• Randomized— You are randomly (by chance) assigned to one of the study groups to take a study product. Once you are randomly assigned to a study group, we cannot change your assigned group.

• Blinded— You will not know if you're taking an active product or a placebo product until the study ends.  You will know (from the consent form, an email, and the study insert) what potential ingredients could be included in your study product. .
  • If you have concerns regarding potential ingredients, please reach out via the form below. We can address your inquiries prior to your signing the consent form.

• Placebo-controlled— This  study group is provided a study product that appears identical to the active study product, but contains no active ingredients.

Our studies are designed to examine if and how your health changes over time. We measure health using validated questionnaires (sets of questions that have been shown to accurately measure what they're supposed to measure). We ask these questions every week so that we can assess how your responses, and corresponding health concerns, have changed throughout the study period.

We as researchers are not permitted to distribute both an active and a placebo study product to any participant. Once the study is complete, the brand that made your study product may send you coupons, vouchers, or a sample product, pending you "opt in" to hear from the brand in your final survey. This is solely at their discretion. 

Only begin taking your study product when you are ready. If you delay taking it, please fill out your surveys regardless. Simply indicate you have not taken your study product. If you have any further questions or concerns, please submit your inquiry via the form below. 

1. Data and Privacy Protection

Anytime you provide your data anywhere in the world, there’s a theoretical risk of breach of confidentiality; however, we provide multiple layers of security to protect your identity. Your study data will be entered into a password protected database and kept in a secure cloud location accessible only by members of the research team and authorized representatives.

2. Product Information

The health and wellness products used in this study vary. We have a lot of work to do to understand the safety and potential effects (if any) of health and wellness products. There’s more that we do NOT know about these products than what we DO know about them, which is why we want to study them. 

3. Possible Side Effects and Risks

 You’re advised to discuss with your healthcare provider whether it is safe for you to take part in this study.

• For some individuals, health and wellness products can result in negative side effects such as dry mouth, diarrhea, reduced appetite, drowsiness, or fatigue.
• Use of some health and wellness products with alcohol or other drugs that slow brain activity, such as those used to treat stress or insomnia, may increase sedation and drowsiness, and thereby increase risk of physical injury. 
  • If you’re taking other medications, supplements, or herbal products, there is a potential for drug interactions to occur with those products and your study product.
• If you’re taking medications that advise against grapefruit consumption, we recommend that you don’t participate in our studies, since grapefruit and some health and wellness products may have similar drug interactions.  
• If a health and wellness product contains federally legal cannabinoids such as CBD, the product places a person at risk for a positive THC drug test since the products can legally contain up to 0.3% THC.   
• Some health and wellness products may cause kidney or liver dysfunction and may cause an increase in liver enzymes.  
  • If you have known kidney or liver disease, or drink more than 3 alcoholic drinks (beer, wine, spirits) per day, you may not get to be in the study.
• The effect of some health and wellness products on pregnancy and breast milk (nursing mothers) isn’t known.   
  • If you’re pregnant, are attempting to become pregnant, or breastfeeding, you can’t take part in this study. 

We’ll periodically ask you about side effects during the study; however, if you experience any side effects from taking your study product, please report them to safety@radiclescience.com.

The study investigator and research team will use health data about you to conduct this study, as described in the consent form or as required by law. This may include your name, address, phone number, date of birth, and information from your study visits.  

When possible, the health data that is sent to the Sponsor, those working for the Sponsor, or to authorized representatives will not identify you by name.  Instead, it may include your initials, age, unique study identifier, and study visit dates.  You will not be identified by name in any published reports about this study or in any other scientific publication or presentation.  

Authorized representatives of the following organizations may look at the study records at your personal identifying information (PII) to check that the information collected for the study is correct and to make sure the study is following proper laws and guidelines:

•       Representatives of the U.S. Food and Drug Administration
•       Representatives of the IRB (ethics board)
•       Representatives of Radicle Science (Sponsor of the study)

Of course! You can always share information about the study with your primary doctor or healthcare provider. We encourage you to continue seeing your doctor throughout the study for routine visits and tests.