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- Ensaio Clínico NCT07752381
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Nevada
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Las Vegas, Nevada, Estados Unidos, 89101
- Citruslabs
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Parlay Recover Peptide Gummies
|
All participants receive Parlay Recover peptide gummies containing Body Protection Compound (BPC)-157 (500 µg per serving).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Prazo: Baseline and Week 8
|
Change in serum hs-CRP levels as measured by blood testing at Quest Diagnostics Clinic
|
Baseline and Week 8
|
|
Change in Interleukin-6 (IL-6)
Prazo: Baseline and Week 8
|
Change in serum IL-6 levels as measured by blood testing at Quest Diagnostics Clinic
|
Baseline and Week 8
|
|
Change in Self-Reported Swelling
Prazo: Baseline, Week 2, Week 4, Week 6, and Week 8
|
Change in perceived swelling around muscles and joints as assessed by self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Self-Reported Aching
Prazo: Baseline, Week 2, Week 4, Week 6, and Week 8
|
Change in perceived aching of muscles and joints as assessed by self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
|
Change in Self-Reported Stiffness
Prazo: Baseline, Week 2, Week 4, Week 6, and Week 8
|
Change in perceived stiffness of muscles and joints as assessed by self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
|
Change in Self-Reported Muscle Function
Prazo: Baseline, Week 2, Week 4, Week 6, and Week 8
|
Change in perceived function of muscles as assessed by self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
|
Change in Self-Reported Recovery
Prazo: Baseline, Week 2, Week 4, Week 6, and Week 8
|
Change in perceived recovery of muscles and joints following physical activity as assessed by self-reported questionnaire
|
Baseline, Week 2, Week 4, Week 6, and Week 8
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20819 (Fred Hutch/University of Washington Cancer Consortium)
- legacy-20819
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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