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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: fortified formula milk powder; Dietary supplement: formula milk powder; Dietary supplement: regular milk powder

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; Formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate per day orally for 24 weeks.
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; Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.
No Intervention: observation group; Participants in the observation group did not receive any supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
muscle strength	At baseline, 12, and 24 weeks, investigators will test hand grip to assess muscle strength.	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.	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.	up to 24 weeks

Collaborators and Investigators

• Sponsor: Huilian Zhu

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MN-2024-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No