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NCT07839494
A Clinical Trial to Investigate the Efficacy of BioCopper1®, Restore Cu1, and Grow + Restore Cu1 on Hair and Skin Improvements in Healthy Adults
Conditions: Grey Hair, Hair Growth, Skin Health
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 88
Sponsor: Mitosynergy LLC
Location: KGK Science Inc. London Ontario
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. 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
Eligibility Criteria
Inclusion Criteria:
1. Males and females aged 18 to 45 years, inclusive
2. Stable body weight defined as a \2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
25. 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
26. Alcohol intake average of \>2 standard drinks per day as assessed by the QI
27. Alcohol or drug abuse within the last 12 months
28. 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)
29. Clinically significant abnormal laboratory results at screening as assessed by the QI
30. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
31. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
32. Individuals who are unable to give informed consent
33. 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
Source: ClinicalTrials.gov (NCT07839494). StuddyBuddy aggregates publicly available trial information.