NCT03713463终止不适用
An Observational, Multicenter Study to Evaluate the Benefits of Regular Intake of Standard ONS in Indian Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 45
- 主要终点
- Weight
研究概览
简要总结
This is a prospective, single arm, baseline-controlled multicenter study to observe benefits on Oral Nutritional Supplement (ONS) intake in adults with medical conditions associated with poor nutritional status.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory adult patients >or equal to 45 years of age
- •Patients at the risk of malnutrition (MST > or equal to 2)
- •Patients who understand nature of the study, willing to participate in all scheduled visits and trial procedures & provide a written informed consent.
排除标准
- •Subject using commercially available macronutrient food supplements or another ONS
- •History or evidence of hypersensitivity to any component of study product
- •History of any Gastrointestinal disorder/surgery that affects digestion and/or absorption of food
- •Evidence of active TB, Hepatitis B, Hepatitis C or HIV infection, type 1 or type 2 diabetes mellitus, malignancy and any other disease affecting appetite and weight loss
- •History or evidence of any medical condition that in the opinion of Investigator can interfere with the study assessment of outcome or Patients with scheduled surgery during the duration of the study
- •Subjects who are unlikely to comply with the study protocol or follow up regularly for study assessments
- •Pregnant or lactating women
结局指标
主要结局
Weight
时间窗: Baseline to 12 weeks
Measured weight kg
次要结局
- Hand Grip(Baseline to 12 weeks)
- Quality of Life (QoL)(Baseline to 12 weeks)
研究者
研究点 (45)
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