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

NCT07828340 | Completed

• 1 other identifier: NTSUIRB-115-094
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• Questionnaire-based subjective assessment

  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.

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

• Handgrip Strength Test

  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.

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

• 5-Repetition Sit-to-Stand Test (5STS)

  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.

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

• 30-Second Sit-to-Stand Test (30STS)

  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.

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

• Isometric Mid-Thigh Pull Test (IMTP)

  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.

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

• Countermovement Jump Test (CMJ)

  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.

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

• Maximal Oxygen Consumption Test (VO² max)

  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.

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

• Time-to-Exhaustion Endurance Capacity Test (TTE)

  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.

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

Secondary Outcomes (8)

• Body weight

  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

  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

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

• Fat mass

  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

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

Study Arms (1)

Dairy intervention group

EXPERIMENTAL

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

Dietary Supplement: Dairy intervention

Interventions

Dairy intervention DIETARY_SUPPLEMENT

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

Dairy intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan Sport University: lead

Study Sites (1)

National Taiwan Sport University

Taoyuan, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: June 8, 2026
• Primary Completion: July 29, 2026
• Study Completion: July 29, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

TW (1)