NCT01483976已完成3 期
Comparison of Medical Nutritional Supplements With or Without AN777 in Elderly Men
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in protein metabolism
研究概览
简要总结
The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male and is ≥ 60 and ≤ 90 years of age.
- •Body Mass Index (BMI) > 20.0, but < 35.
- •Ability to climb a flight of 10 stairs or walk an equivalent of city block without help within the 3 months prior to enrollment.
- •Refrain from taking any dose of NSAIDs or acetaminophen on the day of and 24 hours prior to Visit 2 and Visit
- •Refrain from using any pulmonary maintenance medications on the days of Visit 2 and Visit
- •Refrain from intense physical activity between visits.
排除标准
- •Systemic corticosteroids within the 3 months prior to enrollment.
- •Blood thinner or anticoagulant medication within 1 week prior to enrollment.
- •Glomerular filtration rate (eGFR) of < 40 mL/min/1.73m
- •Antibiotics within 1 week prior to enrollment.
- •Major surgery less than 3 months prior to enrollment in the study.
- •Active malignant disease or treated within the last 6 months for cancer.
- •Immunodeficiency disorder.
- •Myocardial infarction 3 months prior to enrollment.
- •Chronic obstructive pulmonary disease
- •History of allergy to any of the ingredients in the study products.
- •Conditions precluding ingestion or absorption of the study product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease.
- •Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition.
- •Pursuing weight loss or weight gain.
- •Medications/dietary supplements/substances that could modulate metabolism or weight.
结局指标
主要结局
Change in protein metabolism
时间窗: Between baseline and 8 hours later
Via amino acid tracers
次要结局
- Intracellular signaling pathway metabolism(Between Baseline and 8 hours later)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effect of Oral Nutritional Supplements to Older Patients Discharged With a Rehabilitation PlanNutritional RiskRehabilitationOral Nutritional SupplementsNCT05556876Herlev and Gentofte Hospital123
已完成
2 期
Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis PatientsEnd Stage Renal DiseaseNCT00244075Vanderbilt University46
已完成
不适用
Effects of Nutritional Supplementation (Product 4808) on Acute Skeletal Muscle Protein Synthesis in Cancer PatientsCancerNCT00446888University of Arkansas35
已完成
3 期
Supplemental Enteral Protein in Critical IllnessNutrition DisorderTraumaCritical IllnessNCT03170401University of Washington500
已完成
不适用
Oral Protein Supplements for Nutritional and Quality of Life Improvement After Pancreatic Resection in Elderly PatientsIntraductal Papillary Mucinous NeoplasmPancreatic CancerSolid Pseudopapillary TumorCholangiocarcinomaNeuroendocrine TumorNCT06570174Yonsei University60