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| ID | Type | Description | Link |
|---|---|---|---|
| SCHA 1015/5-1 | Other Grant/Funding Number | DFG |
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| Name | Class |
|---|---|
| University of Jena | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Counseling | Active Comparator | The nutritional counseling group will receive dietary counseling focusing on a reduction of fructose intake by a trained nutritionist for 12 weeks every 3 weeks. |
|
| Nutritional Counseling and LCS | Experimental | The dietary supplement LCS (Lactobacillus casei shirota ) will be given 2 times a day for 12 weeks in addition to the nutritional counseling every 3 weeks. |
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| Lactobacillus Casei Shirota | Experimental | The dietary supplement LCS (Lactobacillus casei shirota ) will be given 2 times a day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Counseling | Behavioral | Nutritional counseling by a trained nutritionist for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the M30 antigen in the serum | Reduction of the M30 antigen as a validated measure of the degree of hepatocellular inflammation and injury | 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in indicators of hepatocellular injury and fibrosis | Change in indicators of hepatocellular injury (ALT, gammaGT, M30/M60 antigen ratio, ELF score), proinflammatory cytokines (hsCRP, ferritin, plasminogen activator-1, endotoxin), surrogate parameters of liver fibrosis (fibrosis marker panels, Fibrotest, ELF score) and relative liver stiffness (assessed by Fibro Scan) | 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in measures of nutritional physiology | Improvement of nutritional physiology, compliance, self-perceived efficacy, emotional eating behavior using a validated questionnaires. | 12 and 24 weeks |
Inclusion Criteria:
- Elevated M30 antigen levels (cutoff: >200 - 800 U/L) at screening AND hepatic steatosis on ultrasound
OR histologically confirmed NASH
- Age 18 to 75 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jörn M Schattenberg, MD | Johannes Gutenberg Universität | Principal Investigator |
| Ina Bergheim, PhD | Universität Jena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Ernährungswissenschaften, University Jena | Jena | 07743 | Germany | |||
| University Medical Center of the Johannes Gutenber Univeristy |
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| Lactobacillus casei shirota (LCS) | Dietary Supplement | The dietary supplement LCS (Yakult plus) will be given 2 times a day for 12 weeks in addition to dietary counseling every 3 weeks. |
|
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| Nutritional Counseling and LCS | Other | Nutritional counseling by a trained nutritionist in addition to the dietary supplement LCS (2 times a day) for 12 weeks. |
|
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| Change in metabolic risk factors | Changes in metabolic risk factors (BMI, waist circumference, Homeostasis Model Assessment/Matsuda Score, serum lipids), changes in oral glucose tolerance and changes in hepatic steatosis will be assessed. | 12 and 24 weeks |
| Saftey and tolerability | Safety is assessed by (1) clinical examination, (2) clinical chemistries including serum electrolytes, renal, liver function tests and markers of pancreatic injury. | 12 and 24 weeks |
| Mainz |
| 55131 |
| Germany |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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