BioCopper1 for Gray Hair and Skin Health

EL
Overseen ByErin Lewis
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Mitosynergy LLC

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in improving gray hair, hair growth, or skin health. Participants should be generally healthy and willing to take study supplements and undergo regular check-ups and assessments.

Inclusion Criteria

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)
Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use medically approved birth control for the study duration with hormonal birth control used for minimum three months
Acceptable birth control methods include hormonal contraceptives, double-barrier method, intrauterine devices, non-heterosexual lifestyle with contraception if changing to heterosexual partner(s), partner vasectomy at least 6 months prior, and abstinence with contraception if becoming sexually active
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Exclusion Criteria

Regular use of tobacco or nicotine products in past 6 months; occasional users must washout and abstain during study
Alcohol intake averaging >2 standard drinks per day as assessed by QI
Alcohol or drug abuse within last 12 months
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What Are the Treatments Tested in This Trial?

Interventions

  • BioCopper1®
  • Grow + Restore Cu1
  • Restore Cu1

Trial Overview

The study tests three products—BioCopper1®, Restore Cu1, and Grow + Restore Cu1—against a placebo to see if they improve gray hair, hair growth, or skin quality over about six months. Participants are randomly assigned to one of the groups.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Restore Cu1Experimental Treatment1 Intervention
Group II: Grow + Restore Cu1Experimental Treatment1 Intervention
Group III: BioCopper1Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mitosynergy LLC

Lead Sponsor

Trials
1
Recruited
60+

KGK Science Inc.

Industry Sponsor

Trials
82
Recruited
6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution