Impact of a Novel Nutritional Product on Cognitive Function and Related Health Outcomes

Launched by AMAZENTIS SA · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new nutritional product to see if it can help improve thinking skills and reduce problems like memory lapses or “brain fog” in adults living in the United States. The study will compare people who take the new product with those who take a placebo (a look-alike without active ingredients) over 8 weeks. Participants will answer simple surveys about their thinking and overall health through text messages or email to track any changes.

Adults aged 40 and older who live in the U.S. and are willing to take the study product without knowing if it’s the real one or the placebo may be eligible. People who are pregnant, have serious health conditions, take certain medications, or don’t have reliable internet access cannot join. If you participate, you’ll take the assigned product daily and complete short online surveys about your cognitive function and health. This study aims to find out if this new nutritional product is safe and helpful for improving brain health as people age.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participants must meet all the following criteria:
• • Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
• • o 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.
• • o 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.
• • o 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
• • Lack of reliable daily access to the internet