Grey HairNCT07839494
A Clinical Trial to Investigate the Efficacy of BioCopper1®, Restore Cu1, and Grow + Restore Cu1 on Hair and Skin Improvements in Healthy Adults
A study testing BioCopper1, Restore Cu1 and Grow + Restore Cu1 in people with Grey Hair and Hair Growth, run by Mitosynergy LLC at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Grey Hair, Hair Growth, Skin Health
- What is being tested?
- BioCopper1, Restore Cu1 and Grow + Restore Cu1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2026to Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Individuals of child-bearing potential must have a negative baseline A urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- 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
- Intrauterine devices
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- Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Abstinence and agrees to use contraception if planning on becoming sexually active during the study
- Visual confirmation of ≥ 5% and ≤ 20% of grey hair at screening
- Pattern hair loss (Savin/Ludwig Scale Criteria I-2 (early-moderate hair loss) to II-2 (moderate hair loss) for females and Hamilton-Norwood Scale Criteria II to IV-A for males) at screening as assessed by the QI (onset of hair loss/thinning not to correspond with hormonal birth control or other recent onset of new medications, as assessed by the QI)
- Agrees to maintain normal hair cleaning (frequency and use of non-medicated shampoo and/or conditioner) and general hair regime for the study period (including use of heated hair tools)
- Agrees to maintain hairstyle for the study period
- Agrees to avoid colouring hair 6 weeks prior to screening/baseline and each clinic visit
- Agrees to maintain normal skin care routine for the study period and avoid use of cosmetic products (e.g, cleansing products, creams, makeup) on the day of clinic visits
- Agrees to avoid excessive sun exposure and engage in safe sun practices for the duration of the study period
- Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history and laboratory results as assessed by the QI
Who cannot join
- 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
- Current diagnosis or history of Lyme disease
- History of or current diseases (e.g., alopecia areata) or conditions (e.g., trichotillomania, telogen effluvium, polycystic ovary syndrome) contributing to hair loss or thinning
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- Use of hair treatments, medications, or therapies for the purpose of regrowing and/or thickening (e.g., scalp treatments, hair transplantation surgery), as assessed by the QI
- Individuals with hair extensions or planning on getting hair extensions during the study period, as assessed by the QI
- Individuals with known disorders of copper metabolism (e.g., Wilson disease)
- Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
- Type I or Type II diabetes
- Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- Current diagnosis with biliary disorders
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- Self-reported confirmation of a Human Immunodeficiency Virus (HIV)-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- Use of prescribed cannabinoid products as assessed by the QI
- Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Section 7.3)
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Triple-blind, Randomized, Placebo-controlled, Parallel Clinical Trial to Investigate the Efficacy of BioCopper1®, Restore Cu1, and Grow + Restore Cu1 on Hair and Skin Improvements in Healthy Adults
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
- Conditions
- Grey Hair, Hair Growth, Skin Health
- Being tested
- BioCopper1, Restore Cu1, Grow + Restore Cu1, Placebo
- Keywords
- MitoSynergy, BioCopper1, Grow + Restore Cu1, Restore Cu1, grey hair, hair growth, skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioCopper1Dietary supplement
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 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 Cu1Dietary supplement
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 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 Cu1Dietary supplement
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 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.
PlaceboDietary supplement
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 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.
| Study group | Role | What they receive |
|---|---|---|
| BioCopper1 | Experimental | 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 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. Receives: Dietary Supplement: BioCopper1 |
| Restore Cu1 | Experimental | 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 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. Receives: Dietary Supplement: Restore Cu1 |
| Grow + Restore Cu1 | Experimental | 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 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. Receives: Dietary Supplement: Grow + Restore Cu1 |
| Placebo | Placebo comparator | 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 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1 (day -3) to visit 5 (day 168)
Secondary outcomes (10)
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
Measured: Visit 1 (day -3) 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
Measured: Visit 1 (day -3) 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
Measured: Visit 1 (day -3) 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
Measured: Visit 1 (day -3) 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
Measured: Visit 1 (day -3) 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
Measured: Visit 1 (day -3) 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.
Measured: Visit 1 (day -3) 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.
Measured: Visit 1 (day -3) 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)
Measured: 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
Measured: Visit 1 (day -3) to day 84 and day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grey HairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitosynergy LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839494
- Sponsor's protocol ID
- 26MSKGC01
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No