Clinical Study to Evaluate the Effectiveness and Safety of the Consumption of a Food Supplement in a Group of Healthy People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in ex vivo cytokine profile produced by lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells (PBMCs)
研究概览
简要总结
Bioactive supplements might display relevant therapeutic properties according to validated molecular effects. Herein, the effect of a supplement based on diterpenes from Rosmarinus Officinalis L. and alkylglycerols with proven properties against signaling pathways involved in tumorigenesis is evaluated. The biological and molecular effects of this supplement, mainly based on expected effects on immune and genetic modulatory properties is investigated. For this purpose, 60 healthy volunteers were enrolled in a six week, double-blind, randomized and parallel pilot study with two study arms -rosemary and alkylglycerol containing capsules and control capsules. The study includes the analysis of (1) immunological parameters (ex vivo cytokine profile of LPS stimulated PBMC and PBMC phenotyping by cluster differentiation (CD) markers), (2) regulation of the expression of genes linked to immuno-modulation, inflammation, oxidative stress response and cancer, and (3) the analysis of correlation of selected genetic variants (SNPs) with the differential responses among individuals.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 55 years
- •Adequate understanding of the study.
- •Willingness to complete the entire treatment.
排除标准
- •Diagnosis of type 2 diabetes mellitus (T2D), hypertension, dyslipidemia or other cardiometabolic disorders
- •Impaired cognitive function;
- •Diagnosed hepatic, renal, or cardiovascular disease
- •Subjects with primary immunodeficiency disorders, consumption of drugs with influence on the immune system, splenectomy.
- •Presence of other pathologies like asthma, food allergies, Crohn's, myasthenia gravis, lupus
- •Consumption of vitamins, minerals, supplements of antioxidant extracts or protein supplements in the 2 weeks prior to the start of the study
- •Subjects treated with drugs affecting the lipid or glycemic profile during the previous 30 days
- •Consumption of anticoagulants or antiplatelet agents, cyclosporine, acetylsalicylic acid, antihistamines or sedatives
- •Hypersensitivity to rosemary, to its components or other members of the family of lipped plants or to soybean as excipient of the capsules
- •Allergy or hypersensitivity to fish
- •Habitual smoking or high consumption alcohol
- •Pregnant or lactating women
- •High-intensity physical exercise.
研究组 & 干预措施
Rosemary and alkylglycerol capsules
干预措施: Dietary supplementation with capsules containing rosemary and alkylglycerol (Dietary Supplement)
Control capsules
干预措施: Dietary supplementation with control capsules (Dietary Supplement)
结局指标
主要结局
Changes in ex vivo cytokine profile produced by lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells (PBMCs)
时间窗: Baseline and after 6 weeks of treatment
Isolated PBMCs were first incubated for 12h, and then after LPS treated. Supernatants were recovered to determine concentrations of Interleukin (IL) -1B, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IFNy and TNFa using a magnetic bead-based immunoassay (Human High Sensitivity T Cell Magnetic Bead Panel A MAGPIX-Luminex) kit from Millipore, following the manufacturer's instructions. A minimum of 50 beads per parameter was analyzed by the MAGPIX-Luminex system. Raw data (median fluorescence intensity, MFI) were analyzed with the xPONENT software 4.1.
次要结局
- Changes in oxidative stress status(Baseline and after 6 weeks)
- Changes in lipid profile(Baseline and after 6 weeks)
- Gene expression analysis(Baseline and after 6 weeks)
- DNA genotyping(Baseline)