Healthy
Conditions
Brief 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.
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.
Sponsors
Huilian Zhu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Lactose intolerance; * Complicated with severe diseases; * Unable to conduct study procedures; * Participating in any other intervention studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lean body mass | up to 24 weeks | At baseline, and 24 weeks, investigators will use DXA to examine lean body mass and fat composition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cardiorespiratory fitness | up to 24 weeks | At baseline, and 24 weeks, investigators will use cardiopulmonary exercise testing (CPET) on a cycle ergometer to evaluate cardiorespiratory fitness. |
| muscle strength | up to 24 weeks | At baseline, 12, and 24 weeks, investigators will test hand grip to assess muscle strength. |
| physical performance | up to 24 weeks | At baseline, 12, and 24 weeks, investigators will test the Short Physical Performance Battery (SPPB) to assess muscular function. |
| the levels of blood metabolic markers for bone and muscle | up to 24 weeks | 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. |
Outcome results
None listed