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Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07572240). StuddyBuddy aggregates publicly available trial information.