跳至主要内容
临床试验/NCT07828340
NCT07828340已完成不适用

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

National Taiwan Sport University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Questionnaire-based subjective assessment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Dairy intervention group

Experimental

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

干预措施: Dairy intervention (Dietary Supplement)

结局指标

主要结局

Questionnaire-based subjective assessment

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: [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.

次要结局

  • 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.)
  • Skeletal muscle percentage(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(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)(The testing time points are set as follows: before the intervention, and after 6 weeks of intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi-Ju Hsu

Professor

National Taiwan Sport University

研究点 (1)

Loading locations...

相似试验