Trial | NCT03639831  Report issue

Title

ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS
ACUTE AND CHRONIC EFFECTS OF A PROPRIETARY BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL SECRETION AND METABOLISM IN HEALTHY ADULTS: RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND CLINICAL TRIAL

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    65
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.
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.
Study Started
Nov 06
2017
Primary Completion
Nov 15
2018
Study Completion
Mar 31
2019
Last Update
Apr 10
2019

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

Active group Experimental

Proprietary, standardized botanical extract

Placebo group Placebo Comparator

Placebo (maltodextrin)

Criteria 

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

Main 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.
No Results Posted