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Official title 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
ClinicalTrials.gov ID: NCT07572240
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- Individuals with a medical history of cardiac disease, respiratory disorders, kidney disorder, liver disorder, or seizure disorders or other chronic...
- Individuals with uncontrolled hypertension (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or...
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nashik, Maharashtra, India
- Navi Mumbai, Maharashtra, India
- Pimpri-Chinchwad, Maharashtra, India
- Pune, Maharashtra, India
- Thane, Maharashtra, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashik, Maharashtra, India; Navi Mumbai, Maharashtra, India; Pimpri-Chinchwad, Maharashtra, India; Pune, Maharashtra, India; Thane, Maharashtra, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.