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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

4 settembre 2026 aggiornato da: Rousselot BVBA

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:

  • 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

72

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • India
    • Maharashtra
      • Nashik, Maharashtra, India, 422002
        • Reclutamento
        • Omkar ENT Hospital and Research Centre
        • Contatto:
        • Investigatore principale:
          • Mukesh More, Dr
      • Nashik, Maharashtra, India, 423203
        • Reclutamento
        • Samarth Hospital
        • Contatto:
        • Investigatore principale:
          • Abhay Nikam, Dr
      • Navi Mumbai, Maharashtra, India, 400706
        • Reclutamento
        • New Manak Healthcare Care Hospital
        • Contatto:
        • Investigatore principale:
          • Ajay Balki, Dr
      • Navi Mumbai, Maharashtra, India, 410209
        • Ritirato
        • MGM Medical College & Hospital
      • Pimpri-Chinchwad, Maharashtra, India, 411033
        • Reclutamento
        • Punawale Multispecialty Hospital
        • Contatto:
        • Investigatore principale:
          • Rajkumar Nikalje, Dr
      • Pimpri-Chinchwad, Maharashtra, India, 411044
        • Reclutamento
        • Bhaktisiddhant Hospital
        • Contatto:
        • Investigatore principale:
          • Priya Gaikwad, Dr
      • Pune, Maharashtra, India, 410506
        • Reclutamento
        • Pawana Hospital
        • Contatto:
        • Investigatore principale:
          • Pratik Wadhokar, Dr
      • Pune, Maharashtra, India, 411041
        • Reclutamento
        • Silver Birch Multispecialty Hospital
        • Contatto:
        • Investigatore principale:
          • Amar Raykantiwar, Dr
      • Thane, Maharashtra, India, 400601
        • Reclutamento
        • Gurukrupa Hospital
        • Contatto:
        • Investigatore principale:
          • Gayatri Pandit, Dr

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: AP Brain Collagen Peptide Dose 1
Participants receive one 1g tablet of bovine based AP-Brain collagen peptide orally as a single dose once daily for 56 days.
Integratore alimentare: AP-Brain Collagen Peptide
Single dose once daily
Sperimentale: AP Brain Collagen Peptide Dose 2
Participants receive three 1-gram tablets of bovine based AP-Brain collagen peptide orally as a single dose once daily for 56 days.
Integratore alimentare: AP-Brain Collagen Peptide
Single dose once daily

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 56
Lasso di tempo: 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.
Baseline and Day 56

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 28
Lasso di tempo: Baseline and 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.
Baseline and Day 28
Change from Baseline and Different Doses on Sustained Attention by Continuous Performance Test (CPT) at Day 28 and Day 56
Lasso di tempo: Baseline, 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
Lasso di tempo: Baseline, 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
Lasso di tempo: Baseline, 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Brain Function Assessed through Latency and Amplitude by P300 Electroencephalogram (EEG) at Baseline and Day 56
Lasso di tempo: 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.
Baseline and Day 56
Change from Baseline and Different Doses on Synaptic Plasticity by Brain Derived Neutrophic Factor (BDNF) at Day 56
Lasso di tempo: Baseline and 1 hour post-dose 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
Lasso di tempo: Baseline and 1 hour post-dose 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
Lasso di tempo: Baseline and 1 hour post-dose 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
Lasso di tempo: Baseline and 1 hour post-dose 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
Lasso di tempo: Baseline and 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
Lasso di tempo: Baseline and 1 hour post-dose 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
Lasso di tempo: Baseline and 1 hour post-dose 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
Lasso di tempo: Baseline, 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
Lasso di tempo: Baseline and 1 hour post-dose 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
Lasso di tempo: Baseline, 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
Lasso di tempo: Baseline and 1 hour post-dose 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
Lasso di tempo: Baseline and 1 hour post-dose Day 56
Safety of test product assessed by fasting blood glucose levels obtained via blood sample.
Baseline and 1 hour post-dose Day 56

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Rousselot BVBA

Collaboratori

Vedic Lifesciences Pvt. Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 luglio 2026

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 novembre 2026

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

7 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 settembre 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 260201/APCP/FAM
  • CTRI/2026/05/110263 (Identificatore di registro: Clinical Trials Registry-India)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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