Improving cognition in healthy individuals. Not Applicable
Conditions
Interventions
Once daily for 30 days participants consume capsules containing 225 mg of a proprietary root and leaves extract of ashwagandha (NooGandha®, Specnova, Boca Raton, FL, USA) or capsules containing 225 mg
Sponsors
Specnova LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have no diagnosed cognitive deficits from a physician 2. Have no diagnosed sleep disorders from a physician 3. Have no history of cardiovascular, metabolic or pulmonary disease from a physician 4. Have no history of migraine headaches, hypertension, cardiac arrhythmias or anxiety 5. Have no ulcers or gastrointestinal reflux disease 6. Be willing to provide voluntary, written, and informed consent 7. Be willing to consume the investigational product daily for the duration of the study 8. Have no allergies to the fiber Gum Arabic
Exclusion criteria
Exclusion criteria: Participants were excluded from the study if they: 1. Were pregnant or desired pregnancy during the study 2. Had a documented history of taking prescription medications in the prior month that might affect study testing. Individuals taking medications that the investigators deemed would not affect primary study outcomes and were taken throughout the study (e.g., glucose management, lipid-lowering, anti-hypertensive, thyroid medications, etc) were permitted to participate in the study 3. Were recently instructed by their physician (within the past month) to abstain or limit caffeine and stimulant intake
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitive function measured using Computerized Mental Performance Assessment System (COMPASS) cognitive tests, including Word Recall, Word Recognition, Choice Reaction Time, Picture Recognition, Corsi Block, Digit Vigilance, and Stroop Color-Word test, at baseline, 0 and 1 hour after ingestion; and after 30 days, 0 and 1 hour after ingestion. 2. Mood assessed by Profile of Mood States (POMS) questionnaires at baseline, 0 and 1 hour after ingestion; and after 30 days, 0 and 1 hour after ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety assessed using side effect questionnaire at baseline and after 30 days of supplementation 2. Safety assessed using fasting blood draws, whole blood cell blood count with percent differential and serum metabolic panel analysis at baseline and after 30 days of supplementation 3. Cortisol levels measured using fasting salivary samples in the morning at baseline and after 30 days of supplementation | — |
Countries
United States of America
Contacts
Public ContactRichard Kreider
Outcome results
None listed