The Influence of Food Matrix Delivery System on the Bioavailability of Vitamin D3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cmax of vitamin D3
研究概览
简要总结
This study investigates the influence of different food matrices on the bioavailability of vitamin D.
Although most vitamin D comes from skin synthesis in response to sun exposure, dietary intake is also important - especially during winter time where there is no endogenous production of vitamin D in Denmark. A way to maintain an adequate vitamin D status is to supplement either as tablets/droplets or as fortified food. However, there seems to be an inter-individual variation in response to supplementation.
This study aims to investigate whether this variation in absorption of vitamin D may depend on delivery system.
详细描述
BACKGROUND The current project is a part of the vitamin D fortification with enhanced bioavailability study program (acronym: DFORT) which is an interdisciplinary project including research groups from Denmark, Spain, and the Netherlands supported by the Danish Innovation Foundation. The overall aim of DFORT is to develop more efficient strategies for vitamin D fortification by studying the influence of the delivery matrix on the bioavailability of vitamin D. DFORT is organized into four scientific work packages (WP).
The first two WPs have aimed to study whether complex formation (nano-encapsulation) of vitamin D with different proteins may enhance the stability of vitamin D (WP 1 lead by prof. Daniel Otzen, AU-iNANO) and the effect of complex formation in real food systems including investigations on the stability during storage, light- and heat-exposure (WP 2 lead by associate professor Trine Kastrup Dalsgaard, AU-FOOD). WP 1+2 have shown that vitamin D can be stabilized by complex formation with whey protein and that the encapsulation may cause less oxidative degradation thereby improving the stability of vitamin D in different food systems.
In the current study (WP 3 lead by prof. Lars Rejnmark, AU-Health), the bioavailability of vitamin D in different food matrices (including complex formation with whey protein) will be studied in humans. Biological samples will be collected in WP 3 allowing for metabolomics studies on possible associations between vitamin D supplementation through different food matrices and metabolic phenotype (WP 4 lead by prof. Hanne C. Bertram, AU-FOOD).
Although most of the total body vitamin D is synthesized in the skin after exposure to UV light (wavelength of 290-315 nm), most individuals require at least some dietary vitamin D to maintain a replete vitamin D status. This is especially true during wintertime. With a latitude of 56°N in Denmark, there is no endogenous synthesis of vitamin D in the months extending from October to April, which means that the inhabitants have to rely on food sources in order to maintain a replete vitamin D status. Cholecalciferol (vitamin D3 [D3]) is the main dietary source of vitamin D, but it is only present in a limited number of food items (such as fatty fish) making it difficult to achieve the recommended intake of 10 µg D3 per day.
Vitamin D status may be improved in response to an increased intake of vitamin D in terms of either supplementation with tablets or food fortification. Numerous studies have shown increased 25-hydroxy vitamin D (25OHD) levels in response to an increased intake of vitamin D. It is generally assumed that mean 25OHD concentrations increase by 0.7 nmol/L in response to an increased long-term intake of 1 µg vitamin D per day although the relative increase per microgram supplemented may be higher if baseline levels are low. Despite this well-known dose-response relationship in groups of people, several studies have documented that the change in serum 25OHD levels in response to vitamin D supplementation varies widely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will not know if they receive juice with complex-bound vitamin D3 or not.
入排标准
- 年龄范围
- 60 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal
- •Caucasian
- •Total plasma 25-hydroxy vitamin D < 50 nmol/L
- •Understand oral and written Danish
- •Able to consent
排除标准
- •Known allergic reaction/intolerance to Vitamin D supplementation / milk products / juice
- •Known chronic kidney disease (creatinine > 90 µmol/L), previous kidney transplantation or known kidney artery stenosis
- •Known liver disease
- •Known gastrointestinal malabsorption
- •Current malignant disease
- •Hypercalcemia (ionised calcium ≥ 1.33 mmol/L)
- •Treatment with diuretics, lithium or current use of steroids
- •Current use of calcium and/or vitamin D supplementation
- •Planned travel during the intervention period to areas where sun exposure is expected
- •Use of solarium
- •Treatment with beta-blockers
- •Overt cardiovascular disease such as known severe heart failure (NYHA III-IV), previous major heart surgery, pacemaker, arrhythmias (e.g. atrial fibrillations or flutter, second- and third-degree atrioventricular block)
结局指标
主要结局
Cmax of vitamin D3
时间窗: 10 hours
Maximum observed concentration of vitamin D3
AUC of vitamin D3
时间窗: 12 hours
Area under the curve for time-concentration relationships during the absorption phase
次要结局
- Urine concentration of sodium(24 hours)
- Concentration of vitamin D metabolites(24 hours)
- Concentration of PTH(24 hours)
- Plasma concentration of ion-calcium(24 hours)
- Urine concentration of calcium(24 hours)
- Urine concentration of creatinine(24 hours)
- Urine concentration of phosphate(24 hours)
- Urine concentration of magnesium(24 hours)
- Urine concentration of potassium(24 hours)
- Urine osmolality(24 hours)
- Systolic and diastolic blood pressure(4 hours)
- Pulse wave velocity(4 hours)
- Arterial stiffness(4 hours)
