Innovative PlAnt Protein Fibre and Physical Activity Solutions to Address Poor AppEtite and PrevenT UndernutrITion in OldEr Adults (APPETITE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Ad libitum energy intake (kcal)
研究概览
简要总结
The APPETITE Trial aims to investigate the efficacy of innovative plant protein fibre (PPF) products (developed in a previous workpackage) as part of a personalised diet with/out physical activity on appetite and incidence of undernutrition in older persons from three European countries at high risk of undernutrition.
详细描述
It is normal that dietary intake decreases as we age due to reduced activity and muscle mass. However, appetite is a key determinant of dietary intake, and poor appetite can result in undernutrition. In many instances, older adults do not recognise their appetite has decreased significantly as the decline is slow and progressive. Protein and fibre are often poorly consumed in the diets of older adults with decreased appetite, but essential for health and well-being. Interventions designed to increase appetite, or increase dietary intake despite a reduced appetite, should therefore be key to preventing undernutrition (i.e. protein-energy malnutrition as well as nutrient deficiencies). However, treatment strategies for poor appetite are not well-established.
In this multi-centre randomised controlled trial conducted in Ireland, Germany, and Italy, a two-by-two factorial design will define the individual and combined impact of two intervention conditions over 12 weeks: 1) personalised diet with focus on plant-based protein plus fibre; and 2) physical activity.
At each centre, 60 older adults (180 in total) will be randomly allocated to one of the following four groups over a 12 week period: 1) personalised diet plus physical activity program (PD + PA), 2) usual diet plus physical activity (PA), 3) personalised diet and no PA (PD), and 4) control (usual diet, no PA).
Using identical procedures, two testing visits will be completed before and after the 12 intervention or control period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community-dwelling,
- •Age 65+ years,
- •BMI 19.5-30.4kg/m2,
- •Inactive (<150 minutes of moderate to vigorous physical activity per week and no regular resistance training),
- •Have proof of Covid-19 vaccination
排除标准
- •Major cognitive impairment (MMSE ≤24),
- •Uncontrolled Clinical depression (CES-D >16),
- •Medical condition or current medication known to impact appetite or energy intake,
- •Other medical condition that may impact ability to participate in study or study outcomes,
- •Heavy smoker (>10/day),
- •Plans to relocate out of the study area within the next 6 months,
- •Inability to come to study centre/PA program location,
- •Currently participating in another intervention study,
- •Inability to participate in physical activity,
- •Unable to walk across a room,
- •Allergic to or unwilling to consume any of the study test foods,
- •Loss of taste or smell associated with COVID-19,
- •Unwilling to be randomised to any intervention group.
结局指标
主要结局
Ad libitum energy intake (kcal)
时间窗: To be assessed at baseline and following a 12-week intervention or control period
12-week change in energy intake assessed at an an ad libitum lunch test meal
Changes in subjective appetite sensations
时间窗: To be assessed at baseline and following a 12-week intervention or control period
12-week change in appetite to be assessed by Visual Analogue Scale (VAS) during a test meal challenge. The VAS is a validated tool for assessing subjective sensations such as hunger, fullness and desire to eat. On each 100-mm line, an appetite (hunger, fullness, desire to eat) sensation was paired with the opposing sensation (for example, 'hungry' and 'not hungry').
次要结局
- Resting Energy Expenditure (REE) (sub-sample)(To be assessed at baseline and following a 12-week intervention or control period)
- Cardiorespiratory fitness(To be assessed at baseline and following a 12-week intervention or control period)
- Body composition (fat mass, fat free mass) by air displacement phlethysmography (sub-sample)(To be assessed at baseline and following a 12-week intervention or control period)
- Cognitive Dietary Restraint(To be assessed at baseline and following a 12-week intervention or control period)
- Dietary Record (energy, protein and fibre intake)(To be assessed at baseline and following a 12-week intervention or control period)
- Gut metabolomic profiles and gut microbiome diversity(To be assessed at baseline and following a 12-week intervention or control period)
- Body composition by Bioelectrical Impedance Analysis (BIA)(To be assessed at baseline and following a 12-week intervention or control period)
- Body weight (kg)(To be assessed at baseline and following a 12-week intervention or control period)
- Handgrip strength(To be assessed at baseline and following a 12-week intervention or control period)
- Isometric knee extension strength(To be assessed at baseline and following a 12-week intervention or control period)
- Appetite hormones (Ghrelin, GLP-1, & PYY) (sub-sample)(To be assessed at baseline and following a 12-week intervention or control period)
- Test meal palatability by Visual Analogue Scale (VAS)(To be assessed at baseline and following a 12-week intervention or control period)
- Calf circumference (cm)(To be assessed at baseline and following a 12-week intervention or control period)
- Body composition by Dual-energy X-ray absorptiometry (DXA) (sub-sample)(To be assessed at baseline and following a 12-week intervention or control period)
- 7-day physical activity score as assessed by ActivPAL v4.0(To be assessed at baseline, prior to commencing the intervention, and during week 12 of the intervention or control period)
- Physical performance(To be assessed at baseline and following a 12-week intervention or control period)
- Participants subjective rating of perceived Quality of Life as assessed by the EQ-5D-5L(To be assessed at baseline and following a 12-week intervention or control period)
- Perception and evaluation of the trial(End of trial (up to 18-weeks))
- Motor Unit Signalling (sub-sample)(To be assessed at baseline and following a 12-week intervention or control period)
- muscle signalling related to muscle plasticity, metabolism, denervation and muscle capillarization (sub-sample)(To be assessed at baseline and following a 12-week intervention or control period)
- Innate immune training of macrophages(To be assessed at baseline and following a 12-week intervention or control period)
- Blood hormone and metabolite profile(To be assessed at baseline and following a 12-week intervention or control period)
- Appetite by Simplified Nutritional Appetite Questionnaire (SNAQ)(To be assessed at baseline and following a 12-week intervention or control period)
- Standing height (cm)(To be assessed at baseline and following a 12-week intervention or control period)
- Motor Unit Number(To be assessed at baseline and following a 12-week intervention or control period)