A Study on the Effects of VR-3 Herbal Blend Intake on Acute and Chronic Stress in Healthy Adults

A Pilot Double-Blind Crossover Study on the Effects of VR-3 Herbal Blend Intake on Acute and Chronic Stress and Their Biomarkers in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Dietary supplement: VR-3 Herbal Blend; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Naples, Florida, United States, 34108
      • NEMA Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Dietary supplement: VR-3 Herbal Blend; This is a liquid blend of various reputed adaptogenic herbs. The dosage will be 2ml of liquid per day.
Placebo Comparator: 2	Dietary supplement: Placebo; The placebo will be a similar tasting liquid as VR-3 Herbal blend. The dosage will be 2ml of liquid per day.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Change in acute psychological stress	10 weeks
Change in chronic stress	10 weeks

Collaborators and Investigators

• Sponsor: NEMA Research, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: August 25, 2008
• First Submitted That Met QC Criteria: August 25, 2008
• First Posted (Estimate): August 26, 2008

Study Record Updates

• Last Update Posted (Estimate): May 12, 2009
• Last Update Submitted That Met QC Criteria: May 11, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: Adaptogen Study 001