MedTrace Logo

A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Effects of Three Doses of the Dietary Supplement oréVida™ on Alertness, Attention and Concentration in Healthy Men and Women

NCT01143194 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2011-06-09

No results posted yet for this study

Summary

The purpose of this study is to investigate the effects of the dietary supplement oréVida™ (active ingredient on the basis of a culinary herb)administered twice daily in an acute study on an improvement in vigilance, attention, concentration, memory and mood in 45 healthy men and pre-menopausal women, aged 35-50 years, inclusive.

oréVida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. We do not claim that this supplement is meant to treat any ailment.

Conditions

  • Attention
  • Memory
  • Alertness

Interventions

DIETARY_SUPPLEMENT

oréVida™

1 capsule 30 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 60 mg/day)

DIETARY_SUPPLEMENT

oréVida™

1 capsule 60 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 120mg/day)

DIETARY_SUPPLEMENT

oréVida™

1 capsule 120 mg oréVida™ in the morning, one placebo capsule in the afternoon (si in total 120 mg/day)

DIETARY_SUPPLEMENT

Placebo

1 capsule of placebo twice a day

Sponsors & Collaborators

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Kathleen Kelley, MD · Provident Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01143194 on ClinicalTrials.gov