A Pilot Study Comparing Effects of Nutrients Supplements and Dietary Approach in Frailty Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Changed dietary intake
研究概览
简要总结
The proportion of the elderly population has increased rapidly worldwide. Frailty is a common geriatric syndrome. Comprehensive dietary management strategy may have beneficial effects on frailty prevention and reversal. We compared the effects between micronutrients and/or protein supplement, and balanced diet on frailty status in elderly individuals who were at either pre-frail or frail stage. A total of 37 subjects completed a 3-month paralleled, single-blind, randomized control trial on (1) multiple nutrients supplementations, (2) multiple nutrients plus isolated soy protein supplementation, and (3) individualized nutrition education with designed dishware for balanced diet as well as food supplementations (mixed nuts and milk powder). Intervention effects on dietary intakes, biomarkers, frailty score and geriatric depression score (GDS) were assessed. The nutrition education intervention with designed dishware and milk powder/nuts supplement significantly increased the intake of vegetables, dairy, and nuts, along with increased concentration of urinary urea nitrogen of the pre-frail/frail elders. It yielded a significant reduction in frailty score (p<0.05) and a borderline decrease (p=0.063) in GDS-SF. Our study indicated that the dietary approach with easy-to-comprehend dishware and food supplements to optimize the distribution of multiple dietary components showed its potential to improve not only frail status but also psychological condition in elderly.
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
- Single (Care Provider)
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
- •≥ 65 years of age
- •Have at least one of the modified Fried's Frailty phenotypes
- •Sign informed consent form for study participation
- •Modified Fried's Frailty phenotypes:
- •unintentional weight loss > 5% or 3 kg in previous year
- •Exhaustion: defined as positive answer to the question "I had felt fatigue or exhaustion for >3 days in the previous week"
- •Weakness: hand grip strength is below the gender and BMI specific thresholds. The cutoff points are set as follows:
- •Men: For BMI ≤ 22.1, < 25.0 kg; for BMI 22.1-24.3, < 26.5 kg; for BMI 24.4-26.3, < 26.4 kg; for BMI ≥ 26.3, < 27.2 kg Women: for BMI ≤ 22.3, <14.6 kg; for BMI 22.3-24.2, <16.1 kg; for BMI 24.3-26.8, <16.5 kg; for BMI ≥ 26.8, < 16.4 kg
- •Slowness: gait speed is slower than the gender and height specific thresholds. The cutoff points are set as follows:
- •Men: for height ≤ 163 cm, >14.92 sec/10m; for > 163 cm, >=14.08 sec/10m Women: for height ≤ 152 cm, >17.54 sec/10m; for > 152 cm, >=14.92 sec/10m
- •Low Physical Activity: No exercise and no labor or leisure-time physical activity in the past year, or below the calorie consumption: men <594kcal/week and women <295kcal/week.
排除标准
- •Severe illness (such as cancer under treatment), being bed-ridden, or unable to move
- •Diagnosed dementia, depression, psychosis, mental disorder, or cannot be effectively communicated with（e.g., MMSE<16）
- •Dumbness, severe hearing or visual impairment, or unable to complete the interview
- •Institutionalized individuals, such as living in a long-term care facility or being hospitalized
结局指标
主要结局
Changed dietary intake
时间窗: Change from Baseline to month 1 and to month 3
Usual dietary intake was assessed by inquiring about most frequently consumed breakfast, lunch, dinner, and snack items and the corresponding amounts by licensed dietitians with the assistance of food models and measuring dishware. Dietary intake data were transformed into nutrient data, using a computerized worksheet based on Nutrition and Health Survey Food and Nutrient Database.
次要结局
- Changed GDS-SF score(Change from Baseline to month 1 and to month 3)
- Changed nutritional status(Change from Baseline to month 1 and to month 3)
- Changed frailty score(Change from baseline to month 1 and to month 3)
- Changed urinary urea nitrogen levels(Change from baseline to month 3)
- Changed urine creatinine levels(Change from baseline to month 3)
研究者
Wen-Harn Pan
Professor
Academia Sinica, Taiwan