Effects of Dietary Supplements on Sarcopenic Elders

Sponsor
Far Eastern Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03860194
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Protison with High Protein 51(Original Flavor)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 22, 2017
Actual Primary Completion Date :
Dec 30, 2017
Actual Study Completion Date :
Dec 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supp group

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)
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.

No Intervention: Diet group

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.

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Older adults (≥ 65 years)

  • Subject has lower appendicular muscle mass index (AMMI) (<7 kg/m2 in men; <5.7 kg/m2 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Far Eastern Memorial Hospital New Taipei City Banciao Dist Taiwan 220

Sponsors and Collaborators

  • Far Eastern Memorial Hospital

Investigators

  • Study Chair: Chih-Chien Lin, Family Medicine department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chih-Chien Lin, Attending physician of the Family Medicine Department, Principal Investigator, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT03860194
Other Study ID Numbers:
  • FarEasternMH105096F
First Posted:
Mar 1, 2019
Last Update Posted:
Mar 20, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2019