Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06429410

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Healthy

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. lean body mass

    Time frame: up to 24 weeks

    At baseline, and 24 weeks, investigators will use DXA to examine lean body mass and fat composition.

Secondary outcomes

  1. cardiorespiratory fitness

    Time frame: up to 24 weeks

    At baseline, and 24 weeks, investigators will use cardiopulmonary exercise testing (CPET) on a cycle ergometer to evaluate cardiorespiratory fitness.

  2. muscle strength

    Time frame: up to 24 weeks

    At baseline, 12, and 24 weeks, investigators will test hand grip to assess muscle strength.

  3. physical performance

    Time frame: up to 24 weeks

    At baseline, 12, and 24 weeks, investigators will test the Short Physical Performance Battery (SPPB) to assess muscular function.

  4. the levels of blood metabolic markers for bone and muscle

    Time frame: up to 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Huilian Zhu

Other

Registry information

Official study title

Effects of Daily Supplementation With Milk Powder on Body Composition and Physical Performance in Middle-aged and Older Adults: A Randomized Control Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 28, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.