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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. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

35

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89101
        • Rekruttering
        • Citruslabs

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Shelf Builder Women's Creatine Powder
Kosttilskudd: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Lean Muscle Development
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, Week 4, and Week 8
Self-reported change in digestive comfort assessed via questionnaire
Baseline, Week 4, and Week 8
Change in Hair
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, Week 4, and Week 8
Self-reported change in overall health and wellness assessed via questionnaire
Baseline, Week 4, and Week 8

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Perceived Change in Lean Muscle Strength
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, Week 4, and Week 8
Participant-perceived change in muscle recovery assessed via self-reported questionnaire
Baseline, Week 4, and Week 8

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Clean Nutraceuticals

Samarbeidspartnere

Citruslabs

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. november 2026

Studiet fullført (Antatt)

1. november 2026

Datoer for studieregistrering

Først innsendt

11. august 2026

Først innsendt som oppfylte QC-kriteriene

11. august 2026

Først lagt ut (Faktiske)

14. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 20834
  • legacy-20834

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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