Development and Strategic Research of Practical Applications in Sports Nutrition
調査の概要
詳細な説明
With increasing awareness of regular exercise and health promotion, sports nutrition products have become a common supplementation choice among physically active populations. In real-world settings, these products are typically consumed continuously as part of daily life. Evaluating changes in physical status, functional physical performance, and users' subjective perceptions during actual use therefore requires research designs that closely reflect everyday living conditions.
This study recruits physically active adults aged 18-39 years and conducts an 8-week intervention involving the consumption of a dairy product enriched with high protein, calcium, and vitamin D. A pre-, mid-, and post-intervention design is employed, integrating subjective perception questionnaires, body composition analysis, and functional physical performance assessments to evaluate changes in physical status, functional capacity, and subjective experiences throughout the intervention period. Through this multi-dimensional evaluation approach, the study aims to examine the practical feasibility and application value of the product in real-life settings and to provide evidence to support sports nutrition practice and future research.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Yi-Ju Hsu
- 電話番号：+886-3-328-3201 #2430
- メール：ruby780202@ntsu.edu.tw
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Dairy intervention group
An 8-week high-protein, high-calcium, and vitamin D-enriched dairy intervention.
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An 8-week high-protein, high-calcium, and vitamin D-enriched dairy intervention.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Questionnaire-based subjective assessment
時間枠：The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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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.
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The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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Handgrip Strength Test
時間枠：The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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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.
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The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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Push-Up Test
時間枠：The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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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.
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The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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Curl-Up Test
時間枠：The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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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.
|
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Three-Minute Progressive Step-in-Place Test
時間枠：The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body weight
時間枠：The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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Body weight will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported in kilograms (kg).
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The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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Body mass index
時間枠：The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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Body mass index (BMI) will be calculated from body weight and height and reported in kilograms per square meter (kg/m^2).
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The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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Body fat percentage
時間枠：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 will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported as a percentage (%).
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The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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Fat mass
時間枠：The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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Fat mass will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported in kilograms (kg).
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The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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Skeletal muscle mass
時間枠：The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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Skeletal muscle mass will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported in kilograms (kg).
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The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
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Skeletal muscle percentage
時間枠：The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 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 (%).
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The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
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Waist-to-hip ratio
時間枠：The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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Waist-to-hip ratio will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported as a ratio.
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The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
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協力者と研究者
捜査官
- 主任研究者：Yi-Ju Hsu, Professor、National Taiwan Sport University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- NTSUIRB-115-010
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Dairy interventionの臨床試験
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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University of MichiganNational Institute on Drug Abuse (NIDA)完了
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University of PittsburghCenters for Disease Control and Prevention募集暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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Munich Municipal HospitalTechnical University of Munich; University of Regensburgわからない