Nutritional Supplementation in the Elderly With Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Body Composition
研究概览
简要总结
Many elderly experience weight loss and weakness with normal aging. Although there is extensive literature regarding nutritional advice for the elderly, there are few well- designed studies evaluating the effect of oral nutrition supplements in patients with weight loss and aging. The aim of this study is to examine the effect of dietary prescription with or without nutrition supplementation that includes soy protein, whey protein and fish oil in elderly patients who have suffered unintentional weight loss.
详细描述
This is an 8-week, randomized, pilot study with elderly subjects (age 65 and older) with recent unintentional weight loss who will receive either two servings of supplement powder and fish oil or no dietary supplementation (N=10 for each group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female age 65 and older
- •Non-smokers
- •Weight loss >3% body weight over 6-12 months
- •Living independently or in an assisted living facility
排除标准
- •Medical conditions that would lead to weight loss
- •Active cancer undergoing treatment (chemotherapy, radiation therapy, or planned surgical intervention)
- •CKD stage IV-V (eGFR <30) based on medical records within the last 12 months
- •Presence of dysphagia or odynophagia
- •Actively taking blood thinner such as Warfarin
- •Known history of cirrhosis with presence of ascites
- •History of a surgical procedure for weight loss (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, lap-band)
- •Any abnormal lab findings outside of normal limits as determined by the investigator
- •Dietary conditions
- •Diet restrictions including vegetarianism, veganism, soy-free diet,
- •Fish and/or fish oil allergy or intolerance
- •Milk allergy excluding lactose intolerance
- •Follows a kosher diet
- •Medications
- •Use of appetite stimulants (including megestrol, dronabinol and cyproheptadine).
- •Does not include medications used for depression (e.g. mirtazapine, paxil) if patient has been on a stable dose of this medication for at least 3 months prior to the start of this study
- •If participant is already taking a fish oil supplement, he/she must be willing to either stop the supplement or take the supplement the investigators are using in the study depending on the randomization assignment
- •Additional
- •Patient has implantable device such as a pacemaker or ICD
- •Unable to complete 6-minute walk test at baseline
- •Hospitalization within the last 30 days
- •Participation in a therapeutic research study within 30 days of baseline
- •Living in a skilled nursing facility or long-term care facility
- •Any other medical condition that principal investigator or co-investigators deem would preclude the patient from study participation
结局指标
主要结局
Body Composition
时间窗: 8 weeks
To assess if body composition is altered with increased protein supplementation using bioelectrical impedance body composition analysis to provide weight in pounds.
Nutritional Status
时间窗: 8 weeks
To assess if increased protein supplementation and fish oil has impact on nutrition status using Mini Nutritional Assessment questionnaire (minimum value 0, maximum value 14), where higher scores correlate to better nutritional status and lower scores indicate malnutrition.
Functional Improvements
时间窗: 8 weeks
To determine if protein supplementation improves functional movement using hand grip strength test as well as 6-minute walk test.
次要结局
未报告次要终点
研究者
Zhaoping Li
Chief / Professor of Medicine
University of California, Los Angeles