Systemic and Intestinal Therapeutic Target Bioactivity of a Functional Beverage Containing β-cryptoxanthin (β-Cx), Plant Sterols (PS) and Galactooligosaccharides (GOS): "in Vivo" and "in Vitro" Studies.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Serum levels of PS
研究概览
简要总结
Regular consumption of a beverage containing β-cryptoxanthin (β-Cx) and plant sterols (PS) has been shown to exert a synergic effect in reducing some markers of cardiovascular risk and bone-remodeling (formation and resorption). The present project aims to:
- Evaluate (by in vivo and in vitro studies) the bioavailability of added β-Cx, PS and galactooligosaccharides (GOS) and its stability in the beverage employed in the proposed study.
- Study the biological effect (bioefficacy) associated with the regular consumption of modified milk-based fruit beverages containing β-Cx, PS and GOS in post-menopausal women (target group) by assessing changes in inflammation, cardiovascular and bone turnover biochemical markers.
- Characterize genetic variability (polymorphisms), genetic expression and DNA oxidative damage in the target group as determinants of bioavailability and biological effects of β-Cx, PS and GOS.
- Evaluate the potential prebiotic effect associated to regular consumption of a beverage supplemented with β-Cx, PS and GOS: including "in vitro" studies and characterization of subjects' microbiota and possible microbiota changes associated to the beverage consumption.
详细描述
A previous Clinical Trial (AGL2012-39503-C02) evidenced the beneficial synergic effects upon bone remodeling and cardiovascular risk of a beverage, based on juice and milk, and enriched with PS and β-Cx. "In vitro" and "in vivo" (clinical) studies have confirmed low absorption of PS and β-Cx in this beverage, with possible slight modification of the sterols and metabolites by the intestinal microbiota. PS and β-Cx can reach the colon and be transformed by the intestinal microbiota with resulting beneficial effects.
The new Clinical Trial aims to determine whether the presence of galactooligosaccharides (GOS) in a beverage containing PS and β-Cx might modulate the biological effects of these latter components at either intestinal level (modification of microbiota and inflammatory markers) or systemically (blood cholesterol-lowering effect and bone turnover).
In the present clinical interventional study we will evaluate the systemic biological effects of a beverage containing GOS, PS and β-Cx, as well as its intestinal effects and its influence on the microbiota in postmenopausal women. Furthermore, we will study the stability and bioavailability of PS and β-Cx in the beverage.
The clinical study will help to confirm whether the new GOS-containing beverage has effects upon cardiovascular risk markers, bone remodeling and inflammation at least equivalent to those observed with the beverage studied in the previous Clinical Trial.
The results obtained will generate interesting information for improving beverage formulation with bioactive components that might be relevant for food industry. Furthermore, clarifying the beneficial effects of the studied beverages is relevant not only for healthy subjects but also for those with certain disease conditions (i.e., intestinal inflammation diseases), and may contribute to improve their wellbeing and health, with the consequent social and economic benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age (45-65 years), BMI<35 Kg/m2, amenorrhea over 12 months, non-dieting and non-intake of vitamin D, calcium and ω-3 fatty acids and PS or vitamin-enriched foods or supplements or other dietary bioactive components.
排除标准
- •Use of vitamins, hormone replacement therapy, fibrates, statins and a weight losing diet, as well as acute inflammation, chronic medication and infection or intercurrent illness capable of affecting the bioavailability or status of the compounds of interest.
研究组 & 干预措施
β-Cx plus PS
Fruit and milk based beverage enriched with beta-cryptoxanthin and plant sterols
干预措施: β-Cx plus PS (Dietary Supplement)
β-Cx plus PS plus GOS
Fruit and milk bases beverage enriched with beta-criptoxanthin, plant sterols and galactooligosaccharides
干预措施: β-Cx plus PS plus GOS (Dietary Supplement)
结局指标
主要结局
Serum levels of PS
时间窗: 6 weeks
Serum levels of β-Cx
时间窗: 6 weeks
次要结局
- Serum lipid profile(6 weeks)
- C reactive protein, ferritin, calprotectin, alpha-1-antitrypsin, alpha-1-acid(6 weeks)
- Beta C-terminal telopeptide (beta-CrossLaps/betaCTx), osteoprotegerin, Parathyroid hormone (PTH), calcium, phosphorus, Alkaline phosphatase(6 weeks)
- Sterol fecal levels(6 weeks)
- β-cryptoxanthin fecal levels(6 weeks)
- Interleukins(6 weeks)
- beta-carotene oxygenase 1 (BCO1), beta-carotene oxygenase 2 (BCO2), scavenger receptor class B type I (SR-BI), NPC1L1, ATP-binding cassette (ABC) transporters G5 and G8 (ABCG5 and ABCG8) genes(6 weeks)
- Taxonomic profiles of microbial communities by ribosomal RNA (16SrRNA) gene metagenomic studies. Microbiota characterization.(6 weeks)
研究者
Fernando Granado Lorencio
Principal Investigator. Chief Assistance.
Puerta de Hierro University Hospital