Cognitive Ability, General
Conditions
Keywords
cognitive function, sage extract
Brief summary
Sage (Salvia officinalis) has been reported to have antioxidant, anti-inflammatory, and neuroprotective properties. Several studies indicate that sage supplementation can improve cognitive function. However, more research is needed. The purpose of this study is to examine how sage supplementation affects cognitive function and reaction times in middle-aged men and women.
Detailed description
To evaluate the effects of sage extract (sageXtra™) on cognitive function and psychomotor performance in middle-aged men and women, subjects (40-60 years) will receive 333 mg of SageXtra or placebo daily for 8 consecutive weeks.
Interventions
DIETARY_SUPPLEMENTSageXtra
333 mg/day of SageXtra sage extract powder in two #0 capsules (167 mg/capsule).
DIETARY_SUPPLEMENTPlacebo
333 mg/day of methylcellulose powder in two #0 capsules.
Sponsors
ESM Technologies, LLC
Exercise & Sport Nutrition Lab, Texas A&M University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 18.5-34.9 (inclusive) with a goal of being \< 30 on average * Subject agrees to maintain their existing dietary patterns throughout the study period. * Subject agrees to refrain from alcohol, caffeine, and strenuous exercise for 24 hours before each test day. * Subject is willing and able to comply with the study protocol. * Has given voluntary, written, informed consent to participate in the study.
Exclusion criteria
* Individuals with a personal history of a psychiatric disorder. * Individuals who are determined to have liver, renal, cardiovascular, or other metabolic disease. * Current or recent (\< 4 weeks) use of any dietary supplements (e.g., choline, lecithin, ginseng, ginkgo biloba, ashwagandha, Bacopa Monnieri, Paullina cupana, Rhodiola rosea, L-theanine, omega-3 fats, Prevagen, etc.), or currently prescribed medications (e.g., Adderall, Mydayis, Ritalin, Concerta, Mythylin, Provigil, Namenda), that may affect cognitive function (focus, concentration, memory, reaction time, energy, etc.). * Alcohol consumption (\>2 standard alcoholic drinks/day or \>10 drinks/week) or drug abuse/dependence (including regular marijuana or THC use). * Currently a smoker. * Allergy or sensitivity to study product ingredients. * Individuals who are cognitively impaired and/or who are unable to give informed consent. * Any other condition which, in the PI's opinion, may adversely affect the subject's ability to complete the study, its measurements, or pose a significant risk to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COMputerized Mental Performance ASsessment System (COMPASS) Test Battery | 4 weeks and 8 weeks | COMPASS consists of seven components including; 1) Immediate and Delayed Word Recall, 2) Delayed Word Recognition, 3) Delayed Picture Recognition, 4) Corsi Blocks Task, 5) Digit Vigilance, 6) Stroop Test and, 7) Choice Reaction Time evaluated via a computer program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical performance | 4 weeks and 8 weeks | Evaluation of reaction time via a computer program where the subject has to press a key on the keyboard when an area of the computer screen lights up. |
Countries
United States
Contacts
CONTACTRichard B. Kreider, Ph.D.
CONTACTChristopher Rasmussen, M.S.
STUDY_DIRECTORKevin J. Ruff, Ph.D.
ESM Technologies, LLC
Outcome results
None listed