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

NCT02975089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-11-29

No results posted yet for this study

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.

Conditions

  • Frail Elderly

Interventions

DIETARY_SUPPLEMENT

"multi-nutrient" supplement

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

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)

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)

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    collaborator OTHER
  • Miao-Li General Hospital, Miao-Li City, Taiwan

    collaborator UNKNOWN
  • Academia Sinica, Taiwan

    lead OTHER

Principal Investigators

  • Wen-Harn Pan, Ph.D. · Institute of Biomedical Sciences, Academia Sinica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-07-31
Completion
2015-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02975089 on ClinicalTrials.gov