A Whey Protein-based Nutritional Supplement Enriched in Vitamin D, Leucine and Calcium for Patients With Parkinsonism Undergoing Rehabilitation Treatment: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Functional status - distance walked during the six minutes walking test
研究概览
简要总结
This randomized, trial will tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium would increase the efficacy of physical rehabilitation in old adults suffering from Parkinson's disease o parkinsonism
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease o parkinsonism
- •admission for physical rehabilitation
- •Informed consent
排除标准
- •Any malignant disease during the last five years
- •Known kidney failure (previous glomerular filtration rate <30 ml/min);
- •Known liver failure (Child B or C)
- •Psychiatric disease
- •Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
- •Indications related to the study product:
- •More than 10 μg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.
- •Known allergy to milk, milk products or other components of the proposed interventions
- •Indication to or ongoing artificial nutrition support
- •Inclusion in other nutrition intervention trials
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
研究组 & 干预措施
Fortifit®
Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.
干预措施: Fortifit® (Dietary Supplement)
Control group
Best local diet
干预措施: Control Group (Other)
结局指标
主要结局
Functional status - distance walked during the six minutes walking test
时间窗: 30 days
Change in the distance walked during the six minutes walking test
次要结局
- Adverse events(30 days)
- Functional status - timed up and go test(30 days)
- Self-perceived functional status(30 days)
- Functional status - Berg balance scale(30 days)
- Functional status - gait speed(30 days)
- Muscle mass(30 days)
- Treatment continuation(30 days)
- Functional status - handgrip strength(30 days)
- Body weight(30 days)
研究者
Emanuele Cereda
Co-Project Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia