Clinical trial NCT03625284: Oral Dietary Fucoxanthin Rich Supplement for Liver Health
Official title: Oral Dietary Fucoxanthin Rich Supplement for Liver Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Alcoholic Fatty Liver
Keywords: fucoxanthin
microalgae
non alcoholic fatty liver
Lead sponsor: Algatechnologies Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Assaf-Harofeh Medical Center
First posted: 2018-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Blind, placebo-controlled study testing the hypothesis that oral dietary supplement rich with fucoxanthin will decrease biochemical clinical markers related to liver health.

Detailed description: Six month supplementation

Eligibility criteria: Inclusion Criteria:

* Healthy adults \> 18 years
* Willing to sign an informed consent to participate in the study.
* Non-smokers.
* Blood results above the normal range in hepatic function testing consisting of panels containing ALT, AST, ALP, total bilirubin and albumin and abdominal ultrasonography.
* Over-weight (BMI ≥ 27 kg/m2) who fulfill the criteria of the National Cholesterol Education Program (NCEP) metabolic syndrome.

Exclusion Criteria:

* Pregnancy.
* Presence of gastrointestinal or mental disorders, diabetes mellitus, alcohol abuse, weight-loss treatment, bariatric surgery, unusual diets (vegetarian, vegan), daily usage of antioxidants dietary supplements at the last 4 months (for subjects in stage 2 of the study).
* Serious medical conditions.

Primary outcomes:
measure: Liver function test: Serum Alanine transaminase (ALT)
timeFrame: week 0,12,24
measure: Liver function test: Aspartate transaminase (AST)
timeFrame: week 0,12,24
Secondary outcomes:
measure: Liver function test:Blood gamma-glutamyl transferase (GGT)
timeFrame: week 0,12,24
measure: Liver function test:Blood albumin
timeFrame: week 0,12,24
measure: Liver function test: Blood bilirubin
timeFrame: week 0,12,24
measure: Hepatic steatosis
timeFrame: 0, 24 week
measure: Weight
timeFrame: week 0,12,24
measure: Waist circumference
timeFrame: week 0,12,24
measure: Serum lipid profile
timeFrame: week 0,12,24
measure: Blood glucose status
timeFrame: week 0,12,24
measure: Inflammation
timeFrame: week 0,12,24
measure: Kidney function test: serum creatinine
timeFrame: week 0,12,24
measure: Kidney function test: Glomerular Filtration Rate(GFR)
timeFrame: week 0,12,24
measure: Kidney function test: Blood Urea Nitrogen
timeFrame: week 0,12,24
measure: Dietary supplement level in the blood
timeFrame: week 0,6 or 12,24
Other outcomes:
Locations:
Study officials:
affiliation: Director Institute of Gastroenterolgy, Liver Diseases and Nutrition
name: Haim Shirin, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.