Sustainable Eating Pattern to Limit Malnutrition in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 主要终点
- Change in nutritional status pre- and post- intervention between experimental and control group measuring weight
研究概览
简要总结
The SENIOR STUDY is aimed at improving the condition of older adults and malnutrition management in and out Italian hospital settings, since malnutrition is highly prevalent, clinically relevant and potentially treatable conditions. This study consist of two phases: an initial cross-sectional phase and a secondary nutritional intervention phase (RCT).
The SENIOR RCT aim to evaluate the efficacy of a 6 months nutrition protocol intervention compared to hospital standard care on malnourished older adults. Physical and nutritional status will be evaluated through anthropometric measures, blood exams and physical performance. In addition, the individual health perception will be evaluated.
It is expected to find an improvements of the physical and nutritional status.
详细描述
The SENIOR RCT is a multicenter study conducted in two North Italian Scientific Hospitalization and Treatment Institution in Pavia on older malnourished adults (≥ 65 years old). The estimated duration is 24 months, which include 6 months of nutritional intervention and a follow-up after 6 months, with an preferred starting date on January 2024.
The primary objective of the SENIOR RCT is the evaluation of the efficacy of a 6 months sustainable nutrition protocol on malnourished older adults participants (diagnosed with the most recent GLIM criteria) in comparison to the hospital standard of care.
Therefore, the primary endpoint is the improvement of the nutritional status between pre- and post-intervention between experimental and control group measuring the change of body weight and strength (handgrip).
Secondary objectives are the change pre- and post-intervention between experimental and control group for blood biomarkers, dietary habits, quality of life and evaluation of sarcopenia.
Secondary endpoints are the change pre- and post-intervention between experimental and control group for blood biomarkers, MEDI-LITE score, SF-12, diet composition, phase angle and gait speed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years old
- •Admission to two Scientific Hospitalization and Treatment Institutions in Pavia, Italy
- •Informed consent written and signed
- •Malnutrition (GLIM diagnosis)
排除标准
- •Dysphagia
- •Prior nutritional medical treatment
- •Terminal disease
- •History of gastric bypass, anorexia nervosa, liver failure
- •Dementia or severe confusion (MMSE score<24/30)
- •Patients with tumor diagnosis not in remission and currently not treated with oncological therapy
- •Patients with chronic or acute respiratory failure
- •Barthel index score < 70/100
研究组 & 干预措施
Nutritional intervention
Nutritional intervention consist in a macro- and micronutrients balanced nutritional protocol with a focus on sustainability and personalized according to the individual malnutrition severity. In particular, an adequate coverage of energy, protein and water requirements will be guaranteed according to Italian reference values (LARN) and European (ESPEN) guidelines.
In light of the scientific literature and the principal issues founding in malnourished older people, the proposed nutritional protocol will provide an adequate and sustainable consumption of animal and vegetable proteins and an appropriate water intake.
The nutritional intervention will be carried out by a qualified staff.
干预措施: Nutrition intervention (dietary protocol) (Other)
Control
The control group receive the standard of care provided for malnutrition treatment by hospitals
干预措施: Hospital standard of care (Other)
结局指标
主要结局
Change in nutritional status pre- and post- intervention between experimental and control group measuring weight
时间窗: 24 months (baseline, 3 months, 6 months and 12 months)
Weight gain= + 2kg
Change in nutritional status pre- and post- intervention between experimental and control group measuring strength
时间窗: 24 months (baseline, 3 months, 6 months and 12 months)
Increase in strength = + 1 kg
次要结局
- Changes pre- and post- intervention between experimental and control groups for blood creatin Kinase(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for glycemia.(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood insulin(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood homocysteine(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for complete blood count(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood cytokine(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood sodium (Na)(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood C reactive Protein (CRP)(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood vitamine D(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood vitamine B9(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood magnesium (Mg)(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for adherence to Mediterranean Diet(24 months (baseline, 6 months and 12 months))
- Changes pre- and post- intervention between experimental and control groups for blood transaminases(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood vitamine B12(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood potassium (K)(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood calcium (Ca)(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood iron (Fe)(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups of fat free mass(24 months (baseline, 6 months and 12 months))
- Changes pre- and post- intervention between experimental and control groups for blood lipid profile(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for blood prealbumin(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for the dietary nutritional composition(24 months (baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months))
- Changes pre- and post- intervention between experimental and control groups for blood zinc (Zn)(24 months (baseline and 6 months))
- Changes pre- and post- intervention between experimental and control groups for the quality of life(24 months (baseline, 6 months and 12 months))
- Changes pre- and post- intervention between experimental and control groups in locomotion test(24 months (baseline, 6 months and 12 months))
研究者
Hellas Cena
Pro-Rector for Third Mission; Professor of Dietetics and Clinical Nutrition; Human Nutrition Researcher and Head of the Clinical Nutrition Laboratory
University of Pavia