Clinical trial NCT03639831: ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disorders
Keywords: Mood
Anxiety
Stress
Dietary supplement
Botanical
Lead sponsor: Activ'inside
Sponsor class: INDUSTRY
Collaborators: name: Northumbria University
First posted: 2018-08-21
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Mood state
timeFrame: Week 8
Secondary outcomes:
measure: POMS-2 subscores
timeFrame: week 2, week 4, week 8
measure: Anxiety state State-Trait Anxiety Inventory
timeFrame: week 2, week 4, week 8
measure: Anxiety state according to the Hospital Anxiety and Depression Scale
timeFrame: week 2, week 4, week 8
measure: Percentage of responders
timeFrame: week 2, week 4, week 8
measure: Psychological stress
timeFrame: week 2, week 4, week 8
measure: Worry feeling
timeFrame: week 2, week 4, week 8
measure: Coping response to stress
timeFrame: week 2, week 4, week 8
measure: Depressive-like state
timeFrame: week 2, week 4, week 8
measure: Quality of life score
timeFrame: week 2, week 4, week 8
measure: Cognitive performances
timeFrame: week 2, week 4, week 8
measure: Cognitive performances
timeFrame: week 2, week 4, week 8
measure: Diurnal cortisol secretion
timeFrame: week 2, week 4, week 8
measure: Diurnal cortisol metabolism
timeFrame: week 2, week 4, week 8
measure: Biological response to an acute stressor
timeFrame: week 2, week 4 & week 8; at 15, 30, 45, 60 & 75 min after exposure to the stressor
measure: Psychological response to an acute stressor assessed through the STAI
timeFrame: week 2, week 4 & week 8; 30 and 60 min after exposure to the stressor
measure: Psychological response to an acute stressor assessed on a Visual Analogical Scale
timeFrame: week 2, week 4 & week 8; 30 and 60 min after exposure to the stressor
measure: Hemodynamic response to an acute stressor
timeFrame: week 2, week 4 & week 8; 0 to 15 min after exposure to the stressor
measure: Galvanic Skin Response to the acute stressor
timeFrame: week 2, week 4 & week 8
Other outcomes:
measure: Bioavaialability
timeFrame: week 2, week 4 & week 8
measure: Biomarqueurs of oxidative damage
timeFrame: week 2, week 4 & week 8
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Brain, Performance and Nutrition Research Centre, Northumbria University
Study officials:
affiliation: Brain, Performance and Nutrition Research Centre - Northumbria University
name: David KENNEDY, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson PA, Forster J, Khan J, Pouchieu C, Dubreuil S, Gaudout D, Moras B, Pourtau L, Joffre F, Vaysse C, Bertrand K, Abrous H, Vauzour D, Brossaud J, Corcuff JB, Capuron L, Kennedy DO. Effects of Saffron Extract Supplementation on Mood, Well-Being, and Response to a Psychosocial Stressor in Healthy Adults: A Randomized, Double-Blind, Parallel Group, Clinical Trial. Front Nutr. 2021 Feb 1;7:606124. doi: 10.3389/fnut.2020.606124. eCollection 2020.