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

Primary Purpose

Frail Elderly

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"multi-nutrient" supplement
"multi-nutrient & soy protein" supplement
Nutrition education on balanced diet & food supplement
Sponsored by
Academia Sinica, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frail Elderly focused on measuring Frailty, nutrition education, designed dishware, balanced diet, multiple dietary components

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Control

    Nutritional Intervention 1

    Nutritional Intervention 2

    Nutritional Intervention 3

    Arm Description

    A leaflet of healthy diet for elderly

    "Multi-nutrient" supplement

    "Multi-nutrient & soy protein" supplement

    Nutrition education on balanced diet & food supplement

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 21, 2016
    Last Updated
    November 23, 2016
    Sponsor
    Academia Sinica, Taiwan
    Collaborators
    National Health Research Institutes, Taiwan, Miao-Li General Hospital, Miao-Li City, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02975089
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Academia Sinica, Taiwan
    Collaborators
    National Health Research Institutes, Taiwan, Miao-Li General Hospital, Miao-Li City, Taiwan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frail Elderly
    Keywords
    Frailty, nutrition education, designed dishware, balanced diet, multiple dietary components

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    A leaflet of healthy diet for elderly
    Arm Title
    Nutritional Intervention 1
    Arm Type
    Experimental
    Arm Description
    "Multi-nutrient" supplement
    Arm Title
    Nutritional Intervention 2
    Arm Type
    Experimental
    Arm Description
    "Multi-nutrient & soy protein" supplement
    Arm Title
    Nutritional Intervention 3
    Arm Type
    Experimental
    Arm Description
    Nutrition education on balanced diet & food supplement
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    "multi-nutrient" supplement
    Intervention Description
    1.3g/d multivitamins & minerals powder Leaflet content (same as control)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    "multi-nutrient & soy protein" supplement
    Intervention Description
    1.3g/d multivitamins & minerals powder 16g/d isolated soy protein powder Leaflet content (same as control)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Nutrition education on balanced diet & food supplement
    Intervention Description
    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 Outcome Measure Information:
    Title
    Changed dietary intake
    Description
    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.
    Time Frame
    Change from Baseline to month 1 and to month 3
    Secondary Outcome Measure Information:
    Title
    Changed frailty score
    Description
    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.
    Time Frame
    Change from baseline to month 1 and to month 3
    Title
    Changed GDS-SF score
    Description
    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.
    Time Frame
    Change from Baseline to month 1 and to month 3
    Title
    Changed urinary urea nitrogen levels
    Description
    The first morning urine sample was collected by subjects and brought into the hospital for analyzing urinary urea nitrogen.
    Time Frame
    Change from baseline to month 3
    Title
    Changed urine creatinine levels
    Description
    The first morning urine sample was collected by subjects and brought into the hospital for analyzing urine creatinine.
    Time Frame
    Change from baseline to month 3
    Title
    Changed nutritional status
    Description
    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.
    Time Frame
    Change from Baseline to month 1 and to month 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wen-Harn Pan, Ph.D.
    Organizational Affiliation
    Institute of Biomedical Sciences, Academia Sinica
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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