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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. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

72

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Nahrungsergänzungsmittel: AP-Brain Collagen Peptide
Single dose once daily
Experimental: 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.
Nahrungsergänzungsmittel: AP-Brain Collagen Peptide
Single dose once daily

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 56
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 28
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Brain Function Assessed through Latency and Amplitude by P300 Electroencephalogram (EEG) at Baseline and Day 56
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Rousselot BVBA

Mitarbeiter

Vedic Lifesciences Pvt. Ltd.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. Juli 2026

Primärer Abschluss (Geschätzt)

1. November 2026

Studienabschluss (Geschätzt)

1. November 2026

Studienanmeldedaten

Zuerst eingereicht

29. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. April 2026

Zuerst gepostet (Tatsächlich)

7. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. September 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

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