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Trial record 5 of 81 for:    extract | maltodextrin

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

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ClinicalTrials.gov Identifier: NCT03639831
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Northumbria University
Information provided by (Responsible Party):
Activ'inside

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.


Condition or disease Intervention/treatment Phase
Mood Disorders Dietary Supplement: Proprietary, standardized botanical extract Dietary Supplement: Placebo (maltodextrin) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : November 6, 2017
Actual Primary Completion Date : November 15, 2018
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active group
Proprietary, standardized botanical extract
Dietary Supplement: Proprietary, standardized botanical extract
2 capsules/ day providing the proprietary botanical extract as unique active ingredient

Placebo Comparator: Placebo group
Placebo (maltodextrin)
Dietary Supplement: Placebo (maltodextrin)
2 capsules/ day providing no active component




Primary Outcome Measures :
  1. Mood state [ Time Frame: Week 8 ]
    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.


Secondary Outcome Measures :
  1. POMS-2 subscores [ Time Frame: week 2, week 4, week 8 ]
    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.

  2. Anxiety state State-Trait Anxiety Inventory [ Time Frame: week 2, week 4, week 8 ]
    Variation of the State-Trait Anxiety Inventory (STAI-State) score. Min score: 20; Max score: 80. Higher score corresponds to a higher level of anxiety.

  3. Anxiety state according to the Hospital Anxiety and Depression Scale [ Time Frame: week 2, week 4, week 8 ]
    Variation of the anxiety subscore of the Hospital Anxiety and Depression Scale (HADS-A). Min score: 0; Max score: 21. Higher score corresponds to a higher level of anxiety.

  4. Percentage of responders [ Time Frame: week 2, week 4, week 8 ]
    A responder is defined as a participant with a statistically significant reduction of the POMS-2 TMD T-score. A lower POMS-2 TMD indicates a better mood state.

  5. Psychological stress [ Time Frame: week 2, week 4, week 8 ]
    Variation of the Perceived Stress Scale (PSS-10) score (min score: 0; max score: 40; a higher score corresponds to a lower psychological stress feeling)

  6. Worry feeling [ Time Frame: week 2, week 4, week 8 ]
    Variation of the Penn State Worry Questionnaire score (min score: 16; max score: 80; a higher score corresponds to a higher worry feeling)

  7. Coping response to stress [ Time Frame: week 2, week 4, week 8 ]
    Variations of the COPE inventory score (min score: 60; max score: 240). A higher score indicates that the subject uses more coping strategies in response to stress.

  8. Depressive-like state [ Time Frame: week 2, week 4, week 8 ]
    Variation of the depression subscore of the HADS (HADS-D). HADS-D score is comprised between 0 and 21. A higher HADS-D score indicates a higher level of depression.

  9. Quality of life score [ Time Frame: week 2, week 4, week 8 ]
    Variation of the World Health Organisation Quality of Life questionnaire (WHOQOL-BREF) score, comprised between 16 and 80. Higher score indicates higher quality of life.

  10. Cognitive performances [ Time Frame: week 2, week 4, week 8 ]
    Variation of the performance on serial subtractions tasks: total and correct responses at serials 3s, 7s and 17s. For Serial 3s: Participants will be instructed to count backwards in threes from a given number, as quickly and accurately as possible. For Serial 7s: same task as for serial 3s but with the serial subtraction of 7. Serial 17s: same task as for serial 3s but with the serial subtraction of 17.

  11. Cognitive performances [ Time Frame: week 2, week 4, week 8 ]
    Variation of the performance on the tracking task : speed and accuracy. In this task participants are required to use the mouse to move a cursor to attempt to track an asterisk which follows a random on-screen path. The distance between the target and the cursor is then computed every 100 ms.

  12. Diurnal cortisol secretion [ Time Frame: week 2, week 4, week 8 ]
    Variation of cortisone/ cortisol urinary concentrations ratio

  13. Diurnal cortisol metabolism [ Time Frame: week 2, week 4, week 8 ]
    Variation of allo-tetrahydrocortisol (THFs)/ tetrahydrocortisone (THE) urinary concentrations ratio

  14. Biological response to an acute stressor [ Time Frame: week 2, week 4 & week 8; at 15, 30, 45, 60 & 75 min after exposure to the stressor ]
    Incremental area under the curve (iAUC) of the salivary cortisol concentration and alpha-amylase activity

  15. Psychological response to an acute stressor assessed through the STAI [ Time Frame: week 2, week 4 & week 8; 30 and 60 min after exposure to the stressor ]
    Variation of the State-Trait Anxiety Inventory (STAI-State) score. Min score: 20; Max score: 80. Higher score corresponds to a higher level of anxiety.

  16. Psychological response to an acute stressor assessed on a Visual Analogical Scale [ Time Frame: week 2, week 4 & week 8; 30 and 60 min after exposure to the stressor ]
    Variation of the perceived stress scores obtained at a Visual Analogical Scale (VAS). Score range: 0-100. Higher score indicates a higher level of anxiety.

  17. Hemodynamic response to an acute stressor [ Time Frame: week 2, week 4 & week 8; 0 to 15 min after exposure to the stressor ]
    Maximum increase and incremental area under the curve (iAUC) of the heart rate

  18. Galvanic Skin Response to the acute stressor [ Time Frame: week 2, week 4 & week 8 ]
    Averaged raw score in microSiemens (µS) during exposure to acute stressor, likely to be comprised between 0.5 µS and 5 µS. A higher GSR indicates a higher stress state.


Other Outcome Measures:
  1. Bioavaialability [ Time Frame: week 2, week 4 & week 8 ]
    Urinary metabolites

  2. Biomarqueurs of oxidative damage [ Time Frame: week 2, week 4 & week 8 ]
    Change in urine F2-isoprostane



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639831


Locations
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United Kingdom
Brain, Performance and Nutrition Research Centre, Northumbria University
Newcastle upon Tyne, United Kingdom, NE1 8ST
Sponsors and Collaborators
Activ'inside
Northumbria University
Investigators
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Principal Investigator: David KENNEDY, PhD Brain, Performance and Nutrition Research Centre - Northumbria University

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Responsible Party: Activ'inside
ClinicalTrials.gov Identifier: NCT03639831     History of Changes
Other Study ID Numbers: PTC198-2017
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Activ'inside:
Mood
Anxiety
Stress
Dietary supplement
Botanical
Additional relevant MeSH terms:
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Mood Disorders
Mental Disorders
Hydrocortisone
Anti-Inflammatory Agents