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

NCT05035121 | Completed

• 1 other identifier: N201702034
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia

Keywords

sarcopenia; milk; soy milk; resistance exercise

Outcome Measures

Primary Outcomes (18)

• appendicular skeletal muscle mass in kilograms

  The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)

  baseline

• Change from baseline appendicular skeletal muscle mass at 6 weeks

  The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)

  6 weeks

• Change from baseline appendicular skeletal muscle mass at 12 weeks

  The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)

  12 weeks

• height in meters

  Height was measured by height meter

  baseline

• Change baseline weeks height at 6 weeks

  Height was measured by height meter

  6 weeks

• Change from baseline height at 12 weeks

  Height was measured by height meter

  12 weeks

• appendicular skeletal muscle mass index in kg/m^2

  The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m\^2.

  baseline

• Change from baseline appendicular skeletal muscle mass index at 6 weeks

  The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m\^2.

  6 weeks

• Change from baseline appendicular skeletal muscle mass index at 12 weeks

  The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m\^2.

  12 weeks

• calf circumferences in centimeter

  calf circumferences (cm) was measured by using a measuring tape to go around the thickest point of the calf and stick tightly without squeezing the skin.

  baseline

• Change from baseline calf circumferences at 6 weeks

  calf circumferences (cm) was measured by using a measuring tape to go around the thickest point of the calf and stick tightly without squeezing the skin.

  6 weeks

• Change from baseline calf circumferences at 12 weeks

  calf circumferences (cm) was measured by using a measuring tape to go around the thickest point of the calf and stick tightly without squeezing the skin.

  12 weeks

• hand grip in kilograms

  The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan)

  baseline

• Change from baseline hand grip at 6 weeks

  The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan)

  6 weeks

• Change from baseline hand grip at 12 weeks

  The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan)

  12 weeks

• gait speed in meter per second

  The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second.

  baseline

• Change from baseline gait speed at 6 weeks

  The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second.

  6 weeks

• Change from baseline gait speed at 12 weeks

  The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second.

  12 weeks

Secondary Outcomes (20)

• blood alanine transaminase activity in U/L

  baseline

• Change from baseline blood alanine transaminase activity at 12 weeks

  12 weeks

• blood creatinine level in mg/dL

  baseline

• Change from baseline blood creatinine level at 12 weeks

  12 weeks

• blood prealbumin level in mg/dL

  baseline

Other Outcomes (2)

• diet assessment

  baseline

• Change from baseline diet assessment at 12 weeks

  12 weeks

Study Arms (3)

milk supplement

EXPERIMENTAL

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.

Dietary Supplement: milk supplement; Behavioral: resistance exercise

soy milk supplement

EXPERIMENTAL

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.

Dietary Supplement: soy milk supplement; Behavioral: resistance exercise

control

PLACEBO COMPARATOR

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

Behavioral: resistance exercise

Interventions

milk supplement 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)

milk supplement

soy milk supplement 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)

soy milk supplement

resistance exercise BEHAVIORAL

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

control; milk supplement; soy milk supplement

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• End-of-life patient or estimated death within six months
• Last stage of cancer
• Chronic kidney disease stage 4

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

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

Model Details: 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).

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: September 5, 2021
• Study Start: March 24, 2017
• Primary Completion: January 23, 2018
• Study Completion: March 23, 2018
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

TW (1)