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.
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/m² to 29.9 kg/m² (both values included).
Perceived Stress Scale (PSS) scores between 14 to 26 (both values included).
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).
Parallel
AP-Brain Collagen Peptide
Dietary supplementSingle dose once daily
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.
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.
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).
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).
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.
Brain Function Assessed through Latency and Amplitude by P300 Electroencephalogram (EEG) at Baseline and Day 56
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 from Baseline and Different Doses on Synaptic Plasticity by Brain Derived Neutrophic Factor (BDNF) at Day 56
Change of BDNF levels to determine acute neurotrophic response and synaptic plasticity via blood sample collection.
Change in Baseline and Different Doses in Stress by Cortisol/Dehydroepiandrosterone sulfate (DHEAS) ratio at Day 56
Change in ratio of cortisol/DHEAS levels to determine stress via blood sample collection.
Change in Baseline and Different Doses in Inflammation by Tumor Necrosis Factor Alpha (TNF-α) Levels at Day 56
Change of TNF-α levels to determine inflammation via blood sample collection.
Click on the lead sponsor to view all of their trials.
Rousselot BVBA
Lead sponsor
Vedic Lifesciences Pvt. Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
