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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка AP-Brain Collagen Peptide
  Single dose once daily

Первичные конечные точки

• Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 56 [Срок оценки: Baseline and Day 56]

Вторичные конечные точки (4)

• Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 28 [Срок оценки: Baseline and Day 28]
• Change from Baseline and Different Doses on Sustained Attention by Continuous Performance Test (CPT) at Day 28 and Day 56 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, Day 28, and Day 56]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Индия · 9 центров

• Omkar ENT Hospital and Research Centre — Nashik
• Samarth Hospital — Nashik
• New Manak Healthcare Care Hospital — Navi Mumbai
• MGM Medical College & Hospital — Navi Mumbai
• Punawale Multispecialty Hospital — Pimpri-Chinchwad
• Bhaktisiddhant Hospital — Pimpri-Chinchwad
• Pawana Hospital — Pune
• Silver Birch Multispecialty Hospital — Pune
• … и ещё 1 центр

Идентификаторы

NCT: NCT07572240 · 260201/APCP/FAM · CTRI/2026/05/110263

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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