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NCT07572240
A Clinical Trial to Assess the Effect of AP-Brain Collagen Peptides on the Improvement of Attention, Focus, and Memory in Stressed But Otherwise Healthy Individuals
Conditions: Healthy, Stress
Sex: All
Ages: 35 Years – 70 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 72
Sponsor: Rousselot BVBA
Location: Omkar ENT Hospital and Research Centre Nashik Maharashtra
Summary
The goal of this clinical trial is to learn about the effects of AP-Brain collagen peptide on attention, focus, and memory in adults who are stressed but otherwise healthy.
The main questions it aims to answer are:
* How does AP-Brain affect a participant's attention, focus, stress, and memory?
* Is there a difference in the effects between a higher dose and a lower dose?
* What are the side effects, if any, for participants taking AP-Brain?
Researchers will compare two different doses of AP-Brain to see how they affect brain function and stress levels.
Participants in this study will be asked to:
* Take one of two the doses of AP-Brain once a day for 56 days.
* Visit the study center for regular checkups.
* Complete tasks that measure memory, focus, and attention.
* Answer survey questions about their stress levels.
* Provide blood samples and have vital signs checked.
* Have the brain's response to tasks monitored to see how it affects attention and alertness.
Eligibility Criteria
Inclusion Criteria:
* Individuals ready to give voluntary, written informed consent to participate in the study.
* Male and female individuals of age between 35 to 70 years (both values included).
* Individuals with body mass index (BMI) between 18.5 kg/m\^2 to 29.9 kg/m\^2 (both values included).
* Perceived Stress Scale (PSS) scores between 14 to 26 (both values included).
* Individuals with mild cognitive impairment as indicated by Addenbrooke's Cognitive Examination (ACE) III scores between 75 to 88 (both values included).
* Self-reported mild difficulties in focus, attention, or memory.
* Progressive cognitive complaints like stress, disturbed sleep etc. reported by participant.
* Individuals willing to consume an investigational product from bovine source.
* Individuals willing to complete all study-related and clinical study visits as per protocol.
Exclusion Criteria:
* Clinically diagnosed with Attention Deficit Hyperactivity Disorder (ADHD).
* Clinically diagnosed with mental disorders (diagnostic and statistical manual of mental disorders: DSM-5-TR), namely but not limited to epilepsy, anxiety, depression or Alzheimer's disease.
* Individuals with a medical history of cardiac disease, respiratory disorders, kidney disorder, liver disorder, or seizure disorders or other chronic health conditions requiring medication.
* Individuals with uncontrolled hypertension (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg).
* Individuals with uncontrolled diabetes (fasting blood glucose (FBG) greater than equal to 126 mg/dl).
* Individuals with history of hypersensitivity to any components of the investigational product.
* Those taking prescription medication or dietary supplements that affect cognitive function within 30 days prior to screening.
* Head injury immediately preceding cognitive deterioration.
* Consumption of excessive amounts of caffeine (more than 4-5 cups per day) and caffeine-containing foods or beverages.
* Current smokers.
* Those who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the Investigator's opinion.
* Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
* History of drug or alcohol addiction or abuse with the past 12 months.
Source: ClinicalTrials.gov (NCT07572240). StuddyBuddy aggregates publicly available trial information.