Oral Dietary Fucoxanthin Rich Supplement for Liver Health

Non Alcoholic Fatty Liver Clinical Trial

Official title:

Oral Dietary Fucoxanthin Rich Supplement for Liver Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03625284
• Other study ID #: Clinical protocol FUCO 02
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: December 10, 2019

Study information

• Verified date: July 2018
• Source: Algatechnologies Ltd.
• Contact: Tair Lapidot, Dr
• Phone: +972548095209
• Email: tair[@]algatech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Six month supplementation

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 10, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Fatty Liver
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Placebo
Edible oil
• FucoVital
Microalgae oil extract

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Algatechnologies Ltd.	Assaf-Harofeh Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver function test: Serum Alanine transaminase (ALT)	Change from baseline of liver enzymes	week 0,12,24
Primary	Liver function test: Aspartate transaminase (AST)	Change from baseline of liver enzymes	week 0,12,24
Secondary	Liver function test:Blood gamma-glutamyl transferase (GGT)	change from baseline	week 0,12,24
Secondary	Liver function test:Blood albumin	change from baseline	week 0,12,24
Secondary	Liver function test: Blood bilirubin	change from baseline	week 0,12,24
Secondary	Hepatic steatosis	Change from baseline by ultrasound	0, 24 week
Secondary	Weight	Change from baseline	week 0,12,24
Secondary	Waist circumference	Change from baseline	week 0,12,24
Secondary	Serum lipid profile	Change from baseline total cholesterol, triglycerides, low density lipoprotein (LDL) (HDL) fractions	week 0,12,24
Secondary	Blood glucose status	Change from baseline of HbA1c	week 0,12,24
Secondary	Inflammation	Change from baseline of CRP	week 0,12,24
Secondary	Kidney function test: serum creatinine	Change from baseline	week 0,12,24
Secondary	Kidney function test: Glomerular Filtration Rate(GFR)	Change from baseline	week 0,12,24
Secondary	Kidney function test: Blood Urea Nitrogen	Change from baseline	week 0,12,24
Secondary	Dietary supplement level in the blood	Determination of Fucoxanthin metabolite in plasma by LC-MS/MS	week 0,6 or 12,24