Table 1.
Clinical Trials Addressing Nutrigenomic Interventions in NAFLD Patients.
| Clinical Trial Start-End Date |
Status | Study Type | Interventions | Conditions | Objectives | Locations |
|---|---|---|---|---|---|---|
|
NCT00760513 11/09-11/18 |
Completed (n = 103) |
Interventional Randomized Phase IV |
Omega-3-acid (OMACOR) 4 gr/d oral capsule for 18 months versus placebo | Biopsy-verified NASH or Ultrasound-verified NAFLD | Identify the effects of n-3 fatty acids on fibrosis and cardiovascular risk biomarkers in NAFLD patients | Southampton General Hospital Southampton, Hants, United Kingdom |
|
NCT00885313 03/09–03/11 |
Completed (n = 60) |
Interventional Randomized Phase II |
DHA 250 or 500mg/kg/d oral for 24 months vs. placebo | NAFLD and obesity in children | Evaluate the effects of DHA on Children With NAFLD | Bambino Gesù Hospital and Research Institute Rome, Italy |
|
NCT00697580 05/059–06/07 |
Completed (n = 104) |
Interventional Randomized |
Behavioral: Nutrition changes and physical exercise | NAFLD and obesity in adolescents | Investigate the Intra-Abdominal Fat, insulin sensitivity and Risk of Disease in Adolescents | Veronica Atkins Lifestyle Intervention Laboratory Los Angeles, CA (USA) |
|
NCT00072995 09/03–09/07 |
Completed (n = 811) |
Interventional |
Four Diets Differing in Macronutrient Composition and Low in Saturated Fat | Cardiovascular disease, NAFLD, obesity | Preventing Obesity Using Novel Dietary Strategies | Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA (USA). Harvard University School of Public Health, Boston, MA (USA) |
|
NCT01530139 02/12–02/16 |
Completed (n = 1607) |
Interventional Randomized |
Three personalized diets (Food4Me) versus control diet | Adult individuals | Personalization of dietary advices based on biochemical and/or genetic information | Universities of Newcastle; College Dublin; Maastricht; Oslo; Navarra; Harokopio; Reading; München; Newcastle Upon-Tyne and National Food and Nutrition Institute |
|
NCT02663388 01/16–12/19 |
Recruiting (n = 20,000) * |
Observational | Gastric bypass, sleeve, gastric banding | Cardiovascular disease, NAFLD, obesity, MetS, T2D | Evaluate DNA Methylation on severe obesity-related complications before and after bariatric surgery | University of Lorraine, CHU Nancy Vandoeuvre Les Nancy, France |
|
NCT03183193 06/16–12/19 |
Recruiting (n = 120) * |
Interventional Randomized |
FLiO diet versus control diet | NAFLD and obesity | Nutritional/lifestyle interventions to identify non-invasive biomarkers to early diagnosis of NAFLD in future obese people | Centre for Nutrition Research, University of Navarra Pamplona, Navarra, Spain |
|
NCT03135873 03/17–12/19 |
Recruiting (n = 52) * |
Interventional Randomized (Phase I) |
Mastiha vs. placebo | Obese NAFLD | Explore gene-diet interactions and correlate genetic/epigenetic markers with metabolome and gut microbiota | Harokopio University, Athens, Attica, Greece |
|
NCT02837367 06/19–12/19 |
Recruiting (n = 600) * |
Interventional Randomized |
Administration of supplements containing methyl-donors | Obesity and dyslipidemia | Explore the genetic signature involved in the donation of methyl groups and unsaturated omega-6/3 fatty acid metabolism | Clinica II Pediatrie Bega Timisoara, Timis, Romania. Spitalul Judetean Timisoara; Centrul de Diabet Timisoara, Timis, Romania |
* Estimated number of participants.