A Clinical Trial to Evaluate the Effects of Peptide Gummies on Markers of Inflammation, Physical Performance, and Recovery
This study will evaluate the effects of Parlay Recover peptide gummies (containing Body Protection Compound BPC-157) on markers of inflammation, physical performance, and recovery in physically active adults. Over an 8-week period, 40 participants will consume two gummies daily and complete questionnaires at Baseline, Week 2, Week 4, Week 6, and Week 8, as well as undergo blood testing at Baseline and Week 8.
The primary objective is to examine changes in inflammatory biomarkers (hs-CRP and IL-6) as measured by blood testing. Secondary objectives include evaluating participants' self-reported perceptions of the product's effects on physical performance and recovery, including aching, stiffness, function, and recovery of muscles and joints.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Nevada
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Las Vegas、Nevada、アメリカ、89101
- Citruslabs
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Be male or female.
- Be aged 18-65.
- Engages in structured physical activity ≥3 times per week, with each session lasting at least 30 minutes, over the past 3 months (e.g., running, gym/strength training, cycling, team sports, fitness classes).
- Within the last 4 weeks, reports post-exercise musculoskeletal symptoms (aching, stiffness, or delayed recovery) at least once per week.
- Willing to maintain current exercise routine throughout the 8-week study (no major changes in frequency, intensity, or new training programs).
- Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- If taking products or supplements that target muscle and joint health, has been consistently taking these for at least 3 months prior to starting the study, and is willing to maintain this routine for the study duration.
- Willing to maintain the same diet and sleep schedule throughout the study duration.
- Resides in the United States.
Exclusion Criteria:
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Use of specialized recovery modalities (e.g., cryotherapy, frequent sports massage, IV nutrition, high-dose recovery supplements) started within the past 8 weeks or expected to be initiated during the trial.
- Acute illness or infection within 14 days prior to Baseline (e.g., fever, flu, COVID-19) or planned surgery during the study.
- History of inflammatory or autoimmune conditions, including but not limited to rheumatoid arthritis, lupus, inflammatory bowel disease (IBD), ankylosing spondylitis, Hashimoto's thyroiditis, or Grave's disease.
- Use of systemic corticosteroids (such as prednisone) within past 8 weeks.
- Recent intra-articular steroid injection within 12 weeks.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
- Anyone who is a heavy drinker (i.e. 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- Anyone with uncontrolled chronic diseases, including but not limited to hypertension (high blood pressure) and diabetes.
- Anyone unwilling to follow the study protocol.
- Anyone with nut sensitivity or allergy.
- Anyone with a history of substance abuse.
- Musculoskeletal injury within the past 8 weeks that required any type of modification in your exercise routine.
- Planning on introducing any new products, prescription medications, or supplements that target muscle health, joint health, or exercise performance for the study duration.
- Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration.
- Anyone with a history of hypotension.
- Anyone who is currently taking antihypertensive medication.
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:処理
- 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 |
|---|---|
|
実験的:Parlay Recover Peptide Gummies
|
All participants receive Parlay Recover peptide gummies containing Body Protection Compound (BPC)-157 (500 µg per serving).
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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 |
|---|---|---|
|
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
時間枠:Baseline and Week 8
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Change in serum hs-CRP levels as measured by blood testing at Quest Diagnostics Clinic
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Baseline and Week 8
|
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Change in Interleukin-6 (IL-6)
時間枠:Baseline and Week 8
|
Change in serum IL-6 levels as measured by blood testing at Quest Diagnostics Clinic
|
Baseline and Week 8
|
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Change in Self-Reported Swelling
時間枠:Baseline, Week 2, Week 4, Week 6, and Week 8
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Change in perceived swelling around muscles and joints as assessed by self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Self-Reported Aching
時間枠:Baseline, Week 2, Week 4, Week 6, and Week 8
|
Change in perceived aching of muscles and joints as assessed by self-reported questionnaire
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Baseline, Week 2, Week 4, Week 6, and Week 8
|
|
Change in Self-Reported Stiffness
時間枠:Baseline, Week 2, Week 4, Week 6, and Week 8
|
Change in perceived stiffness of muscles and joints as assessed by self-reported questionnaire
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Baseline, Week 2, Week 4, Week 6, and Week 8
|
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Change in Self-Reported Muscle Function
時間枠:Baseline, Week 2, Week 4, Week 6, and Week 8
|
Change in perceived function of muscles as assessed by self-reported questionnaire
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Baseline, Week 2, Week 4, Week 6, and Week 8
|
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Change in Self-Reported Recovery
時間枠:Baseline, Week 2, Week 4, Week 6, and Week 8
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Change in perceived recovery of muscles and joints following physical activity as assessed by self-reported questionnaire
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Baseline, Week 2, Week 4, Week 6, and Week 8
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協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
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。