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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 8
- 主要终点
- Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 56
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: AP-Brain Collagen Peptide (Dietary Supplement)
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.
干预措施: AP-Brain Collagen Peptide (Dietary Supplement)
结局指标
主要结局
Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 56
时间窗: 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.
次要结局
- Change from Baseline and Different Doses on Stress by Perceived Stress Scale (PSS) at Day 28 and Day 56(Baseline, Day 28, and Day 56)
- Change from Baseline and Different Doses on Selective Attention and Focus by Stroop Color-Word Test at Day 28(Baseline and Day 28)
- Change from Baseline and Different Doses on Sustained Attention by Continuous Performance Test (CPT) at Day 28 and Day 56(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(Baseline, Day 28, and Day 56)