Protein Supplementation Intervention for Improving Muscle Mass and Physical Performance in Older People With Sarcopenia: A Randomized, Double-blind, Placebo-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Asia University
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- Skeletal muscle mass index ("change" is being assessed)
Study Overview
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.
Detailed Description
Background: Sarcopenia is defined as an abnormal loss of muscle mass and strength. 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. Recently, Taiwan is known as the fastest-aging nation in the world, and the prevalence of sarcopenia has been reported as 3.9-7.3%; even more 9-64% in Dr. Chen's study. 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.
Study design: A randomized, double-blind, placebo-controlled clinical trial which will be conducted between September and November, 2020.
Participants: The study will be conducted in Keelung, Taiwan. A total of 9 day-care centers, including 180 over 65 years of residents, will be invited to participate the study via telephone calls.
Eligible participants will be invited to attend this randomized, double-blind, placebo-controlled, 2-parallel-groups trial, and will be randomly assigned to the experimental and control groups with 1:1 ratio.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Masking Description
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.
Eligibility Criteria
- Ages
- 65 Years to 95 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •65-95 years old
- •can communicate in Mandarin or Taiwanese language
- •sacorpenia (basing on criteria of Asian Working Group for Sarcopenia )
Exclusion Criteria
- •with liver or kidney disease
- •stent in body.
Arms & Interventions
Experimental group
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).
Intervention: Protein supplementation (Dietary Supplement)
Control (Placebo) group
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).
Intervention: Placebo oat drink (Dietary Supplement)
Outcomes
Primary Outcomes
Skeletal muscle mass index ("change" is being assessed)
Time Frame: The change is assessed from week 0 (baseline) to week 12
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.
Secondary Outcomes
- 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)