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临床试验/NCT02758795
NCT02758795已完成不适用

Antiinflammatory Effect of Dietary Protein Intake in Elderly People

University of Limerick1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Interleukin 6 (IL-6) response of macrophage cells to stimulation with bacterial lipopolysaccharide (LPS)

研究概览

简要总结

The aim is to evaluate the effect of ingestion of a modified bovine milk protein on circulating markers of inflammation in healthy men and women aged 50-70y.The focus is healthy ageing, i.e. delaying the deterioration in health status in older adults. Loss of lean tissue mass, termed sarcopenia is a consequence of aging per se, modified by nutrition and lifestyle behaviour. Advancing the prospect of 'successful aging' a 6-month period of protein-based nutritional support has shown preservation/accrual of lean tissue. Chronic low-grade inflammation is common in ageing and is a compounding factor leading to 'anabolic blunting', i.e. a reduced sensitivity of lean tissue to enhance the synthesis of lean tissue mass in response to protein feeding. Using a simulated human gastrointestinal digestion model we have recently shown proteins to have an anti-inflammatory bioactivity in vitro. This study investigates whether the anti-inflammatory response is retained, post-digestion in vivo.

详细描述

Participants to be recruited, are aged 50 to 70y from the Healthy Aging Study (EHSREC10_45) who will attend on 4 test days (occasions)

Study Design: Single blind, randomised, repeated measures design with 2 independent factor (time x treatment)

Procedures:

Occasion 1 Subjects will undertake a preliminary assessment as per EHSREC 10_45 as follows; i. medical history and examination by a qualified medical doctor (~45 min); ii. provide a blood and urine sample to be evaluated (following analysis) by a qualified medical doctor;

Occasion 2 Subjects will then undertake, as per EHSREC 2013 01_12, an assessment of body composition, dietary intake and habitual physical activity as follows; iii. habitual food intake evaluated by a qualified dietitian (~45 min); iv. body composition (~45 min) v. habitual physical activity level (PAL) quantified using the European Physical Activity Questionnaire (EPAQ-2; ~ 15 min).

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
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and Women
  • Aged 50 to 70y
  • Conducted by a medical doctor and based on Grieg et al. 1994 to be 'healthy' (i.e. 'disease-free') free-living and fully mobile

排除标准

  • Age <50 or > 70y.
  • Contraindication identified by medical doctor based on Grieg et al. 1994 definition of 'healthy' (i.e. 'disease-free') free-living and fully mobile older subjects
  • Lactose intolerant or intolerance to dairy-based foods.

结局指标

主要结局

Interleukin 6 (IL-6) response of macrophage cells to stimulation with bacterial lipopolysaccharide (LPS)

时间窗: All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinks

Macrophages seeded at a density of 0.2 x 10\^5 cells/ml, stimulated with LPS (0.1ug/ml) and incubated for 24h in serum obtained from subjects reported as %of control value, i.e. relative to cells incubated without human serum

Interleukin-1 beta (IL1_beta) response of macrophage cells to stimulation with bacterial lipopolysaccharide (LPS)

时间窗: All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinks

Macrophages seeded at a density of 2 x 10\^5 cells/ml, stimulated with LPS (0.2ug/ml) and incubated for 24h in serum obtained from subjects reported as %of control value, i.e. relative to cells incubated without human serum

Tumour necrosis factor alpha (TNF-alpha) response of macrophage cells to stimulation with bacterial lipopolysaccharide (LPS)

时间窗: All timepoints to 180 min following ingestion of NUTRIENT and CONTROL drinks

Macrophages seeded at a density of 0.2 x 10\^5 cells/ml, stimulated with LPS (0.1ug/ml) and incubated for 24h in serum obtained from subjects reported as %of control value, i.e. relative to cells incubated without human serum

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Phil Jakeman

Professor

University of Limerick

研究点 (1)

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