A Whey Protein-based Nutritional Supplement Enriched in Vitamin D, Leucine and Calcium for Sarcopenia in Older Adults Undergoing Physical Rehabilitation the IRIS (Improving Rehabilitation In Sarcopenia) Study: a Randomized, Double-blind, Placebo-controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Gait speed
研究概览
简要总结
This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia
详细描述
This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 65 years or older
- •admission for physical rehabilitation
- •sarcopenia, measured with bioelectrical impedance assessment (BIA) + handgrip strength and gait speed
- •Mini Mental State Examination ≥18
- •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
Experimental Product
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: Experimental product (Dietary Supplement)
Isocaloric Placebo
Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.
干预措施: Isocaloric placebo (Dietary Supplement)
结局指标
主要结局
Gait speed
时间窗: 8 weeks
Change in gait speed (4-meter walking test)/month
次要结局
- Functional status - ADL(8 weeks)
- Functional status - handgrip strength(8 weeks)
- Costs(8 weeks)
- Physical performance - Timed Up and Go test(8 weeks)
- Functional status - Barthel(8 weeks)
- Body weight(8 weeks)
- Muscle mass(8 weeks)
- Cognitive function - trail making test(8 weeks)
- Physical performance - Tinetti(8 weeks)
- Physical performance - chair-stand(8 weeks)
- Quality of life(8 weeks)
- Cognitive function - Mini Mental State Examination(8 weeks)
- Adverse events(8 weeks)
研究者
Mariangela Rondanelli
Principal Investigator
Azienda di Servizi alla Persona di Pavia