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

NCT02975089 | Completed DMC

• 1 other identifier: AS-IRB-BM-14044
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Frail Elderly

Keywords

Frailty; nutrition education; designed dishware; balanced diet; multiple dietary components

Outcome Measures

Primary Outcomes (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.

  Change from Baseline to month 1 and to month 3

Secondary Outcomes (5)

• Changed frailty score

  Change from baseline to month 1 and to month 3

• Changed GDS-SF score

  Change from Baseline to month 1 and to month 3

• Changed urinary urea nitrogen levels

  Change from baseline to month 3

• Changed urine creatinine levels

  Change from baseline to month 3

• Changed nutritional status

  Change from Baseline to month 1 and to month 3

Study Arms (4)

Control

NO INTERVENTION

A leaflet of healthy diet for elderly

Nutritional Intervention 1

EXPERIMENTAL

"Multi-nutrient" supplement

Dietary Supplement: "multi-nutrient" supplement

Nutritional Intervention 2

EXPERIMENTAL

"Multi-nutrient \& soy protein" supplement

Dietary Supplement: "multi-nutrient & soy protein" supplement

Nutritional Intervention 3

EXPERIMENTAL

Nutrition education on balanced diet \& food supplement

Dietary Supplement: Nutrition education on balanced diet & food supplement

Interventions

"multi-nutrient" supplement DIETARY_SUPPLEMENT

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

Nutritional Intervention 1

"multi-nutrient & soy protein" supplement DIETARY_SUPPLEMENT

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

Nutritional Intervention 2

Nutrition education on balanced diet & food supplement 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)

Nutritional Intervention 3

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Academia Sinica, Taiwan: lead
• National Health Research Institutes, Taiwan: collaborator
• Miao-Li General Hospital, Miao-Li City, Taiwan: collaborator

MeSH Terms

Conditions

Frailty

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Wen-Harn Pan, Ph.D.

  Institute of Biomedical Sciences, Academia Sinica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: November 29, 2016
• Study Start: November 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 29, 2016

Record last verified: 2016-11