A Clinical Trial to Evaluate the Effects of a Powder Supplement in Supporting Lean Muscle Development, Hormone-Related Wellness, Digestive Comfort, Dermatologic Health, and Overall Wellness
11 de agosto de 2026 atualizado por: Clean Nutraceuticals
This study will evaluate the effects of Clean Nutra's Shelf Builder Women's Creatine Powder on lean muscle development, hormone-related wellness, digestive comfort, dermatological health, and overall wellness. The study is a single-arm, open-label, virtual trial in which all 35 enrolled participants will use the test product once daily for eight weeks.
Participants will complete self-reported questionnaires at Baseline and at the end of Week 4 and Week 8 to assess changes in lean muscle development, muscular endurance, hormone-related wellness, digestive comfort, hair/nail/skin health, and overall wellness.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
35
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Patrick Renner
- E-mail: hello@citruslabs.com
Locais de estudo
-
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89101
- Recrutamento
- Citruslabs
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Be female.
- Be aged 21-45.
- Engages in structured physical activity ≥3 times per week, with each session lasting at least 30 minutes, (e.g., running, gym/strength training, cycling, team sports, fitness classes).
- Anyone with a menstrual cycle between 24-38 days.
- Anyone who has experienced concerns with at least two of the following, twice per week, over the past four weeks: Hair, skin, and nail health
- Bloating
- Symptoms of hormonal imbalance.
- Anyone with a BMI of 18.5 to 30 kg/m2.
- Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- If taking medications, other supplements, or herbal remedies targeted at lean muscle development, muscular endurance, digestive comfort, hormonal balance, or dermatological health, has been consistently taking for at least three months prior to starting the study, and is willing to maintain this routine for the study duration.
- Anyone who is willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial.
- 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 mental health disorders.
- Anyone with a known history of severe digestive disorders like acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, or gastrointestinal tract surgeries.
- Planning on introducing any products or any new forms of prescription medication or supplements that target lean muscle development, muscular endurance, digestive comfort, hormonal balance, or dermatological health for the study duration.
- Anyone who has been diagnosed with kidney disease and/or has previously or is currently taking diuretics or kidney medications.
- Anyone who has previously or is currently taking any hormone therapies.
- Anyone who is currently taking medications or supplements that contain zinc or iron.
- Anyone with any allergies or sensitivities to fish, eggs, or any of the study product ingredients.
- Anyone currently consuming products with creatine.
- Anyone diagnosed with a thyroid-related condition.
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- Anyone who has a history of serious illness in the last three months.
- Anyone who has planned surgery during the study period.
- Anyone with a history of substance abuse.
- Anyone who is currently a smoker or has been a smoker in the past 3 months.
- Anyone who has stopped or started using hormonal birth control in the past 2 months.
- Anyone who is vegan and/or does not consume animal products for any reason.
- Anyone currently taking a weight loss medication, including but not limited to Wegovy, Mounjaro, and Ozempic.
- Currently undergoing hair treatment or using other hair growth/thickening products.
- Currently taking any prescription medication for hair loss.
- Anyone with any conditions that affect the hair or scalp (e.g., alopecia areata).
