StressNCT03262376
Minerals and Botanicals for Acute Stress
A study testing Minerals + Vitamins, Botanical A and Botanical B in people with Stress and Anxiety, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The objective of this acute intervention study is to examine the potential of minerals combined with botanicals to demonstrate unique and synergistic effects on oscillatory brain activity, cognitive performance, and stress reduction (endocrine, sympathetic, and subjective parameters) under conditions of acute stress… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Minerals + Vitamins, Botanical A and Botanical B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Dec 2017to 12 Dec 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults capable of giving informed consent
- Male and Female
- ≥18 - ≤50 years of age (premenopausal if female)
- Effective contraception taken in females
- Women in luteal menstrual phase
- Body mass index (BMI) ≥18 and ≤30 kg/m2
- Normal vision or corrected to normal
- Moderately stressed (subjective report)
Who cannot join
- No known intolerance to minerals, vitamins or botanicals
- Intake of prescribed medication except contraceptives
- Intake of any regular medication/supplements
- History of significant hypertensive, hepatic, renal, pulmonary, gastro-intestinal, endocrinological, neurologic, haematological, psychiatric (inc. mood disorders), cardiac or allergic disease which is clinically relevant to the study
- Hypertension (self-report or resting blood pressure >160/95 mmHg)
- Diabetes (T1 or T2)
Show all 11Show fewer
- Smoking more than occasional cigarettes (>5/day)
- Pregnant or lactating
- Previous participation in a stress study involving the Trier Social Stress Test
- Night-working/shift work
- Recreational drug use
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Appetite Research Unit, University of Leeds
Leeds, West Yorkshire, LS29JT
About this study
Official title: Acute Effect of Minerals and Botanicals in Combination or Isolation on Cognitive Performance, Neural Activity, and Subjective and Cortisol Response to Acute Stress
The objective of this acute intervention study is to examine the potential of minerals combined with botanicals to demonstrate unique and synergistic effects on oscillatory brain activity, cognitive performance, and stress reduction (endocrine, sympathetic, and subjective parameters) under conditions of acute stress in moderately stressed individuals
Read the detailed description
Botanicals in isolation or combined, will be administered with a mineral and vitamin complex to moderately stressed, healthy adults in a parallel groups fashion in this randomised placebo controlled trial. Oscillatory brain activity (EEG) during rest and performance on cognitive tasks of attention will be examined after treatment intake under conditions of acute laboratory stress. The effects of treatments on stress responses (cardiovascular, subjective and cortisol responses) will also be assessed.
- Being tested
- Minerals + Vitamins, Botanical A, Botanical B, Placebo
- Keywords
- Stress, Anxiety, Cortisol, Vitamins, Botanicals, Minerals
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minerals + VitaminsDietary supplement
A mineral and vitamin tablet
Botanical ADietary supplement
Botanical extract administered in capsule form
Botanical BDietary supplement
Botanical extract administered in capsule form
PlaceboOther
Cellulose crystalline tablet
| Study group | Role | What they receive |
|---|---|---|
| Mineral + vits + botanical A | Experimental | Mineral and vitamin complex combined with Botanical A Receives: Dietary Supplement: Minerals + Vitamins; Dietary Supplement: Botanical A |
| Mineral + vits + botanical B | Experimental | Mineral and vitamin complex combined with Botanical B Receives: Dietary Supplement: Minerals + Vitamins; Dietary Supplement: Botanical B |
| Mineral+vits +botanical A+Botanical B | Experimental | Mineral and vitamin complex combined with Botanical A and Botanical B Receives: Dietary Supplement: Minerals + Vitamins; Dietary Supplement: Botanical A; Dietary Supplement: Botanical B |
| Placebo | Placebo comparator | Cellulose crystalline placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oscillatory brain activity during the rested state and attentional processing (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system)
The effect of treatment on oscillatory brain activity during the rested state and during attentional task processing after stress exposure
Measured: 30 minute period, approximately 65 minutes post treatment intake
Secondary outcomes (8)
Subjective stress (Stress & Arousal Checklist; Mackay et al., 1978)
The effect of treatment on subjective stress responses to stress induction
Measured: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
Subjective mood (Profile of Mood States [MCNair et al., 1971] & Bond Visual analogue scales, 1974)
The effect of treatment on subjective mood responses to stress induction
Measured: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
Subjective anxiety (Spielberger State Trait Anxiety Inventory, 1983)
The effect of treatment on subjective anxiety responses to stress induction
Measured: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
Cognitive performance (Digit attention switching & threat vs neutral dot probe task)
The effect of treatment on reaction time and accuracy performance on two cognitive tasks of attention
Measured: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake
Blood pressure
The effect of treatment on blood pressure responses to stress induction
Measured: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
Heart rate
The effect of treatment on heart rate variability before and after stress induction
Measured: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
Salivary cortisol
The effect of treatment on salivary cortisol responses to stress induction
Measured: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
Event related potentials (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system)
The effect of treatment on event related potentials during execution of attentional processing
Measured: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start4 Dec 2017
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study conforms to a double blind, quasi-randomised (randomisation will be balanced across condition based on age and sex), placebo controlled, parallel group design comprising 4 treatment conditions
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Louise Dye, University of Leeds
- Investigators
- Louise Dye, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262376
- Sponsor's protocol ID
- IIT15073
- Status last verified
- Jan 2019
- First submitted
- 14 Aug 2017
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boyle NB, Dye L, Lawton CL, Billington J. A Combination of Green Tea, Rhodiola, Magnesium, and B Vitamins Increases Electroencephalogram Theta Activity During Attentional Task Performance Under Conditions of Induced Social Stress. Front Nutr. 2022 Jul 22;9:935001. doi: 10.3389/fnut.2022.935001. eCollection 2022.
