A Pilot Study Comparing Effects of Nutrients Supplements and Dietary Approach in Frailty Management
NCT ID: NCT02975089
Last Updated: 2016-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2014-11-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
A leaflet of healthy diet for elderly
No interventions assigned to this group
Nutritional Intervention 1
"Multi-nutrient" supplement
"multi-nutrient" supplement
1. 1.3g/d multivitamins \& minerals powder
2. Leaflet content (same as control)
Nutritional Intervention 2
"Multi-nutrient \& soy protein" supplement
"multi-nutrient & soy protein" supplement
1. 1.3g/d multivitamins \& minerals powder
2. 16g/d isolated soy protein powder
3. Leaflet content (same as control)
Nutritional Intervention 3
Nutrition education on balanced diet \& food supplement
Nutrition education on balanced diet & food 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)
Interventions
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"multi-nutrient" supplement
1. 1.3g/d multivitamins \& minerals powder
2. Leaflet content (same as control)
"multi-nutrient & soy protein" 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 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)
Eligibility Criteria
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Inclusion Criteria
* 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
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
65 Years
ALL
No
Sponsors
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National Health Research Institutes, Taiwan
OTHER
Miao-Li General Hospital, Miao-Li City, Taiwan
UNKNOWN
Academia Sinica, Taiwan
OTHER
Responsible Party
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Wen-Harn Pan
Professor
Principal Investigators
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Wen-Harn Pan, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Institute of Biomedical Sciences, Academia Sinica
Other Identifiers
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AS-IRB-BM-14044
Identifier Type: -
Identifier Source: org_study_id