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临床试验/NCT04207294
NCT04207294已完成不适用

Bioavailability of Vitamin D-enriched Pork and Chicken in Comparison to a Vitamin D Supplement in Healthy Adults: an Acute Study

University of Ulster1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年1月16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
入组人数
15
试验地点
1
主要终点
Change in vitamin D concentration

研究概览

简要总结

The importance of achieving an adequate vitamin D status is widely recognised, with public health and research communities heightening their interest over recent years.

Whilst vitamin D can be synthesised following skin exposure to UV light, due to public health concerns regarding sun safety, and modern indoor lifestyles, it has become evident that endogenous synthesis may not be an effective means of maintaining an adequate vitamin D status across the year. Given the marked variation in seasonally-induced cutaneous synthesis, habitually low dietary vitamin D intakes of 2-4µg/day typically reported within nationally represented population surveys, and the generally low uptake of supplementation at the population level, it is warranted to identify alternative food-based strategies to yield greater adherence to the 10µg DRV, particularly during winter months where sunlight exposure is negligible. Commodity-based biofortification may provide an innovative and viable additional food-based approach to suboptimal vitamin D status, in combination with safe sun exposure, inclusion of natural and fortified dietary sources and/or supplementation.

Meat naturally contains vitamin D3 and 25(OH)D3, yet by manipulating feeding regimes and/ or housing environments, it is possible to improve the concentration of both metabolites in animal products. Eggs, beef and pork provide viable opportunities for the enhancement of vitamin D3 and 25(OH)D3 which contribute to an increase in total vitamin D activity (vitamin D3 + [25(OH)D3 x 5]), and therefore would be expected to positively impact vitamin D status. Albeit whilst much biofortification research has been established, less is known regarding its effectiveness at raising circulating serum 25(OH)D concentrations amongst apparently healthy adults, with the exception of some plant-based foods.

Therefore, an opportunity exists to understand the bioavailability of vitamin D-enriched pork and vitamin D-enriched chicken to increase 25(OH)D concentration.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • · Free-living, apparently healthy Caucasian adults
  • Aged 18-65 years at Recruitment
  • Body Mass Index (BMI) ≥18.5 and <25kg/m2
  • If consuming vitamin D supplements, willing to discontinue 4 weeks prior and for duration of study
  • Non-smokers

排除标准

  • · Non-Caucasian adults
  • Adults <18 or >65 years at recruitment
  • Taking vitamin D supplement and not willing to discontinue vitamin D supplementation for 4 weeks prior to and for duration of study
  • Current smokers
  • Pregnant/lactating females
  • Use of tanning facilities or winter vacation planned during the intervention period to a location expected to increase cutaneous synthesis
  • Severe medical illness
  • Medications which interfere with vitamin D metabolism e.g. steroid medications (e.g. prednisone), weight loss drug orlistat (e.g. Xenical and Alli), cholesterol-lowering drug cholestyramine (e.g. Questran, LoCholest and Prevalite), seizure drugs Phenobarbital and Dilantin, anti-tuberculosis, statins or thiazide diuretics
  • Intestinal malabsorption syndrome
  • Excessive alcohol use (>14 units/ week)

研究组 & 干预措施

Vitamin D-enriched pork

Experimental

One portion of Vitamin D-enriched pork

干预措施: Pork arm (Other)

Control pork

Placebo Comparator

One portion of control pork

干预措施: Pork arm (Other)

Vitamin D-enriched chicken

Experimental

One portion of Vitamin D-enriched chicken

干预措施: Chicken arm (Other)

Vitamin D supplement

Active Comparator

Equivocal dose of Vitamin D supplement

干预措施: Pork arm (Other)

Control chicken

Placebo Comparator

One portion of control chicken

干预措施: Chicken arm (Other)

结局指标

主要结局

Change in vitamin D concentration

时间窗: Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)

Vitamin D3, vitamin D2, 25(OH)D3, 25(OH)D2) (nmol/L) in serum/plasma

次要结局

  • Calcium serum concentrations(Monitored over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour))
  • Parathyroid hormone (PTH) concentration(Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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