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| Name | Class |
|---|---|
| Assaf-Harofeh Medical Center | OTHER_GOV |
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Blind, placebo-controlled study testing the hypothesis that oral dietary supplement rich with fucoxanthin will decrease biochemical clinical markers related to liver health.
Six month supplementation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fucovital | Experimental | capsules of a dietary supplement rich with fucoxanthin from microalgae extract |
|
| Placebo | Placebo Comparator | capsules of an edible oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Edible oil |
| |
| FucoVital |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function test: Serum Alanine transaminase (ALT) | Change from baseline of liver enzymes | week 0,12,24 |
| Liver function test: Aspartate transaminase (AST) | Change from baseline of liver enzymes | week 0,12,24 |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function test:Blood gamma-glutamyl transferase (GGT) | change from baseline | week 0,12,24 |
| Liver function test:Blood albumin | change from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tair Lapidot, Dr | Contact | +972548095209 | tair@algatech.com | |
| Marina Beder | Contact | marinabe@asaf.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Haim Shirin, Prof. | Director Institute of Gastroenterolgy, Liver Diseases and Nutrition | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33993853 | Derived | Yang M, Xuan Z, Wang Q, Yan S, Zhou D, Naman CB, Zhang J, He S, Yan X, Cui W. Fucoxanthin has potential for therapeutic efficacy in neurodegenerative disorders by acting on multiple targets. Nutr Neurosci. 2022 Oct;25(10):2167-2180. doi: 10.1080/1028415X.2021.1926140. Epub 2021 May 15. |
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| 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 |
|---|---|
| C025164 | fucoxanthin |
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| Dietary Supplement |
Microalgae oil extract |
|
|
| week 0,12,24 |
| Liver function test: Blood bilirubin | change from baseline | week 0,12,24 |
| Hepatic steatosis | Change from baseline by ultrasound | 0, 24 week |
| Weight | Change from baseline | week 0,12,24 |
| Waist circumference | Change from baseline | week 0,12,24 |
| Serum lipid profile | Change from baseline total cholesterol, triglycerides, low density lipoprotein (LDL) (HDL) fractions | week 0,12,24 |
| Blood glucose status | Change from baseline of HbA1c | week 0,12,24 |
| Inflammation | Change from baseline of CRP | week 0,12,24 |
| Kidney function test: serum creatinine | Change from baseline | week 0,12,24 |
| Kidney function test: Glomerular Filtration Rate(GFR) | Change from baseline | week 0,12,24 |
| Kidney function test: Blood Urea Nitrogen | Change from baseline | week 0,12,24 |
| Dietary supplement level in the blood | Determination of Fucoxanthin metabolite in plasma by LC-MS/MS | week 0,6 or 12,24 |