PubMed 35938130Boyle NB, Billington J, Lawton C, Quadt F, Dye L. A combination of green tea, rhodiola, magnesium and B vitamins modulates brain activity and protects against the effects of induced social stress in healthy volunteers. Nutr Neurosci. 2022 Sep;25(9):1845-1859. doi: 10.1080/1028415X.2021.1909204. Epub 2021 Apr 26.
PubMed 33896388
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Minerals and Botanicals in Combination or Isolation on Cognitive Performance, Neural Activity, and Subjective and Cortisol Response to Acute Stress
- ClinicalTrials.gov ID
- NCT03262376
- Acronym / sponsor ID
- IIT15073
- Keywords
- Stress, Anxiety, Cortisol, Vitamins, Botanicals, Minerals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 25 Aug 2017 (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.
The objective of this acute intervention study is to examine the potential of minerals combined with botanicals to demonstrate unique and synergistic effects on oscillatory brain activity, cognitive performance, and stress reduction (endocrine, sympathetic, and subjective parameters) under conditions of acute stress in moderately stressed individuals
Detailed description
Botanicals in isolation or combined, will be administered with a mineral and vitamin complex to moderately stressed, healthy adults in a parallel groups fashion in this randomised placebo controlled trial. Oscillatory brain activity (EEG) during rest and performance on cognitive tasks of attention will be examined after treatment intake under conditions of acute laboratory stress. The effects of treatments on stress responses (cardiovascular, subjective and cortisol responses) will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- The study conforms to a double blind, quasi-randomised (randomisation will be balanced across condition based on age and sex), placebo controlled, parallel group design comprising 4 treatment conditions
| Arm | Type | Receives |
|---|---|---|
| Mineral + vits + botanical A | Experimental | Dietary Supplement: Minerals + Vitamins, Dietary Supplement: Botanical AMineral and vitamin complex combined with Botanical A |
| Mineral + vits + botanical B | Experimental | Dietary Supplement: Minerals + Vitamins, Dietary Supplement: Botanical BMineral and vitamin complex combined with Botanical B |
| Mineral+vits +botanical A+Botanical B | Experimental | Dietary Supplement: Minerals + Vitamins, Dietary Supplement: Botanical A, Dietary Supplement: Botanical BMineral and vitamin complex combined with Botanical A and Botanical B |
| Placebo | Placebo comparator | Other: PlaceboCellulose crystalline placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults capable of giving informed consent
- Male and Female
- ≥18 - ≤50 years of age (premenopausal if female)
- Effective contraception taken in females
- Women in luteal menstrual phase
Key exclusion criteria (11 listed)
- No known intolerance to minerals, vitamins or botanicals
- Intake of prescribed medication except contraceptives
- Intake of any regular medication/supplements
- History of significant hypertensive, hepatic, renal, pulmonary, gastro-intestinal, endocrinological, neurologic, haematological, psychiatric (inc. mood disorders), cardiac or allergic disease which is clinically relevant to the study
- Hypertension (self-report or resting blood pressure >160/95 mmHg)
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 |
|---|---|---|
| Minerals + VitaminsA mineral and vitamin tablet | Dietary supplement | Mineral + vits + botanical A, Mineral + vits + botanical B, Mineral+vits +botanical A+Botanical B |
| Botanical ABotanical extract administered in capsule form | Dietary supplement | Mineral + vits + botanical A, Mineral+vits +botanical A+Botanical B |
| Botanical BBotanical extract administered in capsule form | Dietary supplement | Mineral + vits + botanical B, Mineral+vits +botanical A+Botanical B |
| PlaceboCellulose crystalline tablet | Other | Placebo |
Primary outcome
Oscillatory brain activity during the rested state and attentional processing (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system)
Time frame: 30 minute period, approximately 65 minutes post treatment intake
The effect of treatment on oscillatory brain activity during the rested state and during attentional task processing after stress exposure
8 secondary outcomes
Subjective stress (Stress & Arousal Checklist; Mackay et al., 1978)
Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
Subjective mood (Profile of Mood States [MCNair et al., 1971] & Bond Visual analogue scales, 1974)
Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
Subjective anxiety (Spielberger State Trait Anxiety Inventory, 1983)
Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
Cognitive performance (Digit attention switching & threat vs neutral dot probe task)
Time frame: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake
Blood pressure
Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
Heart rate
Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
Salivary cortisol
Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
Event related potentials (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system)
Time frame: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake
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 7 Jan 2019.
- Derived from this study: PubMed 35938130Boyle NB, Dye L, Lawton CL, Billington J. A Combination of Green Tea, Rhodiola, Magnesium, and B Vitamins Increases Electroencephalogram Theta Activity During Attentional Task Performance Under Conditions of Induced Social Stress. Front Nutr. 2022 Jul 22;9:935001. doi: 10.3389/fnut.2022.935001. eCollection 2022.
- Derived from this study: PubMed 33896388Boyle NB, Billington J, Lawton C, Quadt F, Dye L. A combination of green tea, rhodiola, magnesium and B vitamins modulates brain activity and protects against the effects of induced social stress in healthy volunteers. Nutr Neurosci. 2022 Sep;25(9):1845-1859. doi: 10.1080/1028415X.2021.1909204. Epub 2021 Apr 26.
- 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.
Louise Dye, PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minerals + Vitamins, Botanical A and Botanical B in people with Stress and Anxiety, run by University of Leeds 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 8 inclusion and 11 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 7 Jan 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?
Oscillatory brain activity during the rested state and attentional processing (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system) (time frame: 30 minute period, approximately 65 minutes post treatment intake). 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 NCT03262376, which also lists 2 linked publications.
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 7 Jan 2019.