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

Huilian Zhu

Status: Not yet enrolling

Conditions: Healthy

Treatments: Dietary Supplement: fortified formula milk powder; Dietary Supplement: regular milk powder; Dietary Supplement: formula milk powder

Study type: Interventional

Funder types: Other

Identifiers

NCT06429410

MN-2024-04

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 4 patient groups, including a placebo group

fortified formula milk powder group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: fortified formula milk powder

formula milk powder group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: formula milk powder

regular milk powder group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: regular milk powder

observation group

No Intervention group

Description:

Participants in the observation group did not receive any supplementation.