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临床试验/NCT05420142
NCT05420142已完成2 期

Innovative plAnt Protein Fibre and Physical Activity Solutions to Address Poor appEtite and prevenT undernutrITion in oldEr Adults (APPETITE): Determination of In-vivo Plasma AA Appearance From Plant Protein Fibre Products

University College Dublin3 个研究点 分布在 2 个国家目标入组 9 人开始时间: 2022年3月14日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
9
试验地点
3
主要终点
Acute change in amino acid appearance in peripheral blood following a test meal ingestion

研究概览

简要总结

This study aims to assess the digestibility and efficacy of the study groups previously developed innovative plant-based protein and fibre products.

详细描述

Older people are at high risk of undernutrition, which leads to serious adverse health outcomes, but effective preventive strategies are lacking. Effective, new strategies should focus on the etiology of undernutrition and directly address potential causes and mechanisms underpinning undernutrition.

Reduced food intake and restricted dietary diversity are direct consequences of poor appetite. Recent studies have shown, that older persons with a poor appetite demonstrate lower intake of protein and dietary fibre, and of several nutrient-rich food groups (e.g. meat, fish, wholegrains, vegetables), after adjustment for energy intake and other potential confounders, but a higher consumption of food groups low in micronutrients (e.g. fats, oils, sweets, and sodas), compared to those with good appetite.

Enhancing dietary protein and fibre intake in older Europeans is a key objective because intake of both nutrients is sub- optimal, not only in those with poor appetite. Adequate protein intake prevents excessive decline in muscle mass and function (sarcopenia), a widespread health-issue in older persons, intensified by undernutrition. Adequate dietary fibre intake prevents constipation and impedes the development of many chronic diseases prevalent in older people. Thus, targeting adequate protein and fibre intake may be particularly beneficial in this vulnerable population.

A preparatory short-term study will be performed to assess in 10 healthy older adults the net peripheral Amino Acid (AA) appearance following ingestion of 3 selected Plant-based Proteins and Fibre (PPF) products previously developed by the wider study collaborators, compared to the reference of 30 g whey protein. Plasma concentrations of AA from arterialised blood will be measured by ion exchange chromatography in blood samples (1 drawn before and 6 during 3 hours postprandial). This step will allow the research group to compare in-vitro (previous work) and in-vivo digestibility of several PPF mixtures and identify the product with both optimal amino acid composition and sensory properties as well as optimal post-prandial plasma amino acid profile to be used in further studies.

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
Single (Participant)

入排标准

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

入选标准

  • Community-dwelling, Age 65+ years, not a heavy smoker (≤10/day), BMI 18-30 kg/m2

排除标准

  • Medical condition or medication known to impact appetite or energy intake, consumes more than 14 (female) or 21 (male) units of alcohol per week, inability to come to study centre, self-reported cognitive impairment or diagnosis of clinical depression, heavy smoker (>10/day)

结局指标

主要结局

Acute change in amino acid appearance in peripheral blood following a test meal ingestion

时间窗: Blood samples will be taken at baseline, and at 30, 60, 90, 120, 150, & 180 minutes following ingestion of test sample

Arterialised blood samples will be drawn from antecubital vein and centrifuged at 4˚C for 10 minutes at 4000rpm and frozen at -80˚C until analysed. Samples will be analysed using HPLC methods and expressed in μmol/L.

次要结局

  • Acute changes in appetite and desire to eat(baseline, 30, 60, 90, 120, 150, & 180 minutes following ingestion of a sample meal)
  • Sensory properties and palatability of the test meal after ingestion(Immediately following test meal ingestion (single measure))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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