NCT02490410

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 3, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

June 30, 2015

Last Update Submit

July 2, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • plasma amino acid spectrum, especially branched chain amino acid spectrum

    up to 6 months

Study Arms (3)

whey protein

EXPERIMENTAL

2 x 10g whey protein per day orally for 6 months

Dietary Supplement: protein supplement

whey protein+soy protein

OTHER

10g whey protein + 10g soy protein per day orally for 6 months

Dietary Supplement: protein supplement

soy protein

OTHER

2 x 10g soy protein per day orally for 6 months

Dietary Supplement: protein supplement

Interventions

protein supplementDIETARY_SUPPLEMENT
soy proteinwhey proteinwhey protein+soy protein

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Zhu Hui lian, professor

CONTACT

+86 20 87331811zhuhl@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 3, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 3, 2015

Record last verified: 2015-07