The Beneficial Effects of Nutritional Supplements on the Malnutrition and Sarcopenia Risk in Elderly Living Alone

February 26, 2026 updated by: Suh-Ching, Yang, Taipei Medical University
This study aims to examine the effects of meal delivery services on the nutritional status and mobility of malnourished older adults living alone at a foundation in Taoyuan. Participants will continue their usual diet and consume a daily oral nutrition supplement (ONS) of their preferred type (instant powder with milk or soy milk), provided monthly by social workers for 12 months. Nutritional assessments will be conducted every three months, including the Mini Nutritional Assessment (MNA), anthropometric measures, and 24-hour dietary recall. Mobility will be evaluated using grip strength, walking speed, chair stand test, and calf circumference. Psychological outcomes will be assessed every six months using a quality-of-life questionnaire and the short form of the Geriatric Depression Scale. This study is expected to determine whether regular meal delivery services can improve nutritional status, mobility, quality of life, and depressive symptoms among elderly individuals living alone.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan, 110
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mini Nutritional Assessment (MNA) score < 23.5, Body mass index (BMI) < 25 kg/m², Calf circumference: < 34 cm for men and < 33 cm for women, Handgrip strength: < 28 kg for men and < 18 kg for women

Exclusion Criteria:

  • Presence of swallowing difficulties (dysphagia), Chronic renal failure, Bedridden and unable to ambulate, Older adults with chronic conditions-such as hypertension, cardiovascular disease, or poorly controlled diabetes-who are deemed unsuitable after professional assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: malnourished older adults living alone
Without adjusting their daily diet, they take oral nutrition supplements (ONS) once a day according to their favorite combination. The items include: instant powder with milk drinks or soy milk, which are distributed by social workers every month for a total of 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mini Nutritional Assessment (MNA) score
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
Nutritional status is assessed using the Mini Nutritional Assessment (MNA). The total MNA score ranges from 0 to 30, with lower scores indicating poorer nutritional status. The score is expressed as a total point value.
Baseline, 3 months, 6 months, 9 months and 12 months
Change in body weight
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
Body weight is measured using a calibrated digital scale and expressed in kilograms (kg).
Baseline, 3 months, 6 months, 9 months and 12 months
Change in body mass index (BMI)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
BMI is calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Baseline, 3 months, 6 months, 9 months, 12 months
Change in skeletal muscle mass
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
Skeletal muscle mass is measured using a calibrated digital body composition analyzer based on bioelectrical impedance analysis (BIA) and expressed in percentage (%).
Baseline, 3 months, 6 months, 9 months, 12 months
Changes in calf circumference
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
Calf circumference is used as a surrogate indicator of muscle mass. Calf circumference is measured at the widest point of the non-dominant calf using a non-elastic measuring tape and expressed in centimeters (cm).
Baseline, 3 months, 6 months, 9 months and 12 months
Changes in muscle strength
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
Muscle strength is assessed using handgrip dynamometry and expressed in kilograms (kg).
Baseline, 3 months, 6 months, 9 months and 12 months
Change in five-times chair stand test time
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
Lower extremity muscle strength will be assessed using the five-times chair stand test. The time required to complete five consecutive chair rises will be recorded in seconds (s).
Baseline, 3 months, 6 months, 9 months and 12 months
Change in gait speed
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
Usual gait speed is assessed using a standardized 6-meter walk test. Participants will be instructed to walk at their usual pace, and walking speed will be expressed in meters per second (m/s).
Baseline, 3 months, 6 months, 9 months and 12 months
Changes in daily total energy intake
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
Daily energy intake is estimated using a 24-hour dietary recall and analyzed using nutrition analysis software. Energy intake will be expressed in kilocalories per day (kcal/day).
Baseline, 3 months, 6 months, 9 months and 12 months
Change in daily protein intake
Time Frame: Baseline, 3months, 6 months, 9 months, 12 months
Daily protein intake is estimated using a 24-hour dietary recall and analyzed using nutrition analysis software. Protein intake is expressed in grams per day (g/day).
Baseline, 3months, 6 months, 9 months, 12 months
Change in daily carbohydrate intake
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
Daily carbohydrate intake is estimated using a 24-hour dietary recall and expressed in grams per day (g/day).
Baseline, 3 months, 6 months, 9 months, 12 months
Change in daily fat intake
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
Daily fat intake is estimated using a 24-hour dietary recall and expressed in grams per day (g/day).
Baseline, 3 months, 6 months, 9 months, 12 months
Change in Short-Form Geriatric Depression Scale (GDS-5) score
Time Frame: Baseline, 6 months and 12 months
Depressive symptoms is assessed using the 5-item Short-Form Geriatric Depression Scale (GDS-5). The total score ranges from 0 to 5, with higher scores indicating more severe depressive symptoms. Scores is expressed as total points.
Baseline, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) score
Time Frame: Baseline, 6 months and 12 months
Quality of life is assessed using the Taiwan version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF). The instrument includes 26 items covering four domains (physical health, psychological health, social relationships, and environment). Domain scores is transformed to a scale ranging from 0 to 100, with higher scores indicating better quality of life.
Baseline, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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