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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Change in Lean Muscle Development
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be female.
- •Be aged 21-
- •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
- •Symptoms of hormonal imbalance.
- •Anyone with a BMI of 18.5 to 30 kg/m
- •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).
Arms & Interventions
Shelf Builder Women's Creatine Powder
Intervention: Shelf Builder Women's Creatine Powder (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Lean Muscle Development
Time Frame: Baseline, Week 4, and Week 8
Self-reported change in lean muscle development assessed via questionnaire
Change in Muscular Endurance
Time Frame: Baseline, Week 4, and Week 8
Self-reported change in muscular endurance assessed via questionnaire
Change in Digestive Comfort
Time Frame: Baseline, Week 4, and Week 8
Self-reported change in digestive comfort assessed via questionnaire
Change in Hair
Time Frame: Baseline, Week 4, and Week 8
Self-reported change in hair, nail, and skin health assessed via questionnaire
Change in Nail
Time Frame: Baseline, Week 4, and Week 8
Self-reported change in hair, nail, and skin health assessed via questionnaire
Change in Skin Health
Time Frame: Baseline, Week 4, and Week 8
Self-reported change in hair, nail, and skin health assessed via questionnaire
Change in Symptoms of Hormonal Imbalance
Time Frame: Baseline, Week 4, and Week 8
Self-reported change in symptoms of hormonal imbalance assessed via questionnaire
Change in Overall Health and Wellness
Time Frame: Baseline, Week 4, and Week 8
Self-reported change in overall health and wellness assessed via questionnaire
Secondary Outcomes
- Perceived Change in Lean Muscle Strength(Baseline, Week 4, and Week 8)
- Perceived Change in Exercise Performance(Baseline, Week 4, and Week 8)
- Perceived Change in Lean Muscle Development(Baseline, Week 4, and Week 8)
- Perceived Change in Hair(Baseline, Week 4, and Week 8)
- Perceived Change in Nail(Baseline, Week 4, and Week 8)
- Perceived Change in Skin Health(Baseline, Week 4, and Week 8)
- Perceived Change in Mood(Baseline, Week 4, and Week 8)
- Perceived Change in Energy Levels(Baseline, Week 4, and Week 8)
- Perceived Change in Mental Clarity(Baseline, Week 4, and Week 8)
- Perceived Change in Digestive Health(Baseline, Week 4, and Week 8)
- Perceived Change in Bloating(Baseline, Week 4, and Week 8)
- Perceived Change in Digestive Comfort(Baseline, Week 4, and Week 8)
- Perceived Change in Muscle Recovery(Baseline, Week 4, and Week 8)