None listed
Conditions
Interventions
Intervention1: PhytoSpherixTM Nu: Corn extract powder capsules, taken orally, once at night post to dinner
Control Intervention1: Placebo: Microcrystalline cellulose capsules, taken orally, once at ni
Sponsors
Mibelle Ag Biochemistry
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both Male and female of age more or equal to 30 to less or equal to 55 years, with self reported mood disturbances, mild or inconsistent sleep disturbances, and high stress levels. 2. The study intervention will be given to healthy participants with absence of chronic disease and or known health conditions. 3. Female participants are either not of childbearing potential, or females of childbearing potential agree to use a medically approved method of birth control and have a negative urine pregnancy test result. 4. Participants with a Perceived Stress Questionnaire score ranging above 30. 5. Participants willing to comply or perform study treatments including questionnaires. 6. Participants able to give written informed consent and willingness to participate in the study and comply with respective procedures.
Exclusion criteria
Exclusion criteria: 1. History of chronic or severe sleep disorders. 2. Pregnant, breastfeeding, or trying to become pregnant. 3. Use of antidepressants SSRIs or MAO inhibitors. 4. Use of CNS depressants, including benzodiazepines, barbiturates, hypnotics, beta-blockers, opioids, muscle relaxants, cannabis, or recreational drugs. 5. Current use of tobacco, including e-cigarettes or vaping or smokeless tobacco. 6. History of Serotonin Syndrome. 7. History of cardiovascular disease. 8. History of autoimmune diseases (e.g., Hashimotos, Graves, SLE). 9. Clinically significant renal or liver dysfunction or disease. 10. Known Type 1 or Type 2 Diabetes Mellitus. 11. History of substance abuse, alcoholism in the past 5 years, or significant psychiatric disorder affecting study participation. 12. History or present self-harm, suicidal thoughts, or ideation. 13. History or present eating disorders (DSM-5) including anorexia, bulimia, binge eating, ARFID, pica, rumination disorder, etc. 14. History of sleep disorders in the past 5 years, including insomnia, sleep apnoea, parasomnias, narcolepsy, hypersomnolence, REM sleep behaviour disorder, restless leg syndrome, etc. 15. Any condition deemed by the Principal Investigator to preclude safe participation or confound study outcomes. 16. Any use of food supplements or functional foods including pre, pro and postbiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of change in stress by the change in Perceived stress Questionnaire (PSQ) from Baseline (Day 1) till end of the study (Day 46) in comparison with placebo.Timepoint: Day 1 to day 46 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of the investigational product on stress related biomarkers by assessing the changes in salivary cortisol, Brain-Derived Neurotrophic Factor (BDNF), pro BDNF, serotonin, GABA, adrenaline, noradrenaline, and hsCRP levels from baseline to the end of the study, in comparison with placebo from baseline (Day 1) to end of the study (Day 46). To assess the impact of the investigational product on sleep quality and emotional wellbeing through changes in Pittsburgh Sleep Quality Index (PSQI) scores and sleep and emotional parameters measured by a wearable fitness tracker, from baseline (Day 1) to end of the study (Day 46). Monitoring any adverse events.Timepoint: Day 1 to Day 46 | — |
Countries
India
Contacts
Public ContactDivya C
BioAgile Therapeutics Private Limited
Outcome results
None listed