Trial reportLipids in health and disease2016
Effects of sardine-enriched diet on metabolic control, inflammation and gut microbiota in drug-naïve patients with type 2 diabetes: a pilot randomized trial.
Trial report in Lipids in health and disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02294526 (PILCHARDUS STUDY), which is not on this map. Cited by 73 papers, 9 of them syntheses that pooled it.
What it found
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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.
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.
PILCHARDUS STUDY: A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients
Who cites it
73 citing papers in PubMed, 9 syntheses or guidelines pooled it, 139 citations in OpenAlex.
- Gut microbiome-based interventions for the management of obesity in children and adolescents aged up to 19 years.The Cochrane database of systematic reviews · 2025Pooled it
- Gut microbiota bridges dietary nutrients and host immunity.Science China. Life sciences · 2023Pooled it
- The Potential Cardiometabolic Effects of Long-Chain ω-3 Polyunsaturated Fatty Acids: Recent Updates and Controversies.Advances in nutrition (Bethesda, Md.) · 2023Pooled it
- Meat Consumption and Gut Microbiota: a Scoping Review of Literature and Systematic Review of Randomized Controlled Trials in Adults.Advances in nutrition (Bethesda, Md.) · 2023Pooled it
- Dietary intervention improves metabolic levels in patients with type 2 diabetes through the gut microbiota: a systematic review and meta-analysis.Frontiers in nutrition · 2023Pooled it
- Microbiome Changes after Type 2 Diabetes Treatment: A Systematic Review.Medicina (Kaunas, Lithuania) · 2021Pooled it
- Long-term effects of increasing omega-3, omega-6 and total polyunsaturated fats on inflammatory bowel disease and markers of inflammation: a systematic review and meta-analysis of randomized controlled trials.European journal of nutrition · 2021Pooled it
- Systematic review assessing the effectiveness of dietary intervention on gut microbiota in adults with type 2 diabetes.Diabetologia · 2018Pooled it
- Systematic Review of the Effect of Enteral Feeding on Gut Microbiota in Preterm Infants.Journal of obstetric, gynecologic, and neonatal nursing : JOGNN · 2018Pooled it
- Gut microbial community and host intestinal gene expression with combined fish oil and soluble corn fiber compared with corn oil and maltodextrin: A randomized crossover trial in healthy older individuals.The American journal of clinical nutrition · 2025Trial
- Omega-3 nanoemulgel in prevention of radiation-induced oral mucositis and its associated effect on microbiome: a randomized clinical trial.BMC oral health · 2023Trial
- The prebiotic effects of omega-3 fatty acid supplementation: A six-week randomised intervention trial.Gut microbesTrial
- Gut Microbiome-Associated Effects of Plant-Based Diets on Glucose Homeostasis, Body Composition, and Cognitive Function: A Scoping Review.Advances in nutrition (Bethesda, Md.) · 2026Article
- Microbiota and lipid mediators: from molecular crosstalk to therapeutic opportunities.Frontiers in pharmacology · 2026Review
- Preventing effect of plant extracts and omega-3 on age-related cognitive decline in male mice.Brain, behavior, & immunity - health · 2025Article
- The gut immune axis in ulcerative colitis: insights from microbiome research.Molecular biology reports · 2025Review
- Potential and Future Therapeutic Applications of Eicosapentaenoic/Docosahexaenoic Acid and Probiotics in Chronic Low-Grade Inflammation.Biomedicines · 2025Review
- Review
- Effect of Fatty Acids on Glucose Metabolism and Type 2 Diabetes.Nutrition reviews · 2025Review
- Comparative assessment of phenotypic markers in patients with chronic inflammation: Differences on Bifidobacterium concerning liver status.European journal of clinical investigation · 2025Article
13 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 9 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNutrition therapy is the cornerstone of treating diabetes mellitus. The inclusion of fish (particularly oily fish) at least two times per week is recommended by current international dietary guidelines for type 2 diabetes. In contrast to a large number of human studies examining the effects of oily fish on different cardiovascular risk factors, little research on this topic is available in patients with type 2 diabetes. The aims of this pilot study were to investigate the effects of a sardine-enriched diet on metabolic control, adiponectin, inflammatory markers, erythrocyte membrane fatty acid (EMFA) composition, and gut microbiota in drug-naïve patients with type 2 diabetes.
methods35 drug-naïve patients with type 2 diabetes were randomized to follow either a type 2 diabetes standard diet (control group: CG), or a standard diet enriched with 100 g of sardines 5 days a week (sardine group: SG) for 6 months. Anthropometric, dietary information, fasting glycated hemoglobin, glucose, insulin, adiponectin, inflammatory markers, EMFA and specific bacterial strains were determined before and after intervention.
resultsThere were no significant differences in glycemic control between groups at the end of the study. Both groups decreased plasma insulin (SG: -35.3%, P = 0.01, CG: -22.6%, P = 0.02) and homeostasis model of assessment--insulin resistance (HOMA-IR) (SG: -39.2%, P = 0.007, CG: -21.8%, P = 0.04) at 6-months from baseline. However only SG increased adiponectin in plasma compared to baseline level (+40.7%, P = 0.04). The omega-3 index increased 2.6% in the SG compared to 0.6% in the CG (P = 0.001). Both dietary interventions decreased phylum Firmicutes (SG and CG: P = 0.04) and increased E. coli concentrations (SG: P = 0.01, CG: P = 0.03) at the end of the study from baseline, whereas SG decreased Firmicutes/Bacteroidetes ratio (P = 0.04) and increased Bacteroides-Prevotella (P = 0.004) compared to baseline.
conclusionsAlthough enriching diet with 100 g of sardines 5 days a week during 6 months to a type 2 diabetes standard diet seems to have neutral effects on glycemic control in drug-naïve patients with type 2 diabetes, this nutritional intervention could have beneficial effects on cardiovascular risk. Furthermore, both dietary interventions decreased HOMA-IR and altered gut microbiota composition of drug-naïve patients with type 2 diabetes.
trial registrationTrial number and name of the registry: NCT02294526, ClinicalTrials.gov.
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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.