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NCT Number: NCT02975089

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.

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Key information

Conditions

Frail Elderly Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

"multi-nutrient" supplement

Dietary Supplement
  • 1.3g/d multivitamins & minerals powder
  • Leaflet content (same as control)

"multi-nutrient & soy protein" supplement

Dietary Supplement
  • 1.3g/d multivitamins & minerals powder
  • 16g/d isolated soy protein powder
  • Leaflet content (same as control)

Nutrition education on balanced diet & food supplement

Dietary 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)

Primary outcomes

  1. Changed dietary intake

    Time frame: 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.

Secondary outcomes

  1. Changed frailty score

    Time frame: Change from baseline to month 1 and to month 3

    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.

  2. Changed GDS-SF score

    Time frame: Change from Baseline to month 1 and to month 3

    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.

  3. Changed urinary urea nitrogen levels

    Time frame: Change from baseline to month 3

    The first morning urine sample was collected by subjects and brought into the hospital for analyzing urinary urea nitrogen.

  4. Changed urine creatinine levels

    Time frame: Change from baseline to month 3

    The first morning urine sample was collected by subjects and brought into the hospital for analyzing urine creatinine.

  5. Changed nutritional status

    Time frame: Change from Baseline to month 1 and to month 3

    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.

Sponsors and collaborators

Lead sponsor

Academia Sinica, Taiwan

Other

Collaborators

  • Miao-Li General Hospital, Miao-Li City, Taiwan
  • National Health Research Institutes, Taiwan

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 29, 2016
Registry last updated
Nov 29, 2016

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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