HealthyNCT02490410
Effects of Whey Protein Intervention on Body Composition and Muscle Function in the Elderly With Sacropenia
A study testing protein supplement in people with Healthy, run by Huilian Zhu.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- protein supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- protein supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein supplementDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| whey protein | Experimental | 2 x 10g whey protein per day orally for 6 months Receives: Dietary Supplement: protein supplement |
| whey protein+soy protein | Other | 10g whey protein + 10g soy protein per day orally for 6 months Receives: Dietary Supplement: protein supplement |
| soy protein | Other | 2 x 10g soy protein per day orally for 6 months Receives: Dietary Supplement: protein supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
lean body mass
At baseline, 3 and 6 months, investigators will use DXA to examine lean body mass and body fat composition
Measured: 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
Measured: up to 6 months
Secondary outcomes (1)
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
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huilian Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huilian Zhu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490410
- Sponsor's protocol ID
- CNS-YILI2014-034
- Status last verified
- Jul 2015
- First submitted
- 30 Jun 2015
- Last updated
- 3 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02490410
- Acronym / sponsor ID
- CNS-YILI2014-034
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Huilian ZhuUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| whey protein | Experimental | Dietary Supplement: protein supplement2 x 10g whey protein per day orally for 6 months |
| whey protein+soy protein | Other | Dietary Supplement: protein supplement10g whey protein + 10g soy protein per day orally for 6 months |
| soy protein | Other | Dietary Supplement: protein supplement2 x 10g soy protein per day orally for 6 months |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein supplement | Dietary supplement | soy protein, whey protein, whey protein+soy protein |
Primary outcome
lean body mass
Time frame: up to 6 months
At baseline, 3 and 6 months, investigators will use DXA to examine lean body mass and body fat composition
muscular function state
Time frame: up to 6 months
At baseline, 3 and 6 months, investigators will use the Short Physical Performance Battery (SPPB) to test muscular function state
1 secondary outcome
plasma amino acid spectrum, especially branched chain amino acid spectrum
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing protein supplement in people with Healthy, run by Huilian Zhu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhu Hui lian, professor (+86 20 87331811, zhuhl@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lean body mass (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2015.