- Anyone who drinks heavily (8 or more alcoholic drinks per week).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Shelf Builder Women's Creatine Powder
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All participants take one scoop (9 g) of Clean Nutra Shelf Builder Women's Creatine Powder mixed in 8 oz of cold water once daily with the first meal of the day for eight weeks.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Lean Muscle Development
Prazo: Baseline, Week 4, and Week 8
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Self-reported change in lean muscle development assessed via questionnaire
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Baseline, Week 4, and Week 8
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Change in Muscular Endurance
Prazo: Baseline, Week 4, and Week 8
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Self-reported change in muscular endurance assessed via questionnaire
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Baseline, Week 4, and Week 8
|
|
Change in Digestive Comfort
Prazo: Baseline, Week 4, and Week 8
|
Self-reported change in digestive comfort assessed via questionnaire
|
Baseline, Week 4, and Week 8
|
|
Change in Hair
Prazo: Baseline, Week 4, and Week 8
|
Self-reported change in hair, nail, and skin health assessed via questionnaire
|
Baseline, Week 4, and Week 8
|
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Change in Nail
Prazo: Baseline, Week 4, and Week 8
|
Self-reported change in hair, nail, and skin health assessed via questionnaire
|
Baseline, Week 4, and Week 8
|
|
Change in Skin Health
Prazo: Baseline, Week 4, and Week 8
|
Self-reported change in hair, nail, and skin health assessed via questionnaire
|
Baseline, Week 4, and Week 8
|
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Change in Symptoms of Hormonal Imbalance
Prazo: Baseline, Week 4, and Week 8
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Self-reported change in symptoms of hormonal imbalance assessed via questionnaire
|
Baseline, Week 4, and Week 8
|
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Change in Overall Health and Wellness
Prazo: Baseline, Week 4, and Week 8
|
Self-reported change in overall health and wellness assessed via questionnaire
|
Baseline, Week 4, and Week 8
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Perceived Change in Lean Muscle Strength
Prazo: Baseline, Week 4, and Week 8
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Participant-perceived change in lean muscle strength assessed via self-reported questionnaire
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Baseline, Week 4, and Week 8
|
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Perceived Change in Exercise Performance
Prazo: Baseline, Week 4, and Week 8
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Participant-perceived change in exercise performance assessed via self-reported questionnaire
|
Baseline, Week 4, and Week 8
|
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Perceived Change in Lean Muscle Development
Prazo: Baseline, Week 4, and Week 8
|
Participant-perceived change in lean muscle development assessed via self-reported questionnaire
|
Baseline, Week 4, and Week 8
|
|
Perceived Change in Hair
Prazo: Baseline, Week 4, and Week 8
|
Participant-perceived change in hair, nail, and skin health assessed via self-reported questionnaire
|
Baseline, Week 4, and Week 8
|
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Perceived Change in Nail
Prazo: Baseline, Week 4, and Week 8
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Participant-perceived change in hair, nail, and skin health assessed via self-reported questionnaire
|
Baseline, Week 4, and Week 8
|
|
Perceived Change in Skin Health
Prazo: Baseline, Week 4, and Week 8
|
Participant-perceived change in hair, nail, and skin health assessed via self-reported questionnaire
|
Baseline, Week 4, and Week 8
|
|
Perceived Change in Mood
Prazo: Baseline, Week 4, and Week 8
|
Participant-perceived change in mood assessed via self-reported questionnaire
|
Baseline, Week 4, and Week 8
|
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Perceived Change in Energy Levels
Prazo: Baseline, Week 4, and Week 8
|
Participant-perceived change in energy levels assessed via self-reported questionnaire
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Baseline, Week 4, and Week 8
|
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Perceived Change in Mental Clarity
Prazo: Baseline, Week 4, and Week 8
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Participant-perceived change in mental clarity assessed via self-reported questionnaire
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Baseline, Week 4, and Week 8
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Perceived Change in Digestive Health
Prazo: Baseline, Week 4, and Week 8
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Participant-perceived change in digestive health assessed via self-reported questionnaire
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Baseline, Week 4, and Week 8
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Perceived Change in Bloating
Prazo: Baseline, Week 4, and Week 8
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Participant-perceived change in bloating assessed via self-reported questionnaire
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Baseline, Week 4, and Week 8
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Perceived Change in Digestive Comfort
Prazo: Baseline, Week 4, and Week 8
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Participant-perceived change in digestive comfort assessed via self-reported questionnaire
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Baseline, Week 4, and Week 8
|
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Perceived Change in Muscle Recovery
Prazo: Baseline, Week 4, and Week 8
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Participant-perceived change in muscle recovery assessed via self-reported questionnaire
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Baseline, Week 4, and Week 8
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de novembro de 2026
Conclusão do estudo (Estimado)
1 de novembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
11 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de agosto de 2026
Primeira postagem (Real)
14 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 20834
- legacy-20834
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .