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

N/AActive Not RecruitingNCT07572240

Rousselot BVBA72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Stress

Interventions

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (8)

Omkar ENT Hospital and Research Centre

Nashik, Maharashtra, India

Samarth Hospital

Nashik, Maharashtra, India

New Manak Healthcare Care Hospital

Navi Mumbai, Maharashtra, India

Punawale Multispecialty Hospital

Pimpri-Chinchwad, Maharashtra, India

Bhaktisiddhant Hospital

Pimpri-Chinchwad, Maharashtra, India

Pawana Hospital

Pune, Maharashtra, India

Silver Birch Multispecialty Hospital

Pune, Maharashtra, India

Gurukrupa Hospital

Thane, Maharashtra, India

Outcomes

Primary Outcomes

Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 56

The Stroop Color Word Test is a validated neuropsychological assessment used to measure selective attention, cognitive flexibility, processing speed, and executive control. The test requires participants to identify the ink color of printed words that may represent incongruent color names, thereby assessing the ability to inhibit automatic responses and manage cognitive interference. The change in selective attention and focus will be measured by change in mean reaction time (ms) and stroop latency by Stroop Color-Word test.

Time frame: Baseline and Day 56

Secondary Outcomes

Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 28

The Stroop Color Word Test is a validated neuropsychological assessment used to measure selective attention, cognitive flexibility, processing speed, and executive control. The test requires participants to identify the ink color of printed words that may represent incongruent color names, thereby assessing the ability to inhibit automatic responses and manage cognitive interference The change in selective attention and focus will be measured by change in mean reaction time (ms) and stroop latency by Stroop Color-Word test.

Time frame: Baseline and Day 28

Change from Baseline and Different Doses on Sustained Attention by Continuous Performance Test (CPT) at Day 28 and Day 56

The CPT measures sustained attention of participants to predefined target sequence in two phases (Phase X where participant has to respond to target "X" and phase AX where participant has to respond to target "AX" (e.g., "A" followed by "X") and withhold responses to non-target sequences. The change in sustained attention is measured through change in mean response time (ms), omission rates (xtestomissionerrorrate during phase X and axtestomissionerrorrate during phase AX), commission rates (xtestcomissionerrorrate during phase X and axtestcomissionerrorrate during phase AX).

Time frame: Baseline, Day 28, and Day 56

Change from Baseline and Different Doses on Memory by Change in Maximal Digit Span by Digit Span Test at Day 28 and Day 56

The Digit Span Test is a standardized neuropsychological measure used to assess working memory capacity and attentional control. It includes two components: Digit Span Forward, in which individuals repeat a sequence of numbers in the same order as presented, and Digit Span Backward, in which they recall the numbers in reverse order. The change in memory will be measured by change of maximum digit span the longest correctly recalled sequence length (fML: maximal forward span; bML: maximal backward span) and the mean span, defined as the list length at which 50% of sequences are correctly recalled (fMS: expected forward span correct 50% of the time across 14 trials; bMS: expected backward span correct 50% of the time across 14 trials).

Time frame: Baseline, Day 28, and Day 56

Change from Baseline and Different Doses on Stress by Perceived Stress Scale (PSS) at Day 28 and Day 56

The PSS is a 10-item questionnaire with a recall period of 1 month, designed to examine participants' self-reported levels of stress during the past month by examining their thoughts and feelings. Each question is rated on a scale of 0 (never) to 4 (very often). The PSS provides a total score out of 40, where a higher score indicates higher levels of self-perceived stress.

Time frame: Baseline, Day 28, and Day 56