Minerals and Botanicals for Acute Stress

January 4, 2019 updated by: Prof Louise Dye, University of Leeds

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS29JT
        • Human Appetite Research Unit, University of Leeds

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mineral + vits + botanical A
Mineral and vitamin complex combined with Botanical A
Dietary supplement: Minerals + Vitamins
A mineral and vitamin tablet
Dietary supplement: Botanical A
Botanical extract administered in capsule form
Experimental: Mineral + vits + botanical B
Mineral and vitamin complex combined with Botanical B
Dietary supplement: Minerals + Vitamins
A mineral and vitamin tablet
Dietary supplement: Botanical B
Botanical extract administered in capsule form
Experimental: Mineral+vits +botanical A+Botanical B
Mineral and vitamin complex combined with Botanical A and Botanical B
Dietary supplement: Minerals + Vitamins
A mineral and vitamin tablet
Dietary supplement: Botanical A
Botanical extract administered in capsule form
Dietary supplement: Botanical B
Botanical extract administered in capsule form
Placebo Comparator: Placebo
Cellulose crystalline placebo
Other: Placebo
Cellulose crystalline tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
30 minute period, approximately 65 minutes post treatment intake

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
The effect of treatment on subjective stress responses to stress induction
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
The effect of treatment on subjective mood responses to stress induction
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
The effect of treatment on subjective anxiety responses to stress induction
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
The effect of treatment on reaction time and accuracy performance on two cognitive tasks of attention
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
The effect of treatment on blood pressure responses to stress induction
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
The effect of treatment on heart rate variability before and after stress induction
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
The effect of treatment on salivary cortisol responses to stress induction
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
The effect of treatment on event related potentials during execution of attentional processing
20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leeds

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Louise Dye, PhD, University of Leeds

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT15073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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