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

Not Applicable

Not yet recruiting

• Conditions: Aging; Cognitive Decline; Brain Fog

• Registration Number: NCT07060898
• Lead Sponsor: Amazentis SA

Brief Summary

This is a parallel group, randomized, double-blind, placebo-controlled clinical study assessing the safety and effects of a novel nutritional product on self-reported cognitive function and health in adults that reside in the USA. Participants will take their assigned study product (active or placebo) for 8 weeks and answer validated electronic surveys assessing cognitive function delivered to them through a text message (SMS) link or through email.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Study Start: 2025-07-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive function as assessed by PROMIS™ Cognitive Function 8A	8 weeks	validated cognitive assessment scale

Secondary Outcome Measures

Name	Time	Method
Fatigue assessed by PROMIS™ Fatigue 4A	8 weeks	validated fatigue scale
Sleep-related impairment assessed by PROMIS™ Sleep-Related Impairment 4A	8 weeks	validated sleep quality scale
Cognitive abilities as assessed by PROMIS™ Cognitive Abilities 8A	8 weeks	validated cognitive assessment scale
Evaluation of application-based cognitive function (brain health) assessments via DANA Brain Vital app	8 weeks	smartphone application validated for cognition testing
adverse events	8 weeks