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Frail ElderlyNCT02975089

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

A study testing "multi-nutrient" supplement, "multi-nutrient & soy protein" supplement and Nutrition education on balanced diet & food supplement in people with Frail Elderly, run by Academia Sinica, Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frail Elderly
What is being tested?
"multi-nutrient" supplement, "multi-nutrient & soy protein" supplement and Nutrition education on balanced diet & food supplement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Nov 2014to Jul 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • ≥ 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"
Show all 11Show fewer
  • 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.

Who cannot join

  • 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

About this study

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.

Conditions
Frail Elderly
Being tested
"multi-nutrient" supplement, "multi-nutrient & soy protein" supplement, Nutrition education on balanced diet & food supplement
Keywords
Frailty, nutrition education, designed dishware, balanced diet, multiple dietary components
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "multi-nutrient" supplementDietary supplement

    1. 1.3g/d multivitamins \& minerals powder
    2. Leaflet content (same as control)

  • "multi-nutrient & soy protein" supplementDietary supplement

    1. 1.3g/d multivitamins \& minerals powder
    2. 16g/d isolated soy protein powder
    3. Leaflet content (same as control)

  • Nutrition education on balanced diet & food supplementDietary supplement

    1. Nutrition education with a designed plate
    2. 10g/d mixed nuts (cashews, pumpkin seeds, walnuts, macadamia, pine nuts, and almonds)
    3. 25g/d milk powder (skimmed and calcium added)
    4. Leaflet content (same as control)
Study groups in NCT02975089
Study groupRoleWhat they receive
ControlNo interventionA leaflet of healthy diet for elderly
Nutritional Intervention 1Experimental"Multi-nutrient" supplement
Receives: Dietary Supplement: "multi-nutrient" supplement
Nutritional Intervention 2Experimental"Multi-nutrient \& soy protein" supplement
Receives: Dietary Supplement: "multi-nutrient & soy protein" supplement
Nutritional Intervention 3ExperimentalNutrition education on balanced diet \& food supplement
Receives: Dietary Supplement: Nutrition education on balanced diet & food supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from Baseline to month 1 and to month 3

Secondary outcomes (5)

  1. 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.

    Measured: Change from baseline to month 1 and to month 3

  2. 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.

    Measured: Change from Baseline to month 1 and to month 3

  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.

    Measured: Change from baseline to month 3

  4. Changed urine creatinine levels

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

    Measured: Change from baseline to month 3

  5. 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.

    Measured: Change from Baseline to month 1 and to month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2016 (estimated)
  2. Study startNov 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02975089
Sponsor's protocol ID
AS-IRB-BM-14044
Status last verified
Nov 2016
First submitted
21 Sep 2016
Last updated
29 Nov 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing "multi-nutrient" supplement, "multi-nutrient & soy protein" supplement and Nutrition education on balanced diet & food supplement in people with Frail Elderly, run by Academia Sinica, Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changed dietary intake (time frame: Change from Baseline to month 1 and to month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02975089.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.

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