Effects of Dietary Supplements on Sarcopenic Elders

Not Applicable

Completed

• Conditions: Sarcopenia
• Interventions: Dietary Supplement: Protison with High Protein 51(Original Flavor)

• Registration Number: NCT03860194
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

Sarcopenia is defined as a syndrome characterized by decline of skeletal muscle mass and strength or an alteration in physical function. Although some studies showed nutritional supplementation alone might have health benefits for older sarcopenic patients, the results were inconsistent and remain controversial. The objective of this study was to evaluate if a sufficient protein diet including supplements with leucine-enriched whey protein and vitamin D can lead to better improvement than sufficient dietary protein alone in maintaining muscle mass and strength among sarcopenic elders.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-22
• Primary Completion: 2017-12-30
• Study Completion: 2017-12-30
• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-02-28
• Status Verified: 2019-03
• Study First Posted: 2019-03-01
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Older adults (≥ 65 years)
• Subject has lower appendicular muscle mass index (AMMI) (<7 kg/m^2 in men; <5.7 kg/m^2 in women) using Bioelectrical impedance analysis (BIA, TANITA BC-418®, Tokyo, Japan)
• Subject has lower handgrip strength (<26 kg in men; <18 kg in women) using dynamometer (CAMRY®, Zhongshan, Guangdong) or slowly gait speed (<1 m/s)

Exclusion Criteria

• Subject's life expectancy was shorter than 6 months
• Nursing home resident
• Subject has the history of kidney failure
• Subject has the history of liver failure
• Subject has the history of diabetes mellitus
• Subject has resistance exercise habit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supp group	Protison with High Protein 51(Original Flavor)	Each participant received nutritional counseling and recommended each of them to consume 1.5 g protein/kg body weight (BW)/day. Participants were encouraged to consume a balanced diet with six food groups follow "Daily dietary guideline of 2013 " as recommended by the Ministry of Health and Welfare of Taiwan. However, 1.2 g protein/kg body weight (BW)/day was suggested from this guideline. Subjects in the Supp group were provided with Protison with High Protein 51(Original Flavor) containing supplements in addition to their regular daily meals to achieve 1.5 g protein/kg (BW)/day on the basis of this guideline.

Primary Outcome Measures

Name	Time	Method
Handgrip strength	Change measures (baseline and 4 weeks, baseline and 12 weeks)	Hand dynamometer was used to measure handgrip strength. Subject was asked to sit in an upright position with the upper arm forming a virtually 90 degree angle with the forearm. Three consecutive measurements of grip strength obtained from both hands were recorded and average of the highest value was calculated as the maximum grip strength. The unit of handgrip strength was represented as kilogram.
AMMI(appendicular muscle mass index)	Change measures (baseline and 4 weeks, baseline and 12 weeks)	Bioelectrical impedance analysis was used to obtain appendicular muscle mass (AMM) and height. The unit of AMM and height were represented as kilogram and meter respectively. AMMI were calculated as AMM/height\^2 (kg/m\^2).
Gait speed	Change measures (baseline and 4 weeks, baseline and 12 weeks)	Asking the subjects to perform a 5-meter walk at their usual pace and measure how much second they could complete this distance, then the unit of gait speed was represented as m/s.

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 New Taipei City, Banciao Dist, Taiwan