arm reported consuming 91 ± 4% of the meals, leading to a rise in ketone bodies for all participants by day 3 or 4 and an overall weight loss of 5.5 ± 0.8%. The VLCD was well-tolerated with no grade 3/4 adverse events. Fasting plasma glucose and insulin levels were reduced by 22 ± 5.9% and 60 ± 3.8%, respectively. Total cholesterol and low-density lipoprotein (LDL) were increased by 6 ± 2.7% and 17.8 ± 8.9%, respectively. Gene Set Enrichment Analysis using RNA-Seq revealed enrichment in pathways related to fatty acid oxidation, oxidative phosphorylation, estrogen response, interferon-alpha response and CD8+ T cells (p < 0.05 and NES > 1.60). CD8+ T cells were found to infiltrate the tumor margins under VLCD compared to SD (p = 0.019). Conclusions: A VLCD is feasible and well-tolerated in obese and overweight women with endometrial cancer and leads to significant host and tumor metabolic changes that suggest potential therapeutic benefits that warrant further investigation in larger clinical trials.
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