Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vedic Lifesciences Pvt. Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AP Brain Collagen Peptide Dose 1 | Experimental | Participants receive one 1g tablet of bovine based AP-Brain collagen peptide orally as a single dose once daily for 56 days. |
|
| AP Brain Collagen Peptide Dose 2 | Experimental | Participants receive three 1-gram tablets of bovine based AP-Brain collagen peptide orally as a single dose once daily for 56 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP-Brain Collagen Peptide | Dietary Supplement | Single dose once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjay Vaze, Dr | Contact | +91 8655670964 | sanjay.v@vediclifesciences.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omkar ENT Hospital and Research Centre | Nashik | Maharashtra | 422002 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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). | 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). | 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. | Baseline, Day 28, and Day 56 |
| Baseline and Day 56 |
| 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. | Baseline and 1 hour post-dose Day 56 |
| 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. | Baseline and 1 hour post-dose Day 56 |
| 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. | Baseline and 1 hour post-dose Day 56 |
| Change from Baseline and Different Doses on Oxidative Stress by Malondialdehyde (MDA) Levels at Day 56 | Change of MDA levels to determine systemic oxidative stress via blood sample collection. | Baseline and 1 hour post-dose Day 56 |
| Change in Baseline and Different Doses on Cognition Status by Addenbrooke's Cognitive Examination III (ACE III) at Day 56 | 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. | Baseline and Day 56 |
| Change from Baseline and Different Doses on Cyclic Glycine-Proline (cGP) Levels at Day 56 | Change of cGP levels via blood sample collection. | Baseline and 1 hour post-dose Day 56 |
| Change from Baseline and Different Doses on Insulin-Like Growth Factor-1 (IGF-1) Levels at Day 56 | Change of IGF-1 levels via blood sample collection. | Baseline and 1 hour post-dose Day 56 |
| Change from Baseline and Different Doses on Blood Pressure at Day 28 and Day 56 | Change in vitals assessed through blood pressure with units of mmHg. | Baseline, Day 28, and Day 56 |
| Safety Assessed by Liver Function Test from Baseline and Day 56 | 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. | Baseline and 1 hour post-dose Day 56 |
| Change from Baseline and Different Doses on Pulse Rate at Day 28 and Day 56 | Change in vitals assessed through pulse rate to provide beats per minute (bpm). | Baseline, Day 28, and Day 56 |
| Safety Assessed by Complete Blood Count Monitoring from Baseline and Day 56 | 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. | Baseline and 1 hour post-dose Day 56 |
| Safety Assessed by Fasting Blood Glucose from Baseline and Day 56 | Safety of test product assessed by fasting blood glucose levels obtained via blood sample. | Baseline and 1 hour post-dose Day 56 |
| Samarth Hospital | Nashik | Maharashtra | 423203 | India |
|
| New Manak Healthcare Care Hospital | Navi Mumbai | Maharashtra | 400706 | India |
|
| MGM Medical College & Hospital | Navi Mumbai | Maharashtra | 410209 | India |
|
| Punawale Multispecialty Hospital | Pimpri-Chinchwad | Maharashtra | 411033 | India |
|
| Bhaktisiddhant Hospital | Pimpri-Chinchwad | Maharashtra | 411044 | India |
|
| Pawana Hospital | Pune | Maharashtra | 410506 | India |
|
| Silver Birch Multispecialty Hospital | Pune | Maharashtra | 411041 | India |
|
| Gurukrupa Hospital | Thane | Maharashtra | 400601 | India |
|