Last reviewed · How we verify
NCT02366052: NucesNASH
Nutritional Counseling vs. Nutritional Supplements for NASH - a Randomized Prospective, Open Label Pilot Study
Phase 2 trial testing Nutritional Counseling in Non-alcoholic Fatty Liver Disease in 42 participants. Completed in 10 May 2017.
10 May 2017
Quick facts
| Lead sponsor | Johannes Gutenberg University Mainz |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 1 February 2015 |
| Primary completion | 10 May 2017 |
| Estimated completion | 10 May 2017 |
| Sites | 2 locations across Germany |
Drugs / interventions tested
- Nutritional Counseling
- Lactobacillus casei shirota (LCS)
- Nutritional Counseling and LCS
Conditions studied
- Non-alcoholic Fatty Liver Disease — all drugs for Non-alcoholic Fatty Liver Disease →
- Fatty Liver, Nonalcoholic — all drugs for Fatty Liver, Nonalcoholic →
Sponsor
Johannes Gutenberg University Mainz
Who can join
Adults 18 to 75, any sex, with Non-alcoholic Fatty Liver Disease or Fatty Liver, Nonalcoholic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main aim of the study is to determine if an oral supplementation of the LCS has a beneficial effect by itself or even enhances the beneficial effects of a moderate life-style intervention on the progression of NAFLD in humans.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Adipokines and Endotoxemia Correlate with Hepatic Steatosis in Non-Alcoholic Fatty Liver Disease (NAFLD).
Nier A, Huber Y, Labenz C, Michel M, et al · · 2020 · cited 36× · PMID 32151020 · DOI 10.3390/nu12030699 -
Lifestyle modifications for nonalcohol-related fatty liver disease: a network meta-analysis.
Buzzetti E, Linden A, Best LM, Madden AM, et al · · 2021 · cited 28× · PMID 34114650 · DOI 10.1002/14651858.cd013156.pub2 -
Toll-like receptor 1 as a possible target in non-alcoholic fatty liver disease.
Baumann A, Nier A, Hernández-Arriaga A, Brandt A, et al · · 2021 · cited 24× · PMID 34497333 · DOI 10.1038/s41598-021-97346-9 -
Nutritional supplementation for nonalcohol-related fatty liver disease: a network meta-analysis.
Komolafe O, Buzzetti E, Linden A, Best LM, et al · · 2021 · cited 12× · PMID 34280304 · DOI 10.1002/14651858.cd013157.pub2
Verify or expand the search:
- PubMed search for NCT02366052
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nutritional Counseling
Trials testing the same drug.
- NCT07479940 — Obesity and Aging: Impacts of Nutritional Counseling and Physical Exercise on Telomeres and Senescence Parameters · NA · active not recruiting
- NCT06784310 — Food Insecurity, Social Determinants of Health · NA · completed
- NCT06610097 — TNBC Gut Microbiota During Neoadjuvant Treatment · NA · recruiting
- NCT06751290 — The Use of Cyproheptadine in Pediatric Feeding Disorders · Phase 4 · active not recruiting
- NCT06673342 — Effectiveness of a Nutritional Counseling Tool in Reducing the Amount and Frequency of Sugar Intake · NA · completed
Other recruiting trials for Non-alcoholic Fatty Liver Disease
Currently open trials in the same condition.
- NCT07358546 — A Study of Efimosfermin Alfa in Adults With Hepatic Impairment · Phase 1 · recruiting
- NCT07335198 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a · Phase 1 · recruiting
- NCT07221188 — A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or · Phase 3 · recruiting
- NCT07221227 — A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH · Phase 3 · recruiting
- NCT07514377 — JiGenerations Health Cohort Study：Parental Exposure and Intergenerational Health in China · active not recruiting
Other Johannes Gutenberg University Mainz trials
Trials by the same sponsor.
- NCT06269874 — Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment · NA · not yet recruiting
- NCT07076511 — A Novel Intuitive Airway Trolley for Quick Decision-making in Simulated Unexpected Difficult Airway Situations: Evaluati · NA · completed
- NCT06739993 — Effects of Autonomic Nervous System Modulation by Heart Rate Variability Biofeedback Training With Resonant Frequency Br · NA · recruiting
- NCT06514495 — Differential Effects of in Vivo and Virtual Exposure Therapy in Agoraphobia · NA · recruiting
- NCT07460791 — Alcon Hydrus Stent Implantation - Long Term Follow up After 8 Years · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02366052 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johannes Gutenberg University Mainz
- Last refreshed: 16 May 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02366052.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing