跳至主要内容
临床试验/NCT06384690
NCT06384690进行中(未招募)不适用

Large-Scale, Sustainable, Nutrient-Dense MicroVeg: Generating Health Evidence & Production Capacity to Support Incorporation Into UK Diet

University of Exeter2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
32
试验地点
2
主要终点
Tandem Mass Tag (TMT) global proteomics

研究概览

简要总结

Micro-vegetables (MV) are seedlings of larger vegetables. They can be grown quickly and are a concentrated source of micronutrients. MV are thought to have broad health benefits, including many inflammatory conditions. These include metabolic, cardiovascular, and cognitive diseases. This could have important implications for the health of an ageing UK population. Less than a third of British adults consume 5 portions of fruit and vegetables per day; this is the level that reduces risk of morbidity and mortality. Vegetables, including MV may - at least in part - exert their health effects by changing the level and type of bacteria in the mouth and gut. Despite their promise, the MV scientific literature is not yet extensive enough to support definitive health claims. It requires the addition of high-quality studies that are relevant to humans. This study will firstly investigate the anti-inflammatory effects on skeletal muscle and adipose tissue in older adults, using a proteomics approach. Second, this study will assess concentrations of circulating inflammatory markers in the sera collected from participants at baseline and at the conclusion of a 6-week period. Further, this study will describe the effects of six weeks MV consumption on cognition, and the oral and gut microbiome. As the bioactive compounds in the MV are owed to the potential beneficial effects for human health, these will be characterised in sera collected from participants.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 60 years and above
  • Body mass index > 25kg/m2
  • Able to give written informed consent to participate in the study

排除标准

  • Not meeting any inclusion criteria
  • Have had an adverse reaction to a local anaesthetic in the past
  • Hepatitis B, Hepatitis C or HIV positive
  • Have a bleeding disorder or are regularly taking a medication that will impair their blood's capacity to clot (e.g., aspirin, clopidogrel, warfarin, heparin)
  • Have had a severe adverse reaction to plasters
  • Have a gastrointestinal disorder that may impair the absorption of the supplement from the gastrointestinal tract
  • Have an autoimmune condition
  • Have a diagnosed neurocognitive disorder
  • Have a skin condition that is likely to increase the risk of infection at the biopsy site
  • Frequent use of medication or recreational drugs likely to affect our results
  • Recent infection or vaccination
  • Known allergy to any vegetables
  • Participated in a nutrition supplementation study in the last month

结局指标

主要结局

Tandem Mass Tag (TMT) global proteomics

时间窗: Adipose and skeletal muscle sampling at baseline and 6-week post-intervention

Characterisation of the proteome - hypothesis free

次要结局

  • Concentration of circulating bioactive components(Blood sample collected at baseline and 6-week post-intervention)
  • Microbiome(Faecal and saliva collected at baseline and 6-week post-intervention)
  • Concentration of broad panel of inflammatory cytokines(Blood sample collected at baseline and 6-week post-intervention)
  • Simple Reaction Time(5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8))
  • Digit Vigilance(5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8))
  • Choice Reaction Time(5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8))
  • Pattern Separation(5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Generating Health Evidence From Dietary... | 临床试验