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Effect of Relora Supplement on Anxiety, Cognitive Performance & Mood Tested After Induced Stress

NCT02734251 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-05-24

No results posted yet for this study

Summary

The present randomized, double-blind, placebo-controlled crossover trial aims to evaluate the effects of Relora supplementation on responses to induced stress produced by a combination of cognitive and physiologic stressors in healthy men and women. The effects of the supplement, compared with a placebo, will be evaluated using measures to assess anxiety \[State-Trait Anxiety Inventory-Part 1 (STAI-Part 1), mood \[Bond-Lader Visual Analog Scale (VAS)\], hypothalamic-pituitary-adrenal axis activation (salivary cortisol) and cognitive function (cognitive flexibility, reaction time, processing speed, attention, sustained attention, working memory, and executive function). Testing will be completed at the beginning and end of 7-d supplementation periods with the active and placebo products to assess both the acute effects and the "acute-on-chronic" effects following one week of daily use.

Conditions

  • Mood (Psychological Function)

Interventions

DIETARY_SUPPLEMENT

Relora

750 mg/day

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • MB Clinical Research, LLC

    collaborator UNKNOWN

  • InterHealth Nutraceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Seth J Baum, MD · MB Clinical Research

  • Kevin C Maki, PhD · MB Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02734251 on ClinicalTrials.gov