Effects of Dietary Supplements on Sarcopenic Elders

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860194
• Other study ID #: FarEasternMH105096F
• Status: Completed
• Phase: N/A
• Start date: March 22, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: March 2019
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	New Taipei City	Banciao Dist

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)