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Completed

NCT Number: NCT07828340

Functional Evaluation of Shelf-Stable Dairy Products for the Promotion of Muscle Mass, Strength, and Physical Performance in Human Subjects.

This study aims to evaluate the effects of daily supplementation with room-temperature high-protein dairy products over six consecutive weeks, without altering the subjects' existing exercise habits, on muscle mass, muscle strength, and functional exercise performance in young adults aged 18-45. Furthermore, this study serves as a functional evaluation baseline for the application of room-temperature dairy products in sports nutrition.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan Sport University

Taoyuan, Taiwan

About this study

The relationship between protein intake and muscle adaptation is well-established; however, many physically active young and middle-aged adults fail to meet the optimal protein recommendations for maximizing muscle gains. Currently, the impact of daily supplementation with shelf-stable high-protein dairy products on muscle mass, strength, and exercise performance in a real-world training environment requires further evaluation through ecologically valid research designs.

This study recruited physically active adults aged 18 to 45 to participate in a 6-week high-protein dairy intervention. Utilizing a pre-, mid-, and post-test design, the study integrated subjective perception questionnaires, body composition analysis, and functional mobility tests to assess changes in physical status, functional performance, and self-reported outcomes. By employing a multi-dimensional assessment, this research aims to examine the practical feasibility and value of such products in real-life scenarios, serving as a reference for sports nutrition applications and future empirical studies.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18-45 years,Male.
  • Engages in exercise at least 3 times per week, with a preference for including resistance training at least once per week
  • Exercises for no less than 30 minutes per session, reaching an intensity characterized by shortness of breath, sweating, or a heart rate of approximately 130 beats per minute (bpm) or higher.
  • Self-perceived ability to tolerate fatigue and exhaustion resulting from high-intensity exercise.

Exclusion criteria

  • Lactose intolerance or allergy to dairy products.
  • Habitual smoking or current smoker.
  • Diagnosed medical conditions: Physician-diagnosed cardiovascular disease, hypertension, metabolic disease, asthma, or renal (kidney) disease.
  • Body Mass Index (BMI):27≥ kg/m².
  • Recent musculoskeletal/neuromuscular injury: Musculoskeletal or neuromuscular injury within the past 6 months that prevents normal participation in exercise.

Treatment and study plan

Dairy intervention

Dietary Supplement

An 6-week high-protein, high-calcium, and vitamin D-enriched dairy intervention.

Primary outcomes

  1. Questionnaire-based subjective assessment

    Time frame: The testing time points are set as follows: before the intervention, after 3 weeks of intervention, and after 6 weeks of intervention.

    Participants' subjective physical sensations, post-exercise fatigue, body image perceptions, and product use experience will be assessed using individual items from a self-administered questionnaire developed for this study. Questionnaire items may include Likert-scale items, categorical response options, and open-ended responses. Likert-scale items will be reported separately according to their original response scale, with the minimum and maximum values specified for each item. Categorical items will be reported as the number and percentage of participants selecting each response option. Open-ended responses will be summarized descriptively. No overall questionnaire total score will be calculated.

  2. Handgrip Strength Test

    Time frame: The testing time points are set as follows: before the intervention, after 3 weeks of intervention, and after 6 weeks of intervention.

    Participants performed the test in a standing position with their arms naturally hanging down. They held the handgrip dynamometer with one hand and applied maximal force continuously for at least 3 seconds. Each hand was tested three times, and the best value was recorded.

  3. 5-Repetition Sit-to-Stand Test (5STS)

    Time frame: The testing time points are set as follows: before the intervention, and after 6 weeks of intervention.

    Participants performed five consecutive sit-to-stand repetitions as quickly as possible from a armless chair with arms crossed over the chest, and the total completion time (in seconds) was measured using a digital timer.

  4. 30-Second Sit-to-Stand Test (30STS)

    Time frame: The testing time points are set as follows: before the intervention, and after 6 weeks of intervention.

    Participants performed as many full sit-to-stand repetitions as possible within 30 seconds from a standard armless chair with arms crossed over the chest, and the total number of completed repetitions was recorded.

  5. Isometric Mid-Thigh Pull Test (IMTP)

    Time frame: The testing time points are set as follows: before the intervention, and after 6 weeks of intervention.

    Participants performed three maximum isometric effort pulls on a fixed bar over a force plate at standardized knee and hip angles for 5 seconds per trial, separated by ≥1-minute rest intervals, with the highest peak force recorded for analysis.

  6. Countermovement Jump Test (CMJ)

    Time frame: The testing time points are set as follows: before the intervention, and after 6 weeks of intervention.

    Participants performed three vertical countermovement jumps on a force plate with hands fixed on the hips and 60-second rest intervals between trials, with the maximum jump height selected for final analysis.

  7. Maximal Oxygen Consumption Test (VO² max)

    Time frame: The testing time points are set as follows: before the intervention, and after 6 weeks of intervention.

    Participants performed an incremental exercise protocol on a stationary cycle ergometer starting at 25W and increasing by 15W every 2 minutes at a cadence of 70 rpm until exhaustion, while heart rate and subjective rating of perceived exertion (RPE) were continuously monitored.

  8. Time-to-Exhaustion Endurance Capacity Test (TTE)

    Time frame: [Time Frame: The testing time points are set as follows: before the intervention, and after 6 weeks of intervention.]

    Participants exercised at a target intensity based on their VO² max test until reaching defined volitional exhaustion criteria, with total exercise duration and mechanical work output recorded as endurance capacity indicators.

Secondary outcomes

  1. Body weight

    Time frame: The testing time points are set as follows: before the intervention, after 3 weeks of intervention, and after 6 weeks of intervention.

    Body weight will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported in kilograms (kg).

  2. Body mass index

    Time frame: The testing time points are set as follows: before the intervention, after 3 weeks of intervention, and after 6 weeks of intervention.

    Body mass index (BMI) will be calculated from body weight and height and reported in kilograms per square meter (kg/m^2).

  3. Body fat percentage

    Time frame: The testing time points are set as follows: before the intervention, after 3 weeks of intervention, and after 6 weeks of intervention.

    Body fat percentage will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported as a percentage (%).

  4. Fat mass

    Time frame: The testing time points are set as follows: before the intervention, after 3 weeks of intervention, and after 6 weeks of intervention.

    Fat mass will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported in kilograms (kg).

  5. Skeletal muscle mass

    Time frame: The testing time points are set as follows: before the intervention, after 3 weeks of intervention, and after 6 weeks of intervention.

    Skeletal muscle mass will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported in kilograms (kg).

  6. Skeletal muscle percentage

    Time frame: The testing time points are set as follows: before the intervention, after 3 weeks of intervention, and after 6 weeks of intervention.

    Skeletal muscle percentage will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported as a percentage (%).

  7. Waist-to-hip ratio

    Time frame: The testing time points are set as follows: before the intervention, after 3 weeks of intervention, and after 6 weeks of intervention.

    Waist-to-hip ratio will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported as a ratio.

  8. Dual-Energy X-ray Absorptiometry (DXA)

    Time frame: The testing time points are set as follows: before the intervention, and after 6 weeks of intervention.

    Whole-body composition, as well as bone mineral density (BMD) of the AP lumbar spine, bilateral femurs, and total body, will be measured using a dual-energy X-ray absorptiometry scanner (Lunar iDXA, GE Healthcare).

Sponsors and collaborators

Lead sponsor

National Taiwan Sport University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

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.

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