The goal of this clinical trial is to investigate the efficacy of BioCopper1®, Restore Cu1, and Grow + Restore Cu1 on grey hair, hair growth, and/or skin improvements in healthy adults. The main question it aims to answer is: what is the change from baseline to Day 168 in percentage of grey hair between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by HairMetrix? Researchers will compare the investigational products to a placebo to determine their effectiveness. Participants will be asked to:
* Have their blood pressure, heart rate, height, and weight measurements taken * Have their blood samples collected * Complete questionnaires and a study diary * Be assessed using the VISIA imaging system, Corneometer, and Cutometer * Consume BioCopper1®, Restore Cu1, Grow + Restore Cu1, or placebo
Males and females aged 18 to 45 years, inclusive
Stable body weight defined as a <5% change in body weight in the three months prior to baseline as assessed by the Qualified Investigator (QI)
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Nexplanon)
Double-barrier method
Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, or intolerance preventing consumption of investigational product, comparator, or placebo ingredients
Infections or dermatological conditions of the scalp and/or face
Significant life or traumatic event that may be associated with acute hair loss (e.g., postpartum, job loss, death of a family member), as assessed by a QI
Parallel
BioCopper1
Dietary supplementStarting the day following their baseline B visit (Day 1), participants will be instructed to take one dose (one capsule) with water twice daily with or without food until the day prior to their end of study visit (Day 167). Participants will be instructed to not take any zinc or N-acetylcysteine supplements within 4 hours of dose.
Restore Cu1
Dietary supplementStarting the day following their baseline B visit (Day 1), participants will be instructed to take one dose (one capsule) with water twice daily with or without food until the day prior to their end of study visit (Day 167). Participants will be instructed to not take any zinc or N-acetylcysteine supplements within 4 hours of dose.
Grow + Restore Cu1
Dietary supplementStarting the day following their baseline B visit (Day 1), participants will be instructed to take one dose (one capsule) with water twice daily with or without food until the day prior to their end of study visit (Day 167). Participants will be instructed to not take any zinc or N-acetylcysteine supplements within 4 hours of dose.
Placebo
Dietary supplementStarting the day following their baseline B visit (Day 1), participants will be instructed to take one dose (one capsule) with water twice daily with or without food until the day prior to their end of study visit (Day 167). Participants will be instructed to not take any zinc or N-acetylcysteine supplements within 4 hours of dose.
Percentage of grey hair between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by HairMetrix
Change from baseline to Day 168 in percentage of grey hair between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by HairMetrix.
Change from baseline to Day 84 in percentage of grey hair between BioCopper1®, Restore Cu1, or Grow + Restore Cu1and placebo, as assessed by HairMetrix
Change from baseline to Day 84 in percentage of grey hair between BioCopper1®, Restore Cu1, or Grow + Restore Cu1and placebo, as assessed by HairMetrix
Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by ratio of vellus to terminal hairs
Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by ratio of vellus to terminal hairs
Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by hair density
Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by hair density
Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by hair fiber diameter
Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by hair fiber diameter
Incidence of post-emergent adverse events (AE)
Incidence of post-emergent adverse events (AE)
Clinically relevant changes in blood pressure
Clinically relevant changes in blood pressure (mm HG) after supplementation
Clinically relevant changes in heart rate
Clinically relevant changes in heart rate (bpm) after supplementation
Gastrointestinal symptoms, as assessed by the Modified Gastrointestinal Symptom Rating Scale (GSRS)
Gastrointestinal symptoms, as assessed by the Modified Gastrointestinal Symptom Rating Scale (GSRS)
Click on the lead sponsor to view all of their trials.
Mitosynergy LLC
Lead sponsor
KGK Science Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
