Effects of Dietary Supplements on Sarcopenic Elders

Far Eastern Memorial Hospital

Status: Completed

Conditions: Sarcopenia

Treatments: Dietary Supplement: Protison with High Protein 51(Original Flavor)

Study type: Interventional

Funder types: Other

Identifiers

NCT03860194

FarEasternMH105096F

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 65 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Supp group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Protison with High Protein 51(Original Flavor)

Diet group

No Intervention group

Description:

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 Diet group were instructed to consume ordinary high protein foods to achieve 1.5 g protein/kg body weight (BW)/day on the basis of this guideline, and suggested to equally distribute their meal time.