HealthyNCT07572240
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
A study testing AP-Brain Collagen Peptide in people with Healthy and Stress, run by Rousselot BVBA at 8 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- What is being tested?
- AP-Brain Collagen Peptide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 8 sitesIndia
- Study dates
- 27 Jul 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Omkar ENT Hospital and Research Centre
Nashik, Maharashtra, 422002
Samarth Hospital
Nashik, Maharashtra, 423203
New Manak Healthcare Care Hospital
Navi Mumbai, Maharashtra, 400706
Punawale Multispecialty Hospital
Pimpri-Chinchwad, Maharashtra, 411033
Bhaktisiddhant Hospital
Pimpri-Chinchwad, Maharashtra, 411044
Pawana Hospital
Pune, Maharashtra, 410506
Silver Birch Multispecialty Hospital
Pune, Maharashtra, 411041
Gurukrupa Hospital
Thane, Maharashtra, 400601
About this study
Official title: 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
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:
Read more
- 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.
- Being tested
- AP-Brain Collagen Peptide
- Keywords
- Collagen Peptides, Memory, Attention, Focus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP-Brain Collagen PeptideDietary supplement
Single dose once daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: AP-Brain Collagen Peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline, Day 28, and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start27 Jul 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rousselot BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vedic Lifesciences Pvt. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572240
- Sponsor's protocol ID
- 260201/APCP/FAM
- Other IDs
- CTRI/2026/05/110263
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07572240
- Acronym / sponsor ID
- 260201/APCP/FAM
- Keywords
- Collagen Peptides, Memory, Attention, Focus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Rousselot BVBAIndustry (pharma, biotech, devices)
- Collaborators
- Vedic Lifesciences Pvt. Ltd.
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP Brain Collagen Peptide Dose 1 | Experimental | Dietary Supplement: AP-Brain Collagen PeptideParticipants 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 | Dietary Supplement: AP-Brain Collagen PeptideParticipants receive three 1-gram tablets of bovine based AP-Brain collagen peptide orally as a single dose once daily for 56 days. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP-Brain Collagen PeptideSingle dose once daily | Dietary supplement | AP Brain Collagen Peptide Dose 1, AP Brain Collagen Peptide Dose 2 |
Primary outcome
Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 56
Time frame: Baseline and 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.
4 secondary outcomes
Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 28
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
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
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
Time frame: Baseline, Day 28, and Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AP-Brain Collagen Peptide in people with Healthy and Stress, run by Rousselot BVBA at 8 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 56 (time frame: Baseline and Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.