Healthy Adults
Conditions
Brief summary
The purpose of this study is to determine the safety and efficacy of VR-3 Herbal Blend and its effects on acute and chronic stress responses.
Interventions
DIETARY_SUPPLEMENTVR-3 Herbal Blend
This is a liquid blend of various reputed adaptogenic herbs. The dosage will be 2ml of liquid per day.
DIETARY_SUPPLEMENTPlacebo
The placebo will be a similar tasting liquid as VR-3 Herbal blend. The dosage will be 2ml of liquid per day.
Sponsors
NEMA Research, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women between the ages of 35-45 2. No health concerns as determined by study physicians 3. Women must not be pregnant or become pregnant for the duration of the study.
Exclusion criteria
1. The subject has a history of hypersensitivity to any of the compounds used in the study 2. The subject is pregnant or a lactating female. Note: If the potential subject is a post-menarcheal female, a pregnancy test (urine or serum) must be performed within 24 hours of study drug administration and confirmed negative in order for the potential subject to be enrolled). 3. History of Psychiatric Illness or Chronic Stress or Anxiety 4. Hypertension, cardiovascular disease, or other health concerns that may confound study results 5. Allergy or sensitivity to test product or ingredients 6. Individuals who are cognitively impaired or who are not able to give informed consent 7. Clinically significant or abnormal laboratory result that can confound the study 8. Medication or nutraceutical intake that can interact with the adaptogens or the biomarkers used in the study (to be determined by study physician) 9. Previous participation in a clinical research trial within 30 days prior to randomization 10. The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana. 11. The subject is actively engaging in the use of Herbal Medicine, Traditional Chinese Medicine, Ancient Indian Medicine, Yoga, or Ayurveda
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in salivary alpha-amylase and cortisol as stress biomarkers for the acute and chronic stress response following VR-3 Herbal Blend use | 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in acute psychological stress | 10 weeks |
| Change in chronic stress | 10 weeks |
Countries
United States
Outcome results
None listed