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Oral Dietary Fucoxanthin Rich Supplement for Liver Health

Sponsor
Algatechnologies Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03625284
Collaborator
Assaf-Harofeh Medical Center (Other)
30
Enrollment
2
Arms
15
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Placebo
  • Dietary Supplement: FucoVital
 N/A

Detailed Description

Six month supplementation

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Oral Dietary Fucoxanthin Rich Supplement for Liver Health
Anticipated Study Start Date :
Sep 10, 2018
Anticipated Primary Completion Date :
Sep 10, 2019
Anticipated Study Completion Date :
Dec 10, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fucovital

capsules of a dietary supplement rich with fucoxanthin from microalgae extract

Dietary Supplement: FucoVital
Microalgae oil extract
Other Names:
  • fucoxanthin

    		•
    Placebo Comparator: Placebo

    capsules of an edible oil

    Dietary Supplement: Placebo
    Edible oil

    Dietary Supplement: FucoVital
    Microalgae oil extract
    Other Names:
  • fucoxanthin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Liver function test: Serum Alanine transaminase (ALT) [week 0,12,24]

      Change from baseline of liver enzymes

    2. Liver function test: Aspartate transaminase (AST) [week 0,12,24]

      Change from baseline of liver enzymes

    Secondary Outcome Measures

    1. Liver function test:Blood gamma-glutamyl transferase (GGT) [week 0,12,24]

      change from baseline

    2. Liver function test:Blood albumin [week 0,12,24]

      change from baseline

    3. Liver function test: Blood bilirubin [week 0,12,24]

      change from baseline

    4. Hepatic steatosis [0, 24 week]

      Change from baseline by ultrasound

    5. Weight [week 0,12,24]

      Change from baseline

    6. Waist circumference [week 0,12,24]

      Change from baseline

    7. Serum lipid profile [week 0,12,24]

      Change from baseline total cholesterol, triglycerides, low density lipoprotein (LDL) (HDL) fractions

    8. Blood glucose status [week 0,12,24]

      Change from baseline of HbA1c

    9. Inflammation [week 0,12,24]

      Change from baseline of CRP

    10. Kidney function test: serum creatinine [week 0,12,24]

      Change from baseline

    11. Kidney function test: Glomerular Filtration Rate(GFR) [week 0,12,24]

      Change from baseline

    12. Kidney function test: Blood Urea Nitrogen [week 0,12,24]

      Change from baseline

    13. Dietary supplement level in the blood [week 0,6 or 12,24]

      Determination of Fucoxanthin metabolite in plasma by LC-MS/MS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Algatechnologies Ltd.
    • Assaf-Harofeh Medical Center

    Investigators

    • Principal Investigator: Haim Shirin, Prof., Director Institute of Gastroenterolgy, Liver Diseases and Nutrition

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Algatechnologies Ltd.
    ClinicalTrials.gov Identifier:
    NCT03625284
    Other Study ID Numbers:
    • Clinical protocol FUCO 02
    First Posted:
    Aug 10, 2018
    Last Update Posted:
    Aug 14, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Algatechnologies Ltd.
    fucoxanthin
    microalgae
    non alcoholic fatty liver
    Additional relevant MeSH terms:
    Fatty Liver
    Non-alcoholic Fatty Liver Disease

    Study Results

    No Results Posted as of Aug 14, 2018