Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

35

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89101
        • Reclutamento
        • Citruslabs

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Shelf Builder Women's Creatine Powder
Integratore alimentare: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Lean Muscle Development
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, Week 4, and Week 8
Self-reported change in digestive comfort assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Hair
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, Week 4, and Week 8
Self-reported change in overall health and wellness assessed via questionnaire
Baseline, Week 4, and Week 8

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Perceived Change in Lean Muscle Strength
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, Week 4, and Week 8
Participant-perceived change in muscle recovery assessed via self-reported questionnaire
Baseline, Week 4, and Week 8

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Clean Nutraceuticals

Collaboratori

Citruslabs

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 novembre 2026

Date di iscrizione allo studio

Primo inviato

11 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 agosto 2026

Primo Inserito (Effettivo)

14 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 20834
  • legacy-20834

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi