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

Activ'inside65 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Mood Disorders

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mood state

Variation of the Profile of mood states (POMS-2) total score: TMD (Total Mood Disturbance score). The POMS-2 is a scale which includes six mood subscales: Anger, Confusion, Depression, Fatigue, Tension, and Vigor. Each subscale is scored between 0 and 100. TMD is determined by summing the Negative Mood State subscores and subtracting the Vigor subscore (unique Positive Mood State subscale). For each subscale except Vigor, a lower subscore indicates a better mood state. For the Vigor subscale, a higher subscore indicates a better mood state. A lower POMS-2 TMD indicates a better mood state.

Time frame: Week 8

Secondary Outcomes

POMS-2 subscores

Variation of the POMS-2 subscores: Anger, Confusion, Depression, Fatigue, Tension, and Vigor. Each subscale is scored between 0 and 100. For each subscale except Vigor, a lower subscore indicates a better mood state. For the Vigor subscale, a higher subscore indicates a better mood state.