MedTrace Logo

ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS

NCT03639831 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2019-04-10

No results posted yet for this study

Summary

Mood disorders, including depression and anxiety, are one of the main causes of the overall disease burden worldwide.

In recent years, the efficacy of certain botanicals as an alternative solution for depression has been evaluated in a number of clinical trials.

However, only few studies looked at the effects of these botanicals on mood in healthy subjects.

The aim of the proposed randomised, double-blind, placebo-controlled, parallel groups methodology is to assess the acute and chronic effects of daily supplementation with a proprietary and standardized botanical extract in comparison to placebo in healthy adults aged 18-60 years with self-reported low mood.

Conditions

  • Mood Disorders

Interventions

DIETARY_SUPPLEMENT

Proprietary, standardized botanical extract

2 capsules/ day providing the proprietary botanical extract as unique active ingredient

DIETARY_SUPPLEMENT

Placebo (maltodextrin)

2 capsules/ day providing no active component

Sponsors & Collaborators

  • Northumbria University

    collaborator OTHER

  • Activ'inside

    lead INDUSTRY

Principal Investigators

  • David KENNEDY, PhD · Brain, Performance and Nutrition Research Centre - Northumbria University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2018-11-15
Completion
2019-03-31

Countries

  • United Kingdom

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 NCT03639831 on ClinicalTrials.gov