A Randomised Controlled Trial to Evaluate the Effect of a Protein Enriched Mediterranean Diet and Exercise Intervention on the Nutritional Status and Cognitive Performance of Adults At Risk of Undernutrition and Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Mini Nutritional Assessment Score- Long Form
研究概览
简要总结
PROMED-EX is a single-blind, parallel group randomised controlled trial to determine the effect of a PROtein enriched MEDiterranean diet (PROMED) in comparison to a PROtein enriched MEDiterranean diet and EXercise (PROMED-EX) intervention, or standard care on the nutritional status and cognitive performance of older undernourished adults with subjective cognitive decline.
详细描述
Undernutrition is common in older adults and can cause significant negative impacts on the health of older people, leading to weight loss and decline in cognitive function (memory and thinking abilities), loss of independence and hospitalisation. Undernutrition is associated with £23.5 billion/year in health and social care costs in the United Kingdom - over half of these costs are related to undernutrition in older adults.
Research suggests that undernutrition and weight loss occur a long time (at least 10 years) before the symptoms of cognitive decline become apparent. This means that correcting undernutrition and weight loss could help to prevent the onset of cognitive impairment.
The aim of the PROMED-EX trial is to test the effect of a 6-month protein enriched Mediterranean diet, with and without exercise, on the risk of undernutrition and cognitive decline in older adults in Northern Ireland. The PROMED-EX trial will recruit 105 older adults living in the community, at risk of poor nutrition, with a decline in memory but without a diagnosed cognitive impairment. Investigators will collect several measurements to determine the nutritional status and cognitive functioning of study participants and will repeat measurements during the study (at the start of the study, at 3 months (study midpoint) and at 6 months (study endpoint).
The goal is to identify potential effective solutions to undernutrition which can reduce cognitive decline and other negative health impacts on older adults. The research can be used to guide public health dietary guidelines for older people to prevent undernutrition and increase healthy life years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Sealed opaque envelopes have been prepared by a member of the research team (independent of data collection). Envelops numbered with study IDs will conceal the allocated group assignment from the research team involved in screening and recruitment. Participants will be allocated a study ID number at baseline once written consent to participate has been provided. After completion of baseline measurements, a researcher (independent of outcome measurements) will open the sealed envelope corresponding to the participant's study ID to reveal the allocated group and arrange intervention delivery if required.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community-dwelling (non-institutionalised) participants ≥60 years older
- •A high risk of undernutrition as defined by a Mini Nutritional Assessment -Short Form (MNA-SF) score of 8 - 11
- •Positive screen for Subjective Cognitive Decline (SCD)
排除标准
- •Cognitive impairment determined by the Mini Mental State Assessment (MMSE) or Telephone Cognitive Screen (T-CogS)
- •Receiving oral or artificial nutritional support or medical food supplements
- •Taking high dose nutritional supplements (supplements above the Reference Nutrient Intake levels).
- •Dietary restrictions/allergies that limit ability to adhere to study requirements
- •A diagnosis of mild cognitive impairment or dementia
- •Dysphagia
- •Chronic kidney disease
- •Poorly controlled diabetes (HbA1c >8% or diabetes complications)
- •Severe visual or language impairment
- •Self-reported psychiatric problems or significant medical co-morbidities that compromise the ability to take part/limit capacity to consent
- •Diagnosis of a comorbid condition that may alter performance on cognitive tests, e.g. stroke, head injury, Parkinson's disease, learning disabilities.
结局指标
主要结局
Mini Nutritional Assessment Score- Long Form
时间窗: Baseline and 6 months
The Primary outcome is change at 6 months (study endpoint) in Mini Nutritional Assessment (MNA) score between the two intervention groups and the control group. The MNA is a well validated tool with good sensitivity and specificity for predicting nutritional risk in older community dwelling adults. Scores range from 0-30 with a lower score reflecting poorer nutritional status.
次要结局
- Body Water (%)(Baseline, 3 months and 6 months)
- Weight (kg) and height (cm)(Baseline, 3 months and 6 months)
- Nutrient intake: PROMED Mediterranean Diet Score(Baseline, 3 months and 6 months)
- Nutrient intake: (4 day food diary)(Baseline, 3 months and 6 months)
- Simplified Nutrition Appetite Questionnaire (SNAQ)(Baseline, 3 months and 6 months)
- Waist circumference (cm)(Baseline, 3 months and 6 months)
- Diastolic Blood Pressure (mmHg)(Baseline, 3 months and 6 months)
- Biochemical markers: nutritional, cardiometabolic and inflammatory(Baseline, 3 months and 6 months)
- Mini Nutritional Assessment Score (midpoint change)(Baseline and 3 months)
- Physical Activity determined by completion of a Recent Physical Activity Questionnaire(Baseline, 3 months and 6 months)
- Delayed recall test (0-10)(Baseline, 3 months and 6 months)
- Total Body Fat (%)(Baseline, 3 months and 6 months)
- Lean Muscle Mass (kg)(Baseline, 3 months and 6 months)
- Capturing Changes in Cognition (Catch-Cog)(Baseline, 3 months and 6 months)
- Trail Making Tests (TMT) (Part A & B)(Baseline, 3 months and 6 months)
- Functional performance measured using the Short Physical Performance Battery (SPPB) test.(Baseline, 3 months and 6 months)
- Grip Strength measured by isometric grip force (0-100kg)(Baseline, 3 months and 6 months)
- Health-related quality of life (Short Form (SF)-36)(Baseline, 3 months and 6 months)
- Geriatric Depression Scale(Baseline, 3 months and 6 months)
- Systolic Blood Pressure (mmHg)(Baseline, 3 months and 6 months)
研究者
Claire McEvoy
PROMED-EX Principal Investigator
Queen's University, Belfast