Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults
This study aims to discover if a tonic called Feel Free® Classic can help healthy adults who feel stressed. Researchers will carefully observe if taking the tonic reduces both the feelings of stress they report and physical signs of stress. They will also investigate how the body processes the ingredients in the tonic, which are kava and kratom. These plants have traditionally been used to help with relaxation. The study is designed to be very fair, with some participants receiving the tonic and others a dummy treatment (placebo), without anyone knowing who gets what until the end. This helps ensure the results are reliable and trustworthy.
At a glance
What is this study about?
This research study is looking into a product called Feel Free® Classic Tonic. It’s designed for healthy adults who experience stress. The main goal is to find out if this tonic can actually help reduce stress, both how you feel it and how your body reacts to it. We also want to understand what happens to the tonic's ingredients inside the body after someone takes it. This information helps us learn more about how it works.
The Feel Free® Classic Tonic contains ingredients called kava and kratom. These are plants that some cultures have traditionally used to help with relaxation and improve mood. This study will help us understand these effects more scientifically. We do know from early information that this tonic seems to be generally well-tolerated, meaning most people don't have serious problems with it.
To make sure the results are fair and accurate, this study will compare the tonic with a 'dummy' product called a placebo. Neither the participants nor the healthcare team will know who is getting the real tonic and who is getting the placebo until the study is over. This is a common and important step in medical research to get reliable answers.
Key takeaways
- This study evaluates Feel Free® Classic Tonic for stress reduction.
- It involves healthy adults aged 21-55 who experience stress.
- Compares the tonic to a placebo (dummy treatment).
- Investigates the effects of kava and kratom ingredients.
- Participants must avoid alcohol, nicotine, kava, and kratom products.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be a healthy adult between 21 and 55 years old. You should also be experiencing some stress in your daily life, which we'll measure with a questionnaire. It's important that you don't have any serious ongoing health problems that aren't under control.
We would also check your body mass index (BMI), which is a measure of healthy weight, and it should be within a specific range. You shouldn't be using nicotine products (like vapes or patches), or kava or kratom products, and you'd need to agree to stop using them for a period before and during the study. You also need to be willing to avoid alcohol throughout the study.
There are also some reasons why you wouldn't be able to join. For example, if you are pregnant, planning to get pregnant, or breastfeeding. Also, if you know you're allergic to any of the ingredients in the tonic, or if certain drug tests come back positive, you wouldn't be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 21 and 55 years old?
- Do you feel stressed in your daily life?
- Are you generally healthy with no uncontrolled medical conditions?
- Are you able to avoid nicotine, alcohol, kava, and kratom products?
- Are you not pregnant, breastfeeding, or planning to become pregnant?
What does participation involve?
If you decide to take part in this study, you would be asked to attend several visits. During these visits, the study team would check your health and ask you to fill out questionnaires about your stress levels. You would also be asked to take the Feel Free® Classic Tonic or the placebo every day for a set period. Some participants might also be asked to have blood samples taken multiple times to see how the tonic’s components are processed in the body. You would need to stick to certain rules about what other medicines or supplements you take and maintain your usual diet and lifestyle as much as possible throughout the study. The total duration of your involvement in the study, including follow-up, would be fully explained by the study team.
Potential risks and benefits
Locations (1)
- ApexTrialsVerified postcodeGuelph, Canada· Recruiting
Common questions
What is a 'placebo'?
A placebo is a 'dummy' product that looks just like the real tonic but contains no active ingredients. It helps scientists compare the tonic's effects fairly.
What are kava and kratom?
Kava and kratom are plants that have been traditionally used in some cultures for their relaxing and mood-supporting properties.
Will I know if I'm getting the real tonic or the placebo?
No, during the study, neither you nor the study team will know whether you are receiving the real tonic or the placebo. This is to ensure the results are unbiased.
What does 'pharmacokinetics' mean?
It's a scientific term that basically means how your body handles a substance – how it absorbs it, where it goes, how it's used, and how it leaves your body.
What if I experience side effects?
The study team will monitor you closely for any side effects. If you experience anything unusual, you should report it to them immediately.
How to find out more
Ambreen Atif, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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