Effect of Nutrition Supplementation Combined With Resistance Exercise in Elderly With Sarcopenia.

NCT ID: NCT05035121

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-24

Study Completion Date

2018-03-23

Brief Summary

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The purpose of this study was determine whether milk or soy milk supplements combined with resistance exercise improved sarcopenia in the elderly. This study was randomized controlled trail that recruited elderly people ≧65 years old with sarcopenia in the nursing home of Taipei Veterans General Hospital Su-Ao and Yuanshan Branch from June 2017 to December, 2017. The participants were divided into three groups, such as control, milk supplement and soy milk supplement. The milk and soy milk groups provided 200 mL milk or soy milk two times per day. Moreover, all participants joined the resistance exercise training program, three times per week (30 min/time). After 12 weeks, the anthropometry, sarcopenia index, blood biochemical index, nutrition status index, inflammation index, insulin resistance index, and dietary intake were measured.

Detailed Description

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The anthropometry data included body weight and body fat. The sarcopenia index included appendicular skeletal muscle mass index, calf circumferences, hand grip and gait speed. Moreover, blood biochemical index (liver function as ALT, kidney function as creatinine), nutrition status index (prealbumin, 25-hydroxyvitamin D) were also analyzed. The blood hsCRP level was as inflammation index and insulin resistance index included fasting blood sugar, insulin, HbA1c and HOMA-IR. The daily dietary intake were also recorded.

Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants were divided into three groups, such as control, milk supplement and soy milk supplement. The milk and soy milk groups provided 200 mL milk or soy milk two times per day. Moreover, all participants joined the resistance exercise training program, three times per week (30min/time).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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milk supplement

The milk group provided 200 mL milk two times per day. The participants joined the resistance exercise training program, three times per week (30 min/time) during 12 weeks.

Group Type EXPERIMENTAL

milk supplement

Intervention Type DIETARY_SUPPLEMENT

Intervention groups provided 200 mL long life milk two times per day at morning and afternoon. The participants joined the resistance exercise training program, three times per week (30 min/time)

resistance exercise

Intervention Type BEHAVIORAL

The participants joined the resistance exercise training program, three times per week (30 min/time)

soy milk supplement

The soy milk group provided 200 mL soy milk two times per day. The participants joined the resistance exercise training program, three times per week (30 min/time) during 12 weeks.

Group Type EXPERIMENTAL

soy milk supplement

Intervention Type DIETARY_SUPPLEMENT

Intervention groups provided 200 mL long life soy milk two times per day at morning and afternoon. The participants joined the resistance exercise training program, three times per week (30 min/time)

resistance exercise

Intervention Type BEHAVIORAL

The participants joined the resistance exercise training program, three times per week (30 min/time)

control

The participants joined the resistance exercise training program, three times per week (30 min/time) during 12 weeks.

Group Type PLACEBO_COMPARATOR

resistance exercise

Intervention Type BEHAVIORAL

The participants joined the resistance exercise training program, three times per week (30 min/time)

Interventions

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milk supplement

Intervention groups provided 200 mL long life milk two times per day at morning and afternoon. The participants joined the resistance exercise training program, three times per week (30 min/time)

Intervention Type DIETARY_SUPPLEMENT

soy milk supplement

Intervention groups provided 200 mL long life soy milk two times per day at morning and afternoon. The participants joined the resistance exercise training program, three times per week (30 min/time)

Intervention Type DIETARY_SUPPLEMENT

resistance exercise

The participants joined the resistance exercise training program, three times per week (30 min/time)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age ≧ 65 years old
* No allergies to milk and soy milk
* Sarcopenia cases (AWGS)
* Active ability

Exclusion Criteria

* End-of-life patient or estimated death within six months
* Last stage of cancer
* Chronic kidney disease stage 4
Minimum Eligible Age

65 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jiun-Rong Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taipei Medical University

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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N201702034

Identifier Type: -

Identifier Source: org_study_id

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