NCT07598786

Brief Summary

This study evaluates the practical feasibility and potential effects of an 8-week dairy product intervention in physically active adults aged 18-39 years. Participants will consume a dairy product enriched with high protein, calcium, and vitamin D under real-life conditions. Assessments will be conducted before the intervention, after 4 weeks, and after 8 weeks, including subjective perception questionnaires, body composition analysis, and functional physical performance tests. The study aims to examine changes in physical status, functional capacity, and user experience during continuous product use.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable healthy-volunteers

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 8, 2026

Last Update Submit

May 16, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 4 weeks of intervention, and after 8 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 4 weeks of intervention, and after 8 weeks of intervention.

  • Push-Up Test

    Participants performed the push-up test on an exercise mat, with both hands placed shoulder-width apart to support the body. The fingers pointed forward, the elbows were fully extended, and the feet were approximately 10 cm apart. Male participants performed the test with support from the feet, whereas female participants performed the modified version with support from the knees. Participants were instructed to complete as many repetitions as possible while maintaining proper form. The test was terminated when the movement no longer met the required standard or could not be continued.

    The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.

  • Curl-Up Test

    Participants lay supine on an exercise mat with both knees bent and feet flat on the floor. They performed curl-ups according to a fixed rhythm. Participants were instructed to complete as many repetitions as possible while maintaining proper form. When a participant failed to perform the movement correctly once, the examiner raised one hand and indicated the number "one." If the participant failed a second time, the examiner indicated the number "two." The test was terminated when the participant failed twice or completed 75 repetitions. If the participant was unable to maintain the required rhythm or perform the movement according to the standard criteria, the test was stopped.

    The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.

  • Three-Minute Progressive Step-in-Place Test

    Participants performed step-in-place movements according to the instructions and raised their knees to the designated height. The test lasted for 3 minutes, with an initial cadence of 96 beats per minute, which was progressively increased each minute. During the test, heart rate was recorded using a heart rate monitor before exercise, during exercise, and during the post-exercise recovery period.

    The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.

Secondary Outcomes (7)

  • Body weight

    The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.

  • Body mass index

    The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.

  • Body fat percentage

    The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.

  • Fat mass

    The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.

  • Skeletal muscle mass

    The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.

  • +2 more secondary outcomes

Study Arms (1)

Dairy intervention group

EXPERIMENTAL

An 8-week high-protein, high-calcium, and vitamin D-enriched dairy intervention.

Dietary Supplement: Dairy intervention

Interventions

Dairy interventionDIETARY_SUPPLEMENT

An 8-week high-protein, high-calcium, and vitamin D-enriched dairy intervention.

Dairy intervention group

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-39 years.
  • Have regular exercise habits, defined as exercising at least three times per week, with each session lasting no less than 30 minutes. Exercise intensity should reach a heart rate of approximately ≥130 beats/min or a perceived intensity characterized by noticeable breathlessness and sweating.
  • Preferably, at least one exercise session per week should include resistance training.
  • Participants must be able to consume dairy products and have no lactose intolerance.

You may not qualify if:

  • Individuals with lactose intolerance or an allergy to dairy products.
  • Individuals who are pregnant, planning to become pregnant, or breastfeeding.
  • Individuals with a smoking habit.
  • Individuals diagnosed by a physician with cardiovascular disease, hypertension, metabolic disease, asthma, or kidney disease.
  • Individuals with a body mass index (BMI) ≥27.
  • Individuals who have experienced limb or neuromuscular exercise-related injuries within the past 6 months that prevent them from engaging in regular exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yi-Ju Hsu, Professor

    National Taiwan Sport University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

May 8, 2026

First Posted

May 20, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05