Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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 actualizado 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

35

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89101
        • Reclutamiento
        • Citruslabs

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Shelf Builder Women's Creatine Powder
Suplemento dietético: Shelf Builder Women's Creatine Powder
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Lean Muscle Development
Periodo de tiempo: Baseline, Week 4, and Week 8
Self-reported change in lean muscle development assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Muscular Endurance
Periodo de tiempo: Baseline, Week 4, and Week 8
Self-reported change in muscular endurance assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Digestive Comfort
Periodo de tiempo: Baseline, Week 4, and Week 8
Self-reported change in digestive comfort assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Hair
Periodo de tiempo: 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 Nail
Periodo de tiempo: 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
Periodo de tiempo: 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 Symptoms of Hormonal Imbalance
Periodo de tiempo: Baseline, Week 4, and Week 8
Self-reported change in symptoms of hormonal imbalance assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Overall Health and Wellness
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Perceived Change in Lean Muscle Strength
Periodo de tiempo: Baseline, Week 4, and Week 8
Participant-perceived change in lean muscle strength assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Exercise Performance
Periodo de tiempo: Baseline, Week 4, and Week 8
Participant-perceived change in exercise performance assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Lean Muscle Development
Periodo de tiempo: 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
Periodo de tiempo: 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 Nail
Periodo de tiempo: 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 Skin Health
Periodo de tiempo: 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
Periodo de tiempo: Baseline, Week 4, and Week 8
Participant-perceived change in mood assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Energy Levels
Periodo de tiempo: Baseline, Week 4, and Week 8
Participant-perceived change in energy levels assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Mental Clarity
Periodo de tiempo: Baseline, Week 4, and Week 8
Participant-perceived change in mental clarity assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Digestive Health
Periodo de tiempo: Baseline, Week 4, and Week 8
Participant-perceived change in digestive health assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Bloating
Periodo de tiempo: Baseline, Week 4, and Week 8
Participant-perceived change in bloating assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Digestive Comfort
Periodo de tiempo: Baseline, Week 4, and Week 8
Participant-perceived change in digestive comfort assessed via self-reported questionnaire
Baseline, Week 4, and Week 8
Perceived Change in Muscle Recovery
Periodo de tiempo: Baseline, Week 4, and Week 8
Participant-perceived change in muscle recovery assessed via self-reported questionnaire
Baseline, Week 4, and Week 8

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Clean Nutraceuticals

Colaboradores

Citruslabs

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de noviembre de 2026

Finalización del estudio (Estimado)

1 de noviembre de 2026

Fechas de registro del estudio

Enviado por primera vez

11 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de agosto de 2026

Publicado por primera vez (Actual)

14 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 20834
  • legacy-20834

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir