NCT01712867已完成不适用
The Effect of Phytosterol Esters of Omega-3 (Vayarol) Versus Omega-3 Acids Ethyl Esters in Reducing Triglyceride Levels in Hypertriglyceridemia Patients: A Double-blind, Randomized, Noninferiority Trial
Enzymotec1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2012年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- fasting triglycerides levels
研究概览
简要总结
The primary objective is to determine the efficacy of phytosterol esters of omega-3 (Vayarol) versus Omega-3 acids ethyl esters in reducing triglyceride levels in hypertriglyceridemia patients with fasting triglyceride levels ≥ 200 and < 500 mg/dL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Male or female, age > 18 years
- •Triglycerides ≥ 200 mg/dL and < 500 mg/dL
- •Ability to give written informed consent
排除标准
- •Female patient who are pregnant or breastfeeding or planning to become pregnant
- •Fasting plasma glucose (FPG) levels > 110 mg/dL
- •Type 2 diabetes mellitus that is poorly controlled (glycosylated hemoglobin [HbAlc ] >8.0%
- •Patients who are under use of lipid altering drugs excluding use of Simvastatin, Atorvastatin, and Rosovastatin for 6 weeks or more
- •Patients who are under use of products containing omega-3 fatty acids or other dietary supplements with potential lipid altering effects
- •History of bariatric surgery or currently on weight loss drugs.
- •Uncontrolled hypertension (BP>140/90)
- •Subjects with secondary causes of hypertriglyceridemia: alcoholism, dysglobulinemia, thyroid disease that is poorly controlled (TSH<0.35 or TSH>5.5)
- •Subjects with an abnormal level of liver enzymes (twice the normal level)
- •Suffered from ischemic event such as myocardial infarction, cerebrovascular accident and angina pectoris in the last 6 months
- •Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins such as cushing syndrome
- •Gastrointestinal disease that may influence lipid metabolism such as celiac, crohn, colitis or other malabsorption problem
- •Subjects who have had any malignancy. Subjects who have had basal cell carcinoma that have been disease free for at least 3 years are eligible for the study.
- •Consumption of one fish serving (200 grams) or sea food x2 a week or more.
- •HIV infection by history
- •History of hypersensitivity or allergy to fish, fish oil or soy
- •Weight change > 3 kg during the run-in period
- •Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient
研究组 & 干预措施
Phytosterol esters of omega-3
Experimental
4 capsules/day for 12 weeks
干预措施: Phytosterol esters of omega-3 (Other)
Omega-3 acid ethyl esters
Active Comparator
4 capsules/day for 12 weeks
干预措施: Omega-3 acid ethyl esters (Other)
结局指标
主要结局
fasting triglycerides levels
时间窗: 12 weeks
Noninferiority of phytosterol esters of omega-3 in affecting plasma fasting triglyceride levels in comparison with Omega-3 acids ethyl esters.
次要结局
- Difference between phytosterol esters of omega-3 and Omega-3 acids ethyl esters treatment groups in other lipid and biomarker levels(12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
ipid lowering potential of combined phytosterols and long chain omega-3 fatty acidsHyperlipidaemiaBlood - Other blood disordersACTRN12606000453583The University of Newcastle60
已完成
不适用
Phytosterol Supplementation and Lipoprotein SubfractionsPrimary PreventionHypercholesterolemiaNCT06127732Federal University of São Paulo23
尚未招募
不适用
The Role of Plant-Based Omega-3 Fatty Acids and Molecular Characterisation in Individuals with Cardiovascular(CVD) RiskCardiovascular RiskNCT05882266Universiti Putra Malaysia72
招募中
不适用
Impact of Omega 3 in Alcohol Use DisorderAlcohol Use Disorder, SevereNCT05899660Université Catholique de Louvain100
已完成
4 期
Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid LevelsDyslipidemiaNCT00441480Enzymotec91