NCT03625284Unknown不适用
Oral Dietary Fucoxanthin Rich Supplement for Liver Health
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Liver function test: Serum Alanine transaminase (ALT)
研究概览
简要总结
Blind, placebo-controlled study testing the hypothesis that oral dietary supplement rich with fucoxanthin will decrease biochemical clinical markers related to liver health.
详细描述
Six month supplementation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Fucovital
Experimental
capsules of a dietary supplement rich with fucoxanthin from microalgae extract
干预措施: FucoVital (Dietary Supplement)
Placebo
Placebo Comparator
capsules of an edible oil
干预措施: Placebo (Dietary Supplement)
Placebo
Placebo Comparator
capsules of an edible oil
干预措施: FucoVital (Dietary Supplement)
结局指标
主要结局
Liver function test: Serum Alanine transaminase (ALT)
时间窗: week 0,12,24
Change from baseline of liver enzymes
Liver function test: Aspartate transaminase (AST)
时间窗: week 0,12,24
Change from baseline of liver enzymes
次要结局
- Liver function test:Blood gamma-glutamyl transferase (GGT)(week 0,12,24)
- Liver function test:Blood albumin(week 0,12,24)
- Liver function test: Blood bilirubin(week 0,12,24)
- Hepatic steatosis(0, 24 week)
- Weight(week 0,12,24)
- Waist circumference(week 0,12,24)
- Serum lipid profile(week 0,12,24)
- Blood glucose status(week 0,12,24)
- Inflammation(week 0,12,24)
- Kidney function test: serum creatinine(week 0,12,24)
- Kidney function test: Glomerular Filtration Rate(GFR)(week 0,12,24)
- Kidney function test: Blood Urea Nitrogen(week 0,12,24)
- Dietary supplement level in the blood(week 0,6 or 12,24)
研究者
相似试验
已完成
不适用
Safety and Efficacy of a Flavonoids- and omega3s-based Compound for the Treatment of Muscular DystrophiesMuscular DystrophiesMuscle InflammationNCT03317171Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico29
招募中
不适用
Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and ElasticityPhotoagingNCT05882084Integrative Skin Science and Research24
已完成
不适用
Study to Evaluate the Safety and Efficacy of a Proprietary "Joint Health" Dietary Supplement in Subjects With Joint and Connective Tissue PainJoint PainNCT03209895U.S. Nutraceuticals, LLC135
招募中
不适用
Clinical Trial on a Food Supplement With Melatonin and Herbal Products to Improve Sleep QualitySleep DisordersNCT05459272Uriach Consumer Healthcare50
终止
不适用
Effect of Consuming a Bioactive Compound (EPP) on Joint Health in Healthy AdultsKnee DiscomfortNCT06650670Biosearch S.A.37