Effects of Dietary Supplements on Sarcopenic Elders

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Adequate Dietary Protein With Whey Protein, Leucine, and Vitamin D Supplementation on Sarcopenia in Elderly Subjects：An Open-label, Parallel-group Study

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Protison with High Protein 51(Original Flavor)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supp group<br>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. | Dietary Supplement: Protison with High Protein 51(Original Flavor)<br>* Contents of each supplement sachet has a calorie of 88 kcal, 12.8 g protein( including 8.5 g whey protein concentrate), 1.2 g leucine, 7.3 g carbohydrates, 0.8 g fat and 120 IU vitamin D per serving. This supplement was added 200 ml water and stirred well, then drank before meal.<br>|
| No Intervention: Diet group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMMI(appendicular muscle mass index) | 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). | Change measures (baseline and 4 weeks, baseline and 12 weeks) | 
| Handgrip strength | 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. | Change measures (baseline and 4 weeks, baseline and 12 weeks) | 
| Gait speed | 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. | Change measures (baseline and 4 weeks, baseline and 12 weeks) |