- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07766395
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patrick Renner
- Email: hello@citruslabs.com
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89101
- Recruiting
- Citruslabs
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Lean Muscle Development
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, Week 4, and Week 8
|
Self-reported change in digestive comfort assessed via questionnaire
|
Baseline, Week 4, and Week 8
|
|
Change in Hair
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, Week 4, and Week 8
|
Self-reported change in overall health and wellness assessed via questionnaire
|
Baseline, Week 4, and Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Change in Lean Muscle Strength
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, Week 4, and Week 8
|
Participant-perceived change in muscle recovery assessed via self-reported questionnaire
|
Baseline, Week 4, and Week 8
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20834
- legacy-20834
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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