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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. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

72

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Doplněk stravy: AP-Brain Collagen Peptide
Single dose once daily
Experimentální: 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.
Doplněk stravy: AP-Brain Collagen Peptide
Single dose once daily

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 56
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 28
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Brain Function Assessed through Latency and Amplitude by P300 Electroencephalogram (EEG) at Baseline and Day 56
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Rousselot BVBA

Spolupracovníci

Vedic Lifesciences Pvt. Ltd.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

27. července 2026

Primární dokončení (Odhadovaný)

1. listopadu 2026

Dokončení studie (Odhadovaný)

1. listopadu 2026

Termíny zápisu do studia

První předloženo

29. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

29. dubna 2026

První zveřejněno (Aktuální)

7. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. září 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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