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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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The chronic effect of the active product on mood, anxiety, perceived stress, quality of life and cortisol secretion \& metabolism will be assessed through validated questionnaires and urine collection after 2, 4 and 8 weeks of daily supplementation.

The acute effect of the product will be assessed after a single dose and exposure to an acute psychological stressor. Before, during and after the stressor, saliva samples will be collected and subjective levels of anxiety and mood will be measured. In addition, Galvanic Skin Response (GSR) and heart rate (HR) will be measured throughout the stressor session.

Conditions

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Mood Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active group

Proprietary, standardized botanical extract

Group Type EXPERIMENTAL

Proprietary, standardized botanical extract

Intervention Type DIETARY_SUPPLEMENT

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

Placebo group

Placebo (maltodextrin)

Group Type PLACEBO_COMPARATOR

Placebo (maltodextrin)

Intervention Type DIETARY_SUPPLEMENT

2 capsules/ day providing no active component

Interventions

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Proprietary, standardized botanical extract

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

Intervention Type DIETARY_SUPPLEMENT

Placebo (maltodextrin)

2 capsules/ day providing no active component

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* With non-pathological feelings of anxiety and/ or stress in daily life:

* Subjects self-reporting low mood;
* Total score ≥ 40 at the Profile of Mood State (POMS 2);
* Score \< 16 at the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire
* Score ≤ 10 at the Patient Health Questionnaire 9-item (PHQ-9)
* Not meeting the diagnosis criteria for any mental disorder
* Body Mass Index (BMI) in the normal range: 18.5 ≥ BMI ≤ 30 kg/ m2
* For non-menopausal women: using effective contraception/pregnancy is not physiologically possible.
* Subject showing no difficulty for salivary sampling
* Subjects capable of and willing to comply with the protocol and to give their written informed consent

Exclusion Criteria

* Diagnosis of psychological pathology within the previous 3 years
* Diagnosis of cognitive pathology
* Anxiolytic or antidepressant treatment, within the previous 3 months
* Event likely to have impacted the subject's emotional and/ or psychological state within the last 8 weeks or planned during the next 8 weeks
* Menopausal transition
* High blood pressure
* Subjects diagnosed with diabetes, cardiovascular disease, recurrent infectious diseases or chronic inflammatory pathology
* Usual corticoid treatment/ steroidal anti-inflammatory treatment
* Unbalanced thyroid disease
* High physical activity practice
* Tobacco consumption
* Subjects consuming any food supplement
* Excessive alcohol or caffeine use
* Consumption of recreational drugs
* Subject currently participating in other clinical or nutrition intervention studies, or has done in the past 4 weeks.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes