Healthy VolunteersNCT07828340
Functional Evaluation of Shelf-Stable Dairy Products for the Promotion of Muscle Mass, Strength, and Physical Performance in Human Subjects.
A study testing Dairy intervention in people with Healthy Volunteers, run by National Taiwan Sport University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dairy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jun 2026to 29 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- Dairy intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy interventionDietary supplement
An 6-week high-protein, high-calcium, and vitamin D-enriched dairy intervention.
| Study group | Role | What they receive |
|---|---|---|
| Dairy intervention group | Experimental | An 6-week high-protein, high-calcium, and vitamin D-enriched dairy intervention. Receives: Dietary Supplement: Dairy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: [Time Frame: The testing time points are set as follows: before the intervention, and after 6 weeks of intervention.]
Secondary outcomes (8)
Body weight
Body weight will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported in kilograms (kg).
Measured: 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
Body mass index (BMI) will be calculated from body weight and height and reported in kilograms per square meter (kg/m^2).
Measured: 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
Body fat percentage will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported as a percentage (%).
Measured: The testing time points are set as follows: before the intervention, after 3 weeks of intervention, and after 6 weeks of intervention.
Fat mass
Fat mass will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported in kilograms (kg).
Measured: 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
Skeletal muscle mass will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported in kilograms (kg).
Measured: 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
Skeletal muscle percentage will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported as a percentage (%).
Measured: 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
Waist-to-hip ratio will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported as a ratio.
Measured: The testing time points are set as follows: before the intervention, after 3 weeks of intervention, and after 6 weeks of intervention.
Dual-Energy X-ray Absorptiometry (DXA)
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).
Measured: The testing time points are set as follows: before the intervention, and after 6 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start8 Jun 2026
- Primary completion29 Jul 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Ju Hsu, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828340
- Sponsor's protocol ID
- NTSUIRB-115-094
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Evaluation of Shelf-Stable Dairy Products for the Promotion of Muscle Mass, Strength, and Physical Performance in Human Subjects.
- ClinicalTrials.gov ID
- NCT07828340
- Acronym / sponsor ID
- NTSUIRB-115-094
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dairy intervention group | Experimental | Dietary Supplement: Dairy interventionAn 6-week high-protein, high-calcium, and vitamin D-enriched dairy intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dairy interventionAn 6-week high-protein, high-calcium, and vitamin D-enriched dairy intervention. | Dietary supplement | Dairy intervention group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
8 secondary outcomes
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 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 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.
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.
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 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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy intervention in people with Healthy Volunteers, run by National Taiwan Sport University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.