A Randomized, Open-Label, Parallel Proof-of-Concept Study to Assess the Effect of AP-Brain Collagen Peptides on the Improvement of Attention, Focus, and Memory in Stressed But Otherwise Healthy Individuals

NCT07572240 | Not Yet Recruiting

• 1 other identifier: 260201/APCP/FAM
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Healthy; Stress

Keywords

Collagen Peptides; Memory; Attention; Focus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

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

  Baseline and Day 28

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

  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

  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

  Baseline, Day 28, and Day 56

Other Outcomes (10)

• Brain Function Assessed through Latency and Amplitude by P300 Electroencephalogram (EEG) at Baseline 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

  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

  Baseline and 1 hour post-dose Day 56

Study Arms (2)

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.

Dietary Supplement: AP-Brain Collagen Peptide

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.

Dietary Supplement: AP-Brain Collagen Peptide

Interventions

AP-Brain Collagen Peptide DIETARY_SUPPLEMENT

Single dose once daily

AP Brain Collagen Peptide Dose 1; AP Brain Collagen Peptide Dose 2

Eligibility Criteria

• Age: 35 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rousselot BVBA: lead
• Vedic Lifesciences Pvt. Ltd.: collaborator

Study Sites (9)

Omkar ENT Hospital and Research Centre

Nashik, Maharashtra, 422002, India

Location

Samarth Hospital

Nashik, Maharashtra, 423203, India

Location

New Manak Healthcare Care Hospital

Navi Mumbai, Maharashtra, 400706, India

Location

MGM Medical College & Hospital

Navi Mumbai, Maharashtra, 410209, India

Location

Punawale Multispecialty Hospital

Pimpri-Chinchwad, Maharashtra, 411033, India

Location

Bhaktisiddhant Hospital

Pimpri-Chinchwad, Maharashtra, 411044, India

Location

Pawana Hospital

Pune, Maharashtra, 410506, India

Location

Silver Birch Multispecialty Hospital

Pune, Maharashtra, 411041, India

Location

Gurukrupa Hospital

Thane, Maharashtra, 400601, India

Location

Central Study Contacts

Sanjay Vaze, Dr

CONTACT

+91 8655670964; sanjay.v@vediclifesciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (9)