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

NCT06429410 | Not Yet Recruiting

• 1 other identifier: MN-2024-04
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• cardiorespiratory fitness

  up to 24 weeks

• muscle strength

  up to 24 weeks

• physical performance

  up to 24 weeks

• the levels of blood metabolic markers for bone and muscle

  up to 24 weeks

Study Arms (4)

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.

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.

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.

Dietary Supplement: regular milk powder

observation group

NO INTERVENTION

Participants in the observation group did not receive any supplementation.

Interventions

fortified formula milk powder DIETARY_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.

fortified formula milk powder group

formula milk powder DIETARY_SUPPLEMENT

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

formula milk powder group

regular milk powder DIETARY_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.

regular milk powder group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Lactose intolerance;
• Complicated with severe diseases;
• Unable to conduct study procedures;
• Participating in any other intervention studies.

Sponsors & Collaborators

• Huilian Zhu: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 28, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 28, 2024

Record last verified: 2024-05