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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06429410
• Other study ID #: MN-2024-04
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• fortified formula milk powder
Fortified formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, ß-hydroxy-ß-methylbutyrate, and sodium hyaluronate per day orally for 24 weeks.
• formula milk powder
Formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate per day orally for 24 weeks.
• regular 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huilian Zhu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lean body mass	At baseline, and 24 weeks, investigators will use DXA to examine lean body mass and fat composition.	up to 24 weeks
Secondary	cardiorespiratory fitness	At baseline, and 24 weeks, investigators will use cardiopulmonary exercise testing (CPET) on a cycle ergometer to evaluate cardiorespiratory fitness.	up to 24 weeks
Secondary	muscle strength	At baseline, 12, and 24 weeks, investigators will test hand grip to assess muscle strength.	up to 24 weeks
Secondary	physical performance	At baseline, 12, and 24 weeks, investigators will test the Short Physical Performance Battery (SPPB) to assess muscular function.	up to 24 weeks
Secondary	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.	up to 24 weeks