ClinicalTrials.gg
Not yet recruitingNCT06429410Updated May 28, 2024

Effects of Milk Powder Intervention on Body Composition and Physical Performance in Middle-aged and Older Adults

An interventional study of fortified formula milk powder and formula milk powder in Healthy, sponsored by Huilian Zhu. Not yet recruiting. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by Huilian Zhu · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Huilian Zhu is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 50 years old and older;
  • \<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.

Exclusion criteria

Exclusion Criteria:

  • Lactose intolerance;
  • Complicated with severe diseases;
  • Unable to conduct study procedures;
  • Participating in any other intervention studies.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    fortified formula milk powder group

    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.

    Dietary Supplement: fortified formula milk powder

  • Experimental
    formula milk powder group

    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.

    Dietary Supplement: formula milk powder

  • Placebo comparator
    regular milk powder group

    Regular 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

  • No intervention
    observation group

    Participants in the observation group did not receive any supplementation.

Interventions

  • Dietary supplementfortified formula milk powder

    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.

  • Dietary supplementformula milk powder

    Formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate per day orally for 24 weeks.

  • Dietary supplementregular milk powder

    Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.

06

What researchers measure

Primary outcomes

  1. lean body mass

    At baseline, and 24 weeks, investigators will use DXA to examine lean body mass and fat composition.

    Time frame: up to 24 weeks

Secondary outcomes

  1. cardiorespiratory fitness

    At baseline, and 24 weeks, investigators will use cardiopulmonary exercise testing (CPET) on a cycle ergometer to evaluate cardiorespiratory fitness.

    Time frame: up to 24 weeks

  2. muscle strength

    At baseline, 12, and 24 weeks, investigators will test hand grip to assess muscle strength.

    Time frame: up to 24 weeks

  3. physical performance

    At baseline, 12, and 24 weeks, investigators will test the Short Physical Performance Battery (SPPB) to assess muscular function.

    Time frame: up to 24 weeks

  4. 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.

    Time frame: up to 24 weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2024; primary completion for Jul 2026, 26 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2024
First posted
May 28, 2024
StartEst.
May 2024
Primary completionEst.
Jul 2026
CompletionEst.
Jul 2026
Last update
May 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06429410
Lead sponsor
Huilian Zhu
Responsible party
Huilian Zhu (Professor, Sun Yat-sen University) — Sponsor-investigator
First posted
May 28, 2024
Start date
May 2024 (estimated)
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
May 28, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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