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NCT Number: NCT07443722

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Valid Malnutrition Condition Behavior Behavioral Symptoms Depression Valid Frailty Valid Sarcopenia

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, 110, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

milk drinks

Dietary Supplement

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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 (%).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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