Brain, Performance and Nutrition Research Centre, Northumbria University
Newcastle upon Tyne, NE1 8ST, United Kingdom
NCT Number: NCT03639831
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Newcastle upon Tyne, NE1 8ST, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Main Exclusion Criteria:
2 capsules/ day providing the proprietary botanical extract as unique active ingredient
2 capsules/ day providing no active component
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.
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.
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.
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.
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.
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)
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)
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.
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.
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.
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.
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.
Time frame: week 2, week 4, week 8
Variation of cortisone/ cortisol urinary concentrations ratio
Time frame: week 2, week 4, week 8
Variation of allo-tetrahydrocortisol (THFs)/ tetrahydrocortisone (THE) urinary concentrations ratio
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
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.
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.
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
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.
Time frame: week 2, week 4 & week 8
Urinary metabolites
Time frame: week 2, week 4 & week 8
Change in urine F2-isoprostane
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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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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