| Trial ID: | L0705 |
| Source ID: | NCT04308980
|
| Associated Drug: |
SPP-1
|
| Title: |
Development and Evaluation of the Effectiveness of Complex Therapy of Steatohepatitis of Various Aetiologies Based on Metabolomic Analysis With the Use of Innovative Medical Nutrition Products
|
| Acronym: |
52920190055
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NAFLD;NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
Dietary Supplement: Specialized product for medical nutrition (SPP-1);Behavioral: individualized diet
|
| Outcome Measures: |
Weight change;Change of satiety level;Change of hunger level;Presence of adverse events;Change of proportion of fat in body composition;Change of proportion of water in body composition;Change of lean body weight;Change in blood docosahexaenoic acid concentration;Change in blood hydroxyeycosatetraenoic acid concentrationChange of serum glucose concentration;Change of serum insulin concentration;Change of serum triglycerides concentration;Change of serum high-density lipoprotein concentration;Change of serum low-density lipoprotein concentration;Change of serum cholesterol concentration;Change of serum gamma-glutamine transpeptidase (GGT) activity level;Change of serum alanine amino-transferase (AST) activity level;Change of serum alanine amino-transferase (ALT) activity
|
| Sponsor/Collaborators: |
Russian Academy of Medical Sciences
|
| Gender: |
All
|
| Age: |
18 Years70 Years
|
| Phases: |
Phase 2/Phase 3
|
| Enrollment: |
45
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
12/03/2020
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
16 February 2021
|
| Locations: |
Russian Federation
|
| URL: |
https://clinicaltrials.gov/show/NCT04308980
|
