Effects of Dietary Supplements on Sarcopenic Elders

NCT03860194 | Completed

• 1 other identifier: FarEasternMH105096F
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Supp group

EXPERIMENTAL

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)

Diet group

NO INTERVENTION

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.

Interventions

Protison with High Protein 51(Original Flavor) DIETARY_SUPPLEMENT

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.

Supp group

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Banciao Dist, 220, Taiwan

Location

Related Publications (2)

• Lin CC, Yeh SL. Reply to the letter to the editor: Effects of adequate dietary protein with whey protein, leucine, and vitamin D supplementation on sarcopenia in older adults: An open-label, parallel-group study. Clin Nutr. 2022 Mar;41(3):792-793. doi: 10.1016/j.clnu.2022.01.030. Epub 2022 Feb 5.

  PMID: 35177293 DERIVED

• Lin CC, Shih MH, Chen CD, Yeh SL. Effects of adequate dietary protein with whey protein, leucine, and vitamin D supplementation on sarcopenia in older adults: An open-label, parallel-group study. Clin Nutr. 2021 Mar;40(3):1323-1329. doi: 10.1016/j.clnu.2020.08.017. Epub 2020 Aug 27.

  PMID: 32928579 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Chih-Chien Lin

  Family Medicine department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician of the Family Medicine Department, Principal Investigator

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: March 1, 2019
• Study Start: March 22, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)