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

NCT ID: NCT02975089

Last Updated: 2016-11-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Frail Elderly

Keywords

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Frailty nutrition education designed dishware balanced diet multiple dietary components

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Control

A leaflet of healthy diet for elderly

Group Type NO_INTERVENTION

No interventions assigned to this group

Nutritional Intervention 1

"Multi-nutrient" supplement

Group Type EXPERIMENTAL

"multi-nutrient" supplement

Intervention Type DIETARY_SUPPLEMENT

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

Nutritional Intervention 2

"Multi-nutrient \& soy protein" supplement

Group Type EXPERIMENTAL

"multi-nutrient & soy protein" supplement

Intervention Type DIETARY_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

Group Type EXPERIMENTAL

Nutrition education on balanced diet & food supplement

Intervention Type DIETARY_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)

Intervention Type DIETARY_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)

Intervention Type DIETARY_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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health Research Institutes, Taiwan

OTHER

Sponsor Role collaborator

Miao-Li General Hospital, Miao-Li City, Taiwan

UNKNOWN

Sponsor Role collaborator

Academia Sinica, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Wen-Harn Pan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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