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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07443722
Enrollment
30
Registered
2026-03-02
Start date
2025-09-01
Completion date
2026-08-31
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valid Frailty, Valid Malnutrition Condition, Valid Sarcopenia

Keywords

meal delivery service, nutritional status, mobility, quality of life, depression, elderly people living alone

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTmilk drinks

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.

Sponsors

Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Mini Nutritional Assessment (MNA) scoreBaseline, 3 months, 6 months, 9 months and 12 monthsNutritional 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.
Change in body weightBaseline, 3 months, 6 months, 9 months and 12 monthsBody weight is measured using a calibrated digital scale and expressed in kilograms (kg).
Change in body mass index (BMI)Baseline, 3 months, 6 months, 9 months, 12 monthsBMI is calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Change in skeletal muscle massBaseline, 3 months, 6 months, 9 months, 12 monthsSkeletal muscle mass is measured using a calibrated digital body composition analyzer based on bioelectrical impedance analysis (BIA) and expressed in percentage (%).
Changes in calf circumferenceBaseline, 3 months, 6 months, 9 months and 12 monthsCalf 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).
Changes in muscle strengthBaseline, 3 months, 6 months, 9 months and 12 monthsMuscle strength is assessed using handgrip dynamometry and expressed in kilograms (kg).
Change in five-times chair stand test timeBaseline, 3 months, 6 months, 9 months and 12 monthsLower 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).
Change in gait speedBaseline, 3 months, 6 months, 9 months and 12 monthsUsual 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).
Changes in daily total energy intakeBaseline, 3 months, 6 months, 9 months and 12 monthsDaily 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).
Change in daily protein intakeBaseline, 3months, 6 months, 9 months, 12 monthsDaily 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).
Change in daily carbohydrate intakeBaseline, 3 months, 6 months, 9 months, 12 monthsDaily carbohydrate intake is estimated using a 24-hour dietary recall and expressed in grams per day (g/day).
Change in daily fat intakeBaseline, 3 months, 6 months, 9 months, 12 monthsDaily fat intake is estimated using a 24-hour dietary recall and expressed in grams per day (g/day).
Change in Short-Form Geriatric Depression Scale (GDS-5) scoreBaseline, 6 months and 12 monthsDepressive 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.

Secondary

MeasureTime frameDescription
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) scoreBaseline, 6 months and 12 monthsQuality 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026