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

NCT ID: NCT06429410

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

fortified formula milk powder

Intervention Type 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.

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.

Group Type EXPERIMENTAL

formula milk powder

Intervention Type DIETARY_SUPPLEMENT

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 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.

Group Type PLACEBO_COMPARATOR

regular milk powder

Intervention Type 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.

observation group

Participants in the observation group did not receive any supplementation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Huilian Zhu

OTHER

Sponsor Role lead

Responsible Party

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Huilian Zhu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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MN-2024-04

Identifier Type: -

Identifier Source: org_study_id

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