A Controlled, Open-label, Parallel-group, Randomized Study to Evaluate the Effects of Additional Oral Nutritional Supplement With β-hydroxy-β-methylbutyrate on Thigh Muscle Mass in Older People With Pre-frail Status in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- lean body mass
研究概览
简要总结
Primary objective:
To evaluate the effects of additional oral nutritional supplement containing β-hydroxy-β-methylbutyrate (HMB) on thigh muscle mass in elderly subjects with pre-frail status
Secondary objectives:
- To evaluate the effects of additional oral nutritional supplement containing β-hydroxy-β-methylbutyrate on physical performance, nutrition status, and quality of life in elderly subjects with pre-frail status
- To determine the safety profile of additional oral nutritional supplement containing β-hydroxy-β-methylbutyrate in elderly subjects with pre-frail status
详细描述
This is a controlled, open-label, parallel-group, randomized, investigator initiated study to evaluate the effectiveness of oral nutritional supplement containing β-hydroxy-β-methylbutyrate (Ensure® Plus Advance) on thigh muscle mass and physical performance in elderly subjects with pre-frail status. The study is planned to enroll a total of 70 elderly subjects with pre-frail status defined by Fried's criteria with modified cutoff values as suggested by Asian Working Group for Sarcopenia (AWGS) for Asian population. The subject to be enrolled will meet the phenotypic definition of pre-frail for one or two of five phenotypic criteria: weakness as measured by grip strength, slow walking speed, low level of physical activity, self-reported exhaustion, and unintentional weight loss.
After obtaining informed consent and the confirmation of eligibility, subjects will be randomized into the HMB or control group in a 1:1 ratio. All enrolled subjects will be under standard care, which is mainly dietary consultation for healthy aging by dietitians to assure sufficient dietary protein intake in all subjects. Subjects assigned to the HMB group will consume 2 bottles of Ensure® Plus Advance per day for 12 weeks additionally, while subjects assigned to the control group will not receive any placebo or active control.
In this study, subjects will be requested for a total of 4 visits at the clinical site, including screening visit, Visit 1 for randomization, Visit 2 at Week 6, and Visit 3 at Week 12 (end of study/EOS). The telephone visit will be scheduled at Week 3 and Week 9 to follow-up with subjects.
Thigh muscle mass of all subjects will be evaluated by MRI. The physical performance of subjects will be determined by short physical performance battery (SPPB) and handgrip strength. The nutrition status of subjects will be measured by MNA® -SF and nutrition biomarkers, including serum albumin, pre-albumin, 25-hydroxy-vitamin D, vitamin B12, and C-reactive protein (CRP). SF-36v2™ Health Survey will be used to evaluate the quality of life of subjects. The safety profile of Ensure® Plus Advance will be determined by monitoring the adverse event (AE/SAE) during the study period. Blood samples of each subject will be collected at Visits 1, 2 and 3 for analysis of nutrition biomarkers. There will be a total of approximately 30 mL of blood to be collected from each subject during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects have to meet ALL inclusion criteria to be eligible for participation in the study.
- •Male or female subject with age between 65-80 years old (inclusive)
- •Subject with pre-frail status, which is defined by Fried's criteria
- •Subject who can fully communicate, understand the study, and provide the informed consent
排除标准
- •Subjects who meet ANY of the following exclusion criteria will be excluded from the study.
- •Subject with BMI > 35 kg/m2
- •Subject with active diseases judged by the investigator as below
- •Recent stroke (within 6 months prior to screening)
- •Parkinsonism
- •Motor neuron disease
- •Uncontrolled cardiovascular disease
- •Uncontrolled chronic obstructive pulmonary disease
- •Chronic kidney disease severe than Stage IIIb
- •Dementia or other mental illness with cognitive impairment
- •Uncontrolled depression
- •Chronic and acute infection
- •Uncontrolled metabolic diseases including type II diabetes mellitus
- •Thyroid disease, including hypothyroidism and hyperthyroidism
- •Uncontrolled gastrointestinal disease (inflammatory bowel disease, Crohn's disease, etc)
- •Subject with a history or evidence of malignancy in the past 5 years (except for non-melanoma skin neoplasia)
- •Subject using any dietary supplementation containing β-hydroxy-β-methylbutyrate within 1 month prior to screening
- •Subject using Ensure® plus Advance within 1 month prior to screening
结局指标
主要结局
lean body mass
时间窗: 3 months
Thigh muscle mass (kg) will be measured by MRI and be further analyzed at Visits 1 and 3 (EOS/ET). The data assessed at Visit 1 will be the baseline. The summary results of thigh muscle mass (kg) at the baseline and subsequent visits, and the change from baseline will be summarized descriptively by groups. Changes from baseline within each group will be tested by paired t-test or Wilcoxon signed-rank test with a significance level of 0.05. The change from baseline between groups will be analyzed by two sample t-test or Wilcoxon rank-sum test.
次要结局
未报告次要终点