None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals ready to give voluntary, written informed consent to participate in the study. 2.Male and female individuals of age between 35 to 70 years (both values included). 3.Individuals with Body mass index (BMI) between 18.5 kg/m2 to 29.9 kg/m2 (both values included). 4.Perceived Stress Scale (PSS) scores between 14 to 26 (both values included). 5.Individuals with mild cognitive impairment as indicated by ACE III score between 75 to 88 (both values included). 6.Self-reported mild difficulties in focus, attention, or memory. 7.Progressive cognitive complaints like stress, disturbed sleep etc. reported by participant. 8.Individuals willing to consume an investigational product from Bovine source. 9.Individuals willing to complete all study-related and clinical study visits as per the protocol.
Exclusion criteria
Exclusion criteria: 1.Clinically diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). 2.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. 3.Individuals with a medical history of Cardiac disease, respiratory disorders, kidney disorder, liver disorder or seizure disorders or other chronic health conditions requiring medication. 4.Individuals with uncontrolled hypertension [Systolic Blood Pressure (SBP) greater than or equal to 140 mmHg or Diastolic Blood Pressure (DBP) greater than or equal to 90 mmHg]. 5.Individuals with uncontrolled diabetes [Fasting Blood Glucose (FBG) greater than equal to 126 mg/dl]. 6.Individuals with history of hypersensitivity to any components of the investigational product. 7.Those taking prescription medication or dietary supplements that affect cognitive function within 30 days prior to screening. 8.Head injury immediately preceding cognitive deterioration. 9. Consumption of excessive amounts of caffeine (more than 4-5 cups per day) and caffeine-containing foods or beverages. 10. Current smokers. 11.Those who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the Investigator s opinion. 12.Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 13.History of drug or alcohol addiction or abuse within the past 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of AP-Brain Collagen Peptides on the change in mean reaction time (ms) in comparison to baseline and different doses on Selective attention and focus as assessed by the Stroop Color-Word Test.Timepoint: Day 0 and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of AP-Brain Collagen Peptides on change in the selective attention and focus by change in mean reaction time (ms) & stroop Latency as assessed by Stroop Color-Word Test as compared to baseline and different dosesTimepoint: Day 0 and Day 28;To assess the effect of AP-Brain Collagen Peptides on change in the sustained attention by change in mean Response Time (ms), xtestomissionerrorrate, xtestcomissionerrorcount, axtestomissionerrorrate, axtestcomissionerrorcount as assessed by Continuous Performance Test (CPT), as compared to baseline and different doses.Timepoint: Day 0, Day 28, Day 56;To assess the effect of AP-Brain Collagen Peptides on change in the Memory by change in maximal digit span (maximal forward span; bML: maximal backward span fMS:expected forward span & bMS: expected backward span) as assessed by Digit Span Test as compared to baseline and different dosesTimepoint: Day 0, Day 28, Day 56;To assess the effect of AP-Brain Collagen Peptides on change in the Change in stress as assessed by Perceived Stress Scale (PSS) as compared to baseline and different doses.Timepoint: Day 0, Day 28, Day 56 | — |
Countries
India
Contacts
Vedic Lifesciences Pvt Ltd