None listed
Conditions
Interventions
Intervention1: ActiSerine : Each 400 mg
capsule contains 170 mg ActiSerine
equivalent to NLT 100 mg
Phosphatidylserine
Duration is 12 weeks (84 days)
Control Intervention1: Microcrystalline Cellulos
Sponsors
Shankar Nutricon Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Individuals meeting all of the following criteria will be included in the study: 1. Individuals ready to give voluntary, written informed consent to participate in the study. 2. Males and females aged between 45 and 65 years (both values included). 3. Individuals with body mass index (BMI) between 18.5 and 29.9 kg/m2 (both values included). 4. Individuals with Subjective reports of memory or cognitive impairment (answering yes to at least one of the following) reported by the participant or caregiver: a) Do you feel your memory and thinking is getting worse? b) Do you feel your memory and thinking have become worse over the past 2-3 years? c) Are you concerned about your decline in memory and thinking? 5. Individuals willing to comply with all procedures as outlined in the informed consent.
Exclusion criteria
Exclusion criteria: Individuals meeting any of the following criteria will be excluded from the study: 1. Individuals clinically diagnosed with Attention Deficit or Hyperactivity Disorder (ADHD), dementia or dyslexia. 2. Clinically diagnosed with Alzheimer s disease. 3. Individuals diagnosed with sleep disorders like Obstructive Sleep Apnoea, narcolepsy or chronic insomnia etc. 4. Individuals with clinically significant psychiatric or neurological states that may account for cognitive impairment. 5. Recent history of physical, emotional, and social trauma within the last three months. 6. Individuals with short bowel syndrome or bariatric surgery that may affect intestinal absorption. 7. Individuals with Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) more than or equal to 2 times the upper normal limit. 8. Serum creatinine more than or equal to 1.5 times the upper normal limit. 9. Individuals with a history of hypersensitivity to any components of the IP. 10. Individuals with uncontrolled Diabetes mellitus and fasting blood glucose (FBG) more than or equal to 126 mg per dl. 11. Individuals with uncontrolled hypertension defined as SBP more than or equal to 140 mm Hg and or DBP more than or equal to 90 mm Hg. 12. Those regularly taking dietary supplements such as Lions Mane Mushroom, Bacopa monnieri, Brahmi, Centella asiatica (Asiatic Pennywort), Ginkgo biloba, Withania somnifera (Ashwagandha), Panax ginseng, Paullinia cupana (Guarana), Rhodiola rosea, Schisandra chinensis, Eleutherococcus senticosus (Siberian ginseng), Lepidium meyenii, Citicoline L-theanine, or any other, at the discretion of PI, that affect cognitive function within 1 month prior to screening. 13. Those who are unable to communicate on a daily basis due to impaired vision, hearing, and unable to write due to physical disability. 14. Head injury immediately preceding cognitive deterioration. 15. Individuals with a history or current use of psychotropic drugs or any other drugs that may significantly affect cognitive functioning during the 3 months prior to screening. 16. Participants in another clinical study or use of any Investigational Product within 90 days prior to the screening visit. 17. Individuals with a current or past history of significant disease such as epilepsy, anxiety, depression, or other psychiatric disorders; cardiovascular, respiratory, renal, hepatic, or gastrointestinal diseases; seizure disorders; or any other chronic health condition requiring medication. 18. Those who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigator s opinion. 19. Consumption of excessive amounts of caffeine (more than 4-5 cups per day) and caffeine-containing food or beverages. 20. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 21. History of drug or alcohol addiction or abuse within the past 12 months. 22. Current smokers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of Investigational Product (IP) in comparison to baseline and placebo on memory as assessed by numeric working memory, picture recognition, and word recognition tests using the Computerized Mental Performance Assessment System (COMPASS).Timepoint: Day 0 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of Investigational Product (IP) in comparison to baseline and placebo on memory as assessed by numeric working memory, picture recognition, and word recognition tests using COMPASS.Timepoint: Day 0, Day 14, Day 28, Day 56;To assess the effect of Investigational Product (IP) in comparison to baseline and placebo on attention as assessed by Simple Reaction Time, Choice Reaction Time, and Digit vigilance tasks using COMPASS.Timepoint: Day 0, Day 14, Day 28, Day 56, Day 84;To assess the effect of Investigational Product (IP) in comparison to baseline and placebo on executive function as assessed by the Stroop test using COMPASS.Timepoint: Day 0, Day 14, Day 28, Day 56, Day 84;To assess the effect of Investigational Product (IP) in comparison to baseline and placebo on mood as assessed by the Visual Analogue Mood Scale (VAMS) using COMPASS.Timepoint: Day 0, Day 14, Day 28, Day 56, Day 84;To assess the effect of Investigational Product (IP) in comparison to baseline and placebo on sleep quality as assessed by the Pittsburgh Sleep Quality Index(PSQI).Timepoint: Day 0 and Day 84;To assess the effect of Investigational Product (IP) in comparison to baseline and placebo on quality of life as assessed by the World Health Organization Quality of Life assessment (WHO-QoL).Timepoint: Day 0 and Day 84 | — |
Countries
India
Contacts
Public ContactDr Shubhangi Mote
Vedic Lifesciences Pvt Ltd
Outcome results
None listed