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

NCT00741962 | Completed

• 1 other identifier: Adaptogen Study 001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in acute psychological stress

  10 weeks

• Change in chronic stress

  10 weeks

Study Arms (2)

1

EXPERIMENTAL

Dietary Supplement: VR-3 Herbal Blend

2

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

VR-3 Herbal Blend DIETARY_SUPPLEMENT

This is a liquid blend of various reputed adaptogenic herbs. The dosage will be 2ml of liquid per day.

1

Placebo DIETARY_SUPPLEMENT

The placebo will be a similar tasting liquid as VR-3 Herbal blend. The dosage will be 2ml of liquid per day.

2

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between the ages of 35-45
• No health concerns as determined by study physicians
• Women must not be pregnant or become pregnant for the duration of the study.

You may not qualify if:

• The subject has a history of hypersensitivity to any of the compounds used in the study
• 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).
• History of Psychiatric Illness or Chronic Stress or Anxiety
• Hypertension, cardiovascular disease, or other health concerns that may confound study results
• Allergy or sensitivity to test product or ingredients
• Individuals who are cognitively impaired or who are not able to give informed consent
• Clinically significant or abnormal laboratory result that can confound the study
• Medication or nutraceutical intake that can interact with the adaptogens or the biomarkers used in the study (to be determined by study physician)
• Previous participation in a clinical research trial within 30 days prior to randomization
• The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.
• The subject is actively engaging in the use of Herbal Medicine, Traditional Chinese Medicine, Ancient Indian Medicine, Yoga, or Ayurveda

Sponsors & Collaborators

• NEMA Research, Inc.: lead

Study Sites (1)

NEMA Research

Naples, Florida, 34108, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: August 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 12, 2009

Record last verified: 2009-05

Locations

US (1)