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临床试验/NCT03219853
NCT03219853Unknown不适用

Investigating Flavour-nutrient Learning in Humans Using Selenium-enriched Parsnips

Newcastle University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
52
试验地点
2
主要终点
Food sensory perception

研究概览

简要总结

Study aims to investigate 2 topics:

  1. Flavour-Nutrient Learning (FNL) FNL proposes that personal food preferences may be influenced by unconscious mechanisms which operate to ensure the safeguarding of individual nutrient levels. The theory postulates that food preferences may change over time to address changing nutritional status (Yeomans, 2012).

This study aims to explore FNL in humans by investigating the preferences of participants with low and high blood-selenium levels in relation to selenium-enriched parsnips. Participants will be investigated in a two-week trial in which they will undertake two food sensory tests: one before, and one after, the two-week period where they will incorporate provided parsnips into their diet.

Some provided parsnips will contain higher levels of selenium than others, neither the participants nor the lead researcher will know which type of parsnip each participant receives.

It is hypothesised that the second food sensory test, performed after the intervention period, will show that participants of lower initial blood-selenium levels will demonstrate an increased liking for the selenium-enriched parsnips. This may demonstrate possible FNL in humans. 2. Relationship between selenium intake & plasma selenium-status. This study will also examine the relationship (if any) between the selenium intake of all participants via the different types of parsnips, and their individual blood-selenium levels.

This will be assessed via blood tests before, during and after the trial in order to observe the blood-selenium levels of each participant.

It is hypothesised that the blood-selenium levels of participants of lower initial selenium readings will be the most improved upon consumption of selenium-enriched parsnips.

详细描述

  1. FNL Despite a wealth of animal studies (Amanoel et al, 2016; Bach et al, 2012), human FNL research is in relative infancy.

This study intends to investigate FNL in humans by exploring preferences of participants of different selenium-status regarding selenium-enriched parsnips, with non-enriched parsnips and other root vegetables to be used as comparators.

Participants will be assessed by means of food sensory tests and blood analysis before, during and after the trial period.

The trial aims to recruit 26 lower selenium-status participants of initial selenium-status approx. 70μg/L, and 26 higher selenium-status participants of initial selenium-status approx. 100μg/L (n=52). (Initial screening sample approx. n=120.) On initial screening, potential participants recording a selenium-status of under 28μg/L or over 400μg/L will be excluded (and their GP informed) for safety reasons.

Re parsnips:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Adults of either gender, aged over 18 years.
  • Willingness and ability to provide blood samples, consume parsnips daily for 2 weeks, and carry out 2 sensory tests, as described in the Participant Information Sheet.
  • Generally healthy, meaning that if health issues such as hypertension, diabetes, arthritis etc. are present, they are well controlled by appropriate treatments.

排除标准

  • Under 18 years.
  • Difficulties with chewing or swallowing.
  • Taste disorders.
  • Allergies to parsnips.
  • Impairments which may prevent mental understanding of trial, or informed consent from being given.
  • Taking supplements providing more than 60µg Se per day
  • Initial analysed selenium status of less than 28μg/L.
  • Initial analysed selenium status of over 400μg/L.
  • Any other condition that in the view of the participant's General Practitioner (GP) may make the participant unsuitable for the trial.

研究组 & 干预措施

Lower selenium-status

Experimental

干预措施: selenium enriched parsnips (Dietary Supplement)

Lower selenium-status

Experimental

干预措施: Conventional parsnips (Dietary Supplement)

higher selenium

Experimental

干预措施: selenium enriched parsnips (Dietary Supplement)

higher selenium

Experimental

干预措施: Conventional parsnips (Dietary Supplement)

结局指标

主要结局

Food sensory perception

时间窗: Baseline & post 14 weeks supplementation

change from baseline sensory perception of food samples

次要结局

  • Selenium status(Baseline, post 7 days supplementation ad post 14 days supplementation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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