Effect of the Adapted Brazilian Cardioprotective Diet Supplemented With Phytosterols and/or Krill Oil in Patients With Familial Hypercholesterolemia: DICA-HF Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 17
- 主要终点
- LDL-c
研究概览
简要总结
The main objective of this pilot study is to evaluate the effects of the Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or definitive diagnosis of familial hypercholesterolemia (FH) identified by the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ complete sequencing of the exome; to evaluate the effects of the interventions on lipid profile; to identify subclasses of low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol; to perform untargeted lipidomic analyses; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; and to evaluate both implementation components and adherence rates to the protocol, aiming to design a larger randomized trial. In this pilot study, between 48 and 76 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to FH (DICA-HF) + phytosterol placebo + krill oil placebo (control group); 2) DICA-HF + 2g/day of phytosterol + krill oil placebo; 3) DICA-HF + phytosterol placebo + 2g/day of krill oil; and 4) DICA-HF + 2g/day of phytosterol + 2g/day of krill oil. Primary outcomes will be LDL-cholesterol for groups phytosterol vs. placebo and lipoprotein(a) for groups krill oil vs. placebo after 120 days of follow up.
World Health Organization Universal Trial Number (WHO-UTN): U1111-1296-7102
详细描述
DICA-HF pilot study is a superiority, factorial, and in parallel randomized placebo-controlled (double-dummy) clinical trial. The randomization will be in blocks of varying sizes stratified by research center, and the allocation ratio will be 1:1:1:1. Participants will come from at least 9 center sites in different Brazilian geographic regions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants (age ≥20 years);
- •Definitive (certainty) or probable diagnosis of FH by the Dutch MEDPED criteria;
- •Using one of the following treatment regimens for ≥ 6 weeks: simvastatin 40 mg; lovastatin 40 mg; pravastatin 80 mg; atorvastatin 20 mg; rosuvastatin 10 mg; pitavastatin 4 mg; fluvastatin 80 mg; atorvastatin 40 - 80 mg; rosuvastatin 20 - 40 mg; atorvastatin 40 - 80 mg + ezetimibe 10mg; rosuvastatin 20 - 40 mg + ezetimibe 10mg; or simvastatin 40mg + ezetimibe 10mg.
排除标准
- •"Possible" diagnosis of FH according to the Dutch MEDPED criteria;
- •Fasting triglycerides ≥ 500mg/dL;
- •Diagnosis of hypercholesterolemia due to a secondary cause (hypothyroidism, nephrotic syndrome, etc.);
- •Food allergies (food, dyes, preservatives);
- •Contraindication to the use of phytosterols (for example: diagnosis of sitosterolemia);
- •HIV positive in treatment/AIDS;
- •Chronic inflammatory diseases;
- •Liver disease or chronic kidney disease on dialysis;
- •Cancer under treatment or life expectancy < 6 months;
- •Episode of acute coronary syndrome in the last 60 days;
- •Chemical dependency/alcoholism;
- •Chronic use of anti-inflammatory, anticonvulsant and immunosuppressive drugs;
- •Use of PCSK9 inhibitors (alirocumab and evolocumab);
- •Pregnancy or lactation;
- •Wheelchair users unable to undergo anthropometric assessment;
- •Body mass index ≥40kg/m²;
- •Use of dietary supplements that may interfere with the outcomes of interest;
- •Participation in other randomized clinical trials;
- •Refusal to participate in the study.
研究组 & 干预措施
DICA-HF + phytosterol + krill oil
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of phytosterol and 2g/day of krill oil during 120 days.
干预措施: krill oil (Dietary Supplement)
DICA-HF + placebo
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus placebo of both phytosterol and krill oil during 120 days.
干预措施: Placebo krill oil (Other)
DICA-HF + placebo
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus placebo of both phytosterol and krill oil during 120 days.
干预措施: Placebo phytosterol (Other)
DICA-HF + phytosterol
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of phytosterol and placebo of the krill oil during 120 days.
干预措施: phytosterol (Dietary Supplement)
DICA-HF + phytosterol
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of phytosterol and placebo of the krill oil during 120 days.
干预措施: Placebo krill oil (Other)
DICA-HF + krill oil
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of krill oil and placebo of phytosterol during 120 days.
干预措施: Placebo phytosterol (Other)
DICA-HF + phytosterol + krill oil
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of phytosterol and 2g/day of krill oil during 120 days.
干预措施: phytosterol (Dietary Supplement)
DICA-HF + krill oil
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of krill oil and placebo of phytosterol during 120 days.
干预措施: krill oil (Dietary Supplement)
结局指标
主要结局
LDL-c
时间窗: 120 days
Low-density lipoprotein cholesterol, in mg/dL
Lp(a)
时间窗: 120 days
Lipoprotein(a), in mg/dL
Adherence
时间窗: 120 days
Adherence to treatment, evaluated by: attendance at consultations (at least 3 of the 4 planned study visits); plasma concentrations of phytosterols and erythrocyte levels of EPA/DHA fatty acids (identified by the difference between the last and the first study visits); and counting the consumed products under investigation (consumption of at least 80% of the capsules provided to the participants, regardless of the allocation group).
次要结局
- TC(120 days)
- VLDL(120 days)
- CI II(120 days)
- CI I(120 days)
- TG/HDL-c(120 days)
- ox-LDL(120 days)
- Implementation(120 days)
- NHDL(120 days)
- HDL-c(120 days)
- TG(120 days)
- AE(120 days)
- AI(120 days)