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

Activ'Inside

Status: Completed

Conditions: Mood Disorders

Treatments: Dietary Supplement: Placebo (maltodextrin); Dietary Supplement: Proprietary, standardized botanical extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03639831

PTC198-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

Active group

Experimental group

Description:

Proprietary, standardized botanical extract

Treatment:

Dietary Supplement: Proprietary, standardized botanical extract

Placebo group

Placebo Comparator group

Description:

Placebo (maltodextrin)

Treatment:

Dietary Supplement: Placebo (maltodextrin)