Mood DisordersNCT03639831
ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS
A study testing Proprietary, standardized botanical extract in people with Mood Disorders, run by Activ'inside at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disorders
- What is being tested?
- Proprietary, standardized botanical extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2017to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 26Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain, Performance and Nutrition Research Centre, Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
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
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.
Read the 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.
- Conditions
- Mood Disorders
- Being tested
- Proprietary, standardized botanical extract, Placebo (maltodextrin)
- Keywords
- Mood, Anxiety, Stress, Dietary supplement, Botanical
- Medical subject headings
- Mood Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprietary, standardized botanical extractDietary supplement
2 capsules/ day providing the proprietary botanical extract as unique active ingredient
Placebo (maltodextrin)Dietary supplement
2 capsules/ day providing no active component
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Proprietary, standardized botanical extract Receives: Dietary Supplement: Proprietary, standardized botanical extract |
| Placebo group | Placebo comparator | Placebo (maltodextrin) Receives: Dietary Supplement: Placebo (maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (18)
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.
Measured: week 2, week 4, week 8
Anxiety state State-Trait Anxiety Inventory
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.
Measured: week 2, week 4, week 8
Anxiety state according to the Hospital Anxiety and Depression Scale
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.
Measured: week 2, week 4, week 8
Percentage of responders
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.
Measured: week 2, week 4, week 8
Psychological stress
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)
Measured: week 2, week 4, week 8
Worry feeling
Variation of the Penn State Worry Questionnaire score (min score: 16; max score: 80; a higher score corresponds to a higher worry feeling)
Measured: week 2, week 4, week 8
Coping response to stress
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.
Measured: week 2, week 4, week 8
Depressive-like state
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.
Measured: week 2, week 4, week 8
Quality of life score
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.
Measured: week 2, week 4, week 8
Cognitive performances
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.
Measured: week 2, week 4, week 8
Cognitive performances
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.
Measured: week 2, week 4, week 8
Diurnal cortisol secretion
Variation of cortisone/ cortisol urinary concentrations ratio
Measured: week 2, week 4, week 8
Diurnal cortisol metabolism
Variation of allo-tetrahydrocortisol (THFs)/ tetrahydrocortisone (THE) urinary concentrations ratio
Measured: week 2, week 4, week 8
Biological response to an acute stressor
Incremental area under the curve (iAUC) of the salivary cortisol concentration and alpha-amylase activity
Measured: week 2, week 4 & week 8; at 15, 30, 45, 60 & 75 min after exposure to the stressor
Psychological response to an acute stressor assessed through the STAI
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.
Measured: week 2, week 4 & week 8; 30 and 60 min after exposure to the stressor
Psychological response to an acute stressor assessed on a Visual Analogical Scale
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.
Measured: week 2, week 4 & week 8; 30 and 60 min after exposure to the stressor
Hemodynamic response to an acute stressor
Maximum increase and incremental area under the curve (iAUC) of the heart rate
Measured: week 2, week 4 & week 8; 0 to 15 min after exposure to the stressor
Galvanic Skin Response to the acute stressor
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.
Measured: week 2, week 4 & week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start6 Nov 2017
- Primary completion15 Nov 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Activ'inside
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northumbria University
- Responsible party
- Sponsor
- Investigators
- David KENNEDY, PhD, Principal investigator, Brain, Performance and Nutrition Research Centre - Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639831
- Sponsor's protocol ID
- PTC198-2017
- Status last verified
- Apr 2019
- First submitted
- 3 Jul 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33598475
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03639831
- Acronym / sponsor ID
- PTC198-2017
- Conditions
- Mood Disorders
- Keywords
- Mood, Anxiety, Stress, Dietary supplement, Botanical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Activ'insideIndustry (pharma, biotech, devices)
- Collaborators
- Northumbria University
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Dietary Supplement: Proprietary, standardized botanical extractProprietary, standardized botanical extract |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo (maltodextrin)Placebo (maltodextrin) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- With non-pathological feelings of anxiety and/ or stress in daily life:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprietary, standardized botanical extract2 capsules/ day providing the proprietary botanical extract as unique active ingredient | Dietary supplement | Active group |
| Placebo (maltodextrin)2 capsules/ day providing no active component | Dietary supplement | Placebo group |
Primary outcome
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.
18 secondary outcomes
POMS-2 subscores
Time frame: week 2, week 4, week 8
Anxiety state State-Trait Anxiety Inventory
Time frame: week 2, week 4, week 8
Anxiety state according to the Hospital Anxiety and Depression Scale
Time frame: week 2, week 4, week 8
Percentage of responders
Time frame: week 2, week 4, week 8
Psychological stress
Time frame: week 2, week 4, week 8
Worry feeling
Time frame: week 2, week 4, week 8
Coping response to stress
Time frame: week 2, week 4, week 8
Depressive-like state
Time frame: week 2, week 4, week 8
Quality of life score
Time frame: week 2, week 4, week 8
Cognitive performances
Time frame: week 2, week 4, week 8
Cognitive performances
Time frame: week 2, week 4, week 8
Diurnal cortisol secretion
Time frame: week 2, week 4, week 8
Diurnal cortisol metabolism
Time frame: week 2, week 4, week 8
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
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
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
Hemodynamic response to an acute stressor
Time frame: week 2, week 4 & week 8; 0 to 15 min after exposure to the stressor
Galvanic Skin Response to the acute stressor
Time frame: week 2, week 4 & week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Derived from this study: PubMed 33598475Jackson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David KENNEDY, PhD principal investigator
Brain, Performance and Nutrition Research Centre - Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprietary, standardized botanical extract in people with Mood Disorders, run by Activ'inside at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood state (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03639831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.