A Pilot Study Comparing Effects of Nutrients Supplements and Dietary Approach in Frailty Management

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.

Study Overview

• Status: Completed
• Conditions: Frail Elderly
• Intervention / Treatment: Dietary supplement: "multi-nutrient" supplement; Dietary supplement: "multi-nutrient & soy protein" supplement; Dietary supplement: Nutrition education on balanced diet & food supplement

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; A leaflet of healthy diet for elderly
Experimental: Nutritional Intervention 1; "Multi-nutrient" supplement	Dietary supplement: "multi-nutrient" supplement; 1.3g/d multivitamins & minerals powder; Leaflet content (same as control)
Experimental: Nutritional Intervention 2; "Multi-nutrient & soy protein" supplement	Dietary supplement: "multi-nutrient & soy protein" supplement; 1.3g/d multivitamins & minerals powder; 16g/d isolated soy protein powder; Leaflet content (same as control)
Experimental: Nutritional Intervention 3; Nutrition education on balanced diet & food supplement	Dietary supplement: Nutrition education on balanced diet & food supplement; Nutrition education with a designed plate; 10g/d mixed nuts (cashews, pumpkin seeds, walnuts, macadamia, pine nuts, and almonds); 25g/d milk powder (skimmed and calcium added); Leaflet content (same as control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changed dietary intake	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.	Change from Baseline to month 1 and to month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changed frailty score	All participants were evaluated for frailty, based on the modified Fried criteria. Five frail phenotypes were assigned: (1) unintentional weight loss, (2) self-reported exhaustion, (3) weak grip strength, (4) slow gait speed, and (5) low level of physical activity. For estimating frailty score, participants scored one point from each phenotype if any of which was satisfied with a maximal score of 5 in total. Participants were classified as pre-frail by one point, and as frail by 3 or more points, otherwise as robust.	Change from baseline to month 1 and to month 3
Changed GDS-SF score	Geriatric depression scale-short form (GDS-SF) Chinese version is a 15-item assessment used to identify depression in the elderly. Participants with 5-9 points were at risk of depression, and ≥10 points were depression.	Change from Baseline to month 1 and to month 3
Changed urinary urea nitrogen levels	The first morning urine sample was collected by subjects and brought into the hospital for analyzing urinary urea nitrogen.	Change from baseline to month 3
Changed urine creatinine levels	The first morning urine sample was collected by subjects and brought into the hospital for analyzing urine creatinine.	Change from baseline to month 3
Changed nutritional status	Nutritional status was assessed by mini nutritional assessment-short form (MNA-SF). MNA-SF point ≥12 was of normal nutritional status; between 8 and 11 was at risk for malnutrition; ≤7 was at malnutrition status.	Change from Baseline to month 1 and to month 3

Collaborators and Investigators

• Sponsor: Academia Sinica, Taiwan
• Collaborators: National Health Research Institutes, Taiwan; Miao-Li General Hospital, Miao-Li City, Taiwan

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Estimate): November 29, 2016
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: nutrition education; Frailty; balanced diet; designed dishware; multiple dietary components
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: AS-IRB-BM-14044