Protein Supplementation Intervention for Improving Muscle Mass and Physical Performance in Older People With Sarcopenia

NCT04516421 | Unknown

• 1 other identifier: JWang20-CF01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

Background: Declines in muscle mass and strength are expected with aging, but physical inactivity and low protein intake have been suggested as risk factors of sarcopenia. So far, lifestyle interventions, especially exercise and nutritional supplementation, prevail as mainstays of treatment for sarcopenia. Objective: To explore the effect and benefits of protein supplementation on the improvement of muscle mass and physical performance in older people with sarcopenia. Design: A randomized, double-blind, placebo-controlled clinical trial. Methods: Participants aged 65-95y who meet the following criteria will be invited: (1) muscle mass: bioimpedance, \<7.0 kg/m² (male) and \<5.7 kg/m² (female), (2) handgrip strength: \<28 kg (male) and \<18 kg (female), and (3) low physical performance: 6-m gait Speed \<1.0 m/s. Study participants will be randomly assigned to two groups. The experimental group will receive a 12-week intervention with【protein (14g)+ BCAA(4.4g)】 drink per day, while the parallel control group will receive a placebo oat drink per day. Participants in the control group will be asked to maintain participants' usual diet and physical activity. There are 3 time-points to measure outcomes and observe other required information, at week 0(baseline), 6 and 12.

Conditions

Sarcopenia

Keywords

older people; sarcopenia; handgrip strength; muscle mass

Outcome Measures

Primary Outcomes (1)

• Skeletal muscle mass index ("change" is being assessed)

  Bioimpedance is adopted to assess sarcopenia. Therefore, Skeletal muscle mass index is measured by bioimpedance( using the In body instrument Model 230) and means ASM/H²((sum of lean muscle mass in upper and lower limb divided by square of body height). Skeletal muscle mass index is used with a cut-off value of 7 kg/m² in men, and 5.4 kg/m² in women according to the AWGS 2020.

  The change is assessed from week 0 (baseline) to week 12

Secondary Outcomes (2)

• Hand-grip strength ("change" is being assessed)

  The change is assessed from week 0 (baseline) to week 12

• Gait speed ("change" is being assessed)

  The change is assessed from week 0 (baseline) to week 12

Other Outcomes (8)

• Short Physical Performance Battery ("change" is being assessed)

  The change is assessed from week 0 (baseline) to week 12

• Instrumental Activities of Daily Living ("change" is being assessed)

  The change is assessed from week 0 (baseline) to week 12

• Mini-Mental State Examination ("change" is being assessed)

  The change is assessed from week 0 (baseline) to week 12

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will receive a 12-weeks intervention, with each day a pack of supplementation containing 14g protein, 0.6g fat, 7g carbohydrate, 4.4 g BCAA , 2.4g glutamate, 0.5g arginine and 0.4g taurine with 90 kcal/pack (Affix Health, Taiwan Branch).

Dietary Supplement: Protein supplementation

Control (Placebo) group

PLACEBO COMPARATOR

The control (placebo) group will receive a 12-week oat drink, with each day a pack of oat tea containing 1.5g protein, 0.5g fat, 0.1g carbohydrate with 8.3kcal/pack (Zhan Xuan, Co. Ltd., Taiwan).

Dietary Supplement: Placebo oat drink

Interventions

Protein supplementation DIETARY_SUPPLEMENT

The experimental group contained 14g protein, 0.6g fat, 7g carbohydrate, 4.4 g BCAA , 2.4g glutamate, 0.5g arginine and 0.4g taurine with 90 kcal/pack (Affix Health, Taiwan Branch).

Experimental group

Placebo oat drink DIETARY_SUPPLEMENT

placebo oat drink contained 1.5g protein, 0.5g fat, 0.1g carbohydrate with 8.3kcal/pack (Zhan Xuan, Co. Ltd., Taiwan).

Control (Placebo) group

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years old
• can communicate in Mandarin or Taiwanese language
• sacorpenia (basing on criteria of Asian Working Group for Sarcopenia )

You may not qualify if:

• with liver or kidney disease
• stent in body.

Sponsors & Collaborators

• Asia University: lead

Study Sites (3)

Keelung Hospital Daycare Center, Ministry of Health and Welfare

Keelung, 201, Taiwan

Location

Keelung First Daycare Center

Keelung, 202, Taiwan

Location

Keelung Second Daycare Center

Keelung, 206, Taiwan

Location

Related Publications (1)

• Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

  PMID: 32033882 RESULT

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Chang

  Ching Kuo Institute of Management and Health, Keelung, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: After random assignment, the external researcher newly assigned a subject ID to each participant. All other study personnel and participants remained blinded to the identity codes throughout the course of the study. When participants withdrew from or completed the study, researchers were provided with the participants' identities, and the participants were told what supplement they had received.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Then eligible participants is invited to attend this randomized, double-blind, placebo-controlled,2-parallel-group trial, and concealed allocation and intention-to-treat (ITT) analysis were applied, and randomly assigned to the experimental and control group in the ratio of 1:1 for the 12-week trial. and intervention.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 18, 2020
• Study Start: August 24, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2022
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)