Effects of Dietary Supplements on Sarcopenic Elders

NCT ID: NCT03860194

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-22
• Study Completion Date: 2017-12-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Protison with High Protein 51(Original Flavor)

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chih-Chien Lin

Attending physician of the Family Medicine Department, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chih-Chien Lin

Role: STUDY_CHAIR

Family Medicine department

Locations

Far Eastern Memorial Hospital

New Taipei City, Banciao Dist, Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 35177293 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32928579 (View on PubMed)

Other Identifiers

FarEasternMH105096F

Identifier Type: -

Identifier Source: org_study_id