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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
88
Starting 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.
Starting 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.
Starting 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.
Starting 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.
KGK Science Inc.
London, Ontario, Canada
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.
Time frame: Visit 1 (day -4) to visit 5 (day 168)
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
Time frame: Visit 1 (day -4) to visit 3 (day 84)
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
Time frame: Visit 1 (day -4) to day 87
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
Time frame: Visit 1 (day -4) to day 87
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
Time frame: Visit 1 (day -4) to day 87
Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by percentage of hairs in the anagen phase
Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by percentage of hairs in the anagen phase
Time frame: Visit 1 (day -4) to day 87
Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by percentage of hairs in the telogen phase
Change from baseline to Day 87 in hair growth and density between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by percentage of hairs in the telogen phase
Time frame: Visit 1 (day -4) to day 87
Change from baseline to Day 84 between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo as assessed by Corneometer and Cutometer
Change from baseline to Day 84 between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo as assessed by Corneometer and Cutometer. The devices measure skin elasticity, firmness and hydration.
Time frame: Visit 1 (day -4) to day 84
Change from baseline to Day 84 between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo as assessed by VISIA
Change from baseline to Day 84 between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo as assessed by VISIA. The device measures wrinkles, texture, and age spots.
Time frame: Visit 1 (day -4) to day 84
Difference in perceived skin and hair improvements at Day 84 and Day 168 between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo
Difference in perceived skin and hair improvements at Day 84 and Day 168 between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by the Global Aesthetic Improvement Scales (GAISs)
Time frame: Day 84 and Day 168
Change from baseline to Day 84 and Day 168 in energy/fatigue and sleep between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo
Change from baseline to Day 84 and Day 168 in energy/fatigue and sleep between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by energy and sleep Likert scales
Time frame: Visit 1 (day -4) to day 84 and day 168
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.