Clinical trial NCT02975089: A Pilot Study Comparing Effects of Nutrients Supplements and Dietary Approach in Frailty Management
Official title: A Pilot Study Comparing Effects of Nutrients Supplements and Dietary Approach in Frailty Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Keywords: Frailty
nutrition education
designed dishware
balanced diet
multiple dietary components
Lead sponsor: Academia Sinica, Taiwan
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
name: Miao-Li General Hospital, Miao-Li City, Taiwan
First posted: 2016-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* ≥ 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:

1. unintentional weight loss \> 5% or 3 kg in previous year
2. Exhaustion: defined as positive answer to the question "I had felt fatigue or exhaustion for \>3 days in the previous week"
3. 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
4. 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
5. 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.

Exclusion Criteria:

1. Severe illness (such as cancer under treatment), being bed-ridden, or unable to move
2. Diagnosed dementia, depression, psychosis, mental disorder, or cannot be effectively communicated with（e.g., MMSE\<16）
3. Dumbness, severe hearing or visual impairment, or unable to complete the interview
4. Institutionalized individuals, such as living in a long-term care facility or being hospitalized

Primary outcomes:
measure: Changed dietary intake
timeFrame: Change from Baseline to month 1 and to month 3
Secondary outcomes:
measure: Changed frailty score
timeFrame: Change from baseline to month 1 and to month 3
measure: Changed GDS-SF score
timeFrame: Change from Baseline to month 1 and to month 3
measure: Changed urinary urea nitrogen levels
timeFrame: Change from baseline to month 3
measure: Changed urine creatinine levels
timeFrame: Change from baseline to month 3
measure: Changed nutritional status
timeFrame: Change from Baseline to month 1 and to month 3
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Biomedical Sciences, Academia Sinica
name: Wen-Harn Pan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: