Effects of Whey Protein Intervention on Body Composition and Muscle Function in the Elderly With Sacropenia

Healthy Clinical Trial

Official title:

A Double-blind Randomized Controlled Study About the Effects of Whey Protein Intervention on Body Composition and Muscular Function in the Elderly With Sacropenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02490410
• Other study ID #: CNS-YILI2014-034
• Status: Not yet recruiting
• Phase: N/A
• First received: June 30, 2015
• Last updated: July 2, 2015
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2015
• Source: Sun Yat-sen University
• Contact: Zhu Hui lian, professor
• Phone: +86 20 87331811
• Email: zhuhl[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of different dose of whey protein intervention(in a daily dose of 0g, 10g, 20g) on lean body mass,body fat composition and muscular function state in the elderly with sacropenia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• People aged over 65 years.

• Usual gait speed less than 0.8m/s.

• Willing to participate in the study, consume the test product and perform all measurements.

Exclusion Criteria:

• nervous system disease.

• Other diseases with movement disorder such as stroke,fracture,arthritis.

• people who unconsciousness and can not complete questionnaire

• long-term regular use of protein and antioxidant.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• protein supplement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huilian Zhu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lean body mass	At baseline, 3 and 6 months, investigators will use DXA to examine lean body mass and body fat composition	up to 6 months	No
Primary	muscular function state	At baseline, 3 and 6 months, investigators will use the Short Physical Performance Battery (SPPB) to test muscular function state	up to 6 months	No
Secondary	plasma amino acid spectrum, especially branched chain amino acid spectrum	At baseline and 6 months, blood samples will be drawn and plasma amino acid spectrum, especially branched chain amino acid spectrum will be tested	up to 6 months	No