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

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.

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.

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).

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).

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.

Event-related potentials will be elicited using a standard P300 paradigm. P3b latency and P3b amplitude will be quantified.

P3b latency will be defined as time internal (milliseconds) from stimulus onset to the maximum positive peak within expected P300 time window.

P3b amplitude will be measured as the voltage difference (microvolts) between baseline and the peak of the P3b component.

Change of BDNF levels to determine acute neurotrophic response and synaptic plasticity via blood sample collection.

Change in ratio of cortisol/DHEAS levels to determine stress via blood sample collection.

Change of TNF-α levels to determine inflammation via blood sample collection.

Change of MDA levels to determine systemic oxidative stress via blood sample collection.

Change in cognition status will be assessed using the ACE-III. The ACE-III provides a total score out of 100, where a higher score indicates better cognitive function. The assessment covers five cognitive domains of orientation/attention, memory, fluency, language, and visuospatial function.

Change of cGP levels via blood sample collection.

Change of IGF-1 levels via blood sample collection.

Change in vitals assessed through blood pressure with units of mmHg.

Safety of test product assessed by liver function test obtained via blood sample. The liver function test will include evaluation of aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, total bilirubin, and total proteins.

Change in vitals assessed through pulse rate to provide beats per minute (bpm).

Safety of test product assessed by complete blood count obtained via blood sample. The complete blood count will include evaluation of hematocrit, hemoglobin, platelet, red blood cell count, white blood cell count, neutrophil, lymphocyte, monocyte, eosinophil, and basophil.

Safety of test product assessed by fasting blood glucose levels obtained via blood sample.