HealthyNCT06429410
Effects of Milk Powder Intervention on Body Composition and Physical Performance in Middle-aged and Older Adults
A study testing fortified formula milk powder, formula milk powder and regular milk powder in people with Healthy, run by Huilian Zhu.
Trial summary
This study aims to conduct a 24-week intervention involving formula milk powder for middle-aged and elderly individuals, assessing its impact on body composition and physical performance in comparison to interventions using regular milk powder and individuals without intervention. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- fortified formula milk powder, formula milk powder and regular milk powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Jul 2026
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50 years old and older;
- BMI <22kg/m2;
- Calf circumference <33cm in women or <34cm in men, or SARC-F ≥ 4, or SARC-Claf ≥ 11;
- Living in Guangzhou and having no plan to move in the next 6 months;
- Willing to participate in the study.
Who cannot join
- Lactose intolerance;
- Complicated with severe diseases;
- Unable to conduct study procedures;
- Participating in any other intervention studies.
About this study
Official title: Effects of Daily Supplementation With Milk Powder on Body Composition and Physical Performance in Middle-aged and Older Adults: A Randomized Control Trial
This study aims to conduct a 24-week intervention involving formula milk powder for middle-aged and elderly individuals, assessing its impact on body composition and physical performance in comparison to interventions using regular milk powder and individuals without intervention.
- Conditions
- Healthy
- Being tested
- fortified formula milk powder, formula milk powder, regular milk powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortified formula milk powderDietary supplement
Fortified formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, β-hydroxy-β-methylbutyrate, and sodium hyaluronate per day orally for 24 weeks.
formula milk powderDietary supplement
Formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate per day orally for 24 weeks.
regular milk powderDietary supplement
Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.
| Study group | Role | What they receive |
|---|---|---|
| fortified formula milk powder group | Experimental | Fortified formula milk powder is supplemented with whey protein, calcium, vitamin D, colostrum basic protein, β-hydroxy-β-methylbutyrate, and sodium hyaluronate, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day, for a duration of 24 weeks. Receives: Dietary Supplement: fortified formula milk powder |
| formula milk powder group | Experimental | Formula milk powder is supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day, for a duration of 24 weeks. Receives: Dietary Supplement: formula milk powder |
| regular milk powder group | Placebo comparator | Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder. Receives: Dietary Supplement: regular milk powder |
| observation group | No intervention | Participants in the observation group did not receive any supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
lean body mass
At baseline, and 24 weeks, investigators will use DXA to examine lean body mass and fat composition.
Measured: up to 24 weeks
Secondary outcomes (4)
cardiorespiratory fitness
At baseline, and 24 weeks, investigators will use cardiopulmonary exercise testing (CPET) on a cycle ergometer to evaluate cardiorespiratory fitness.
Measured: up to 24 weeks
muscle strength
At baseline, 12, and 24 weeks, investigators will test hand grip to assess muscle strength.
Measured: up to 24 weeks
physical performance
At baseline, 12, and 24 weeks, investigators will test the Short Physical Performance Battery (SPPB) to assess muscular function.
Measured: up to 24 weeks
the levels of blood metabolic markers for bone and muscle
At baseline, and 24 weeks, blood samples will be drawn and serum indexes of bone and muscle metabolism will be test, including myostatin, PINP, CTx, and osteocalcin.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study startMay 2024 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 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
- NCT06429410
- Sponsor's protocol ID
- MN-2024-04
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daily Supplementation With Milk Powder on Body Composition and Physical Performance in Middle-aged and Older Adults: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06429410
- Acronym / sponsor ID
- MN-2024-04
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Huilian ZhuUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 28 May 2024 (actual)
- 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.
This study aims to conduct a 24-week intervention involving formula milk powder for middle-aged and elderly individuals, assessing its impact on body composition and physical performance in comparison to interventions using regular milk powder and individuals without intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fortified formula milk powder group | Experimental | Dietary Supplement: fortified formula milk powderFortified formula milk powder is supplemented with whey protein, calcium, vitamin D, colostrum basic protein, β-hydroxy-β-methylbutyrate, and sodium hyaluronate, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day, for a duration of 24 weeks. |
| formula milk powder group | Experimental | Dietary Supplement: formula milk powderFormula milk powder is supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day, for a duration of 24 weeks. |
| regular milk powder group | Placebo comparator | Dietary Supplement: regular milk powderRegular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder. |
| observation group | No intervention | –Participants in the observation group did not receive any supplementation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 50 years old and older;
- BMI <22kg/m2;
- Calf circumference <33cm in women or <34cm in men, or SARC-F ≥ 4, or SARC-Claf ≥ 11;
- Living in Guangzhou and having no plan to move in the next 6 months;
- Willing to participate in the study.
Key exclusion criteria (4 listed)
- Lactose intolerance;
- Complicated with severe diseases;
- Unable to conduct study procedures;
- Participating in any other intervention studies.
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 |
|---|---|---|
| fortified formula milk powderFortified formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, β-hydroxy-β-methylbutyrate, and sodium hyaluronate per day orally for 24 weeks. | Dietary supplement | fortified formula milk powder group |
| formula milk powderFormula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate per day orally for 24 weeks. | Dietary supplement | formula milk powder group |
| regular milk powderRegular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder. | Dietary supplement | regular milk powder group |
Primary outcome
lean body mass
Time frame: up to 24 weeks
At baseline, and 24 weeks, investigators will use DXA to examine lean body mass and fat composition.
4 secondary outcomes
cardiorespiratory fitness
Time frame: up to 24 weeks
muscle strength
Time frame: up to 24 weeks
physical performance
Time frame: up to 24 weeks
the levels of blood metabolic markers for bone and muscle
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing fortified formula milk powder, formula milk powder and regular milk powder 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 5 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 28 May 2024. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lean body mass (time frame: up to 24 weeks). 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 28 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.