Study of Health and Wellness Products' Impact on Fatigue
This study will examine how health and wellness products may affect fatigue. We'll measure changes in your fatigue level using the Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A score.
Energy Active Product
+ Energy Placebo Control
Fatigue
+ Signs and Symptoms
+ Pathological Conditions, Signs and Symptoms
Other Study
Summary
Study start date: July 22, 2025
Actual date on which the first participant was enrolled.This study is focused on assessing the effectiveness of health and wellness products in reducing fatigue and improving related health outcomes. It targets adults living in the United States who are looking for a significant improvement in their health, specifically at least a 30% enhancement in their primary health outcome. The study is important as it aims to provide insights into how these products might help people feel less tired and improve their overall health. Individuals with certain health conditions, such as heart, liver, or kidney diseases, or those with safety concerns related to certain medications, are not eligible to participate. This ensures a safe and focused investigation into the products' effects. Participants will be randomly assigned to receive either the wellness product or a placebo, and neither the participants nor the researchers will know which one each participant is taking until the end of the study. All data is self-reported and collected electronically over a period of up to seven weeks, meaning participants can participate from the comfort of their own homes without needing to visit a clinic. The study collects information at the beginning, during product use, and at the end to evaluate changes in health indicators related to fatigue. This approach helps in understanding the real-world impact of these wellness products.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 21 to 105 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Participants must meet all the following criteria: Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed Resides in the United States Has the opportunity for at least 30% improvement in their primary health outcome Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study Exclusion Criteria: * Individuals who report any of the following during screening will be excluded from participation: Report being pregnant, trying to become pregnant, or breastfeeding Unable to provide a valid US shipping address and mobile phone number Reports current enrollment in another clinical trial Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) Unable to read and understand English Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk. Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk Lack of reliable daily access to the internet
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location