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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

100

Phase

  • 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

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
Intervention / Treatment
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

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

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

University of Leeds

Investigators

  • 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)

December 4, 2017

Primary Completion (Actual)

December 12, 2018

Study Completion (Actual)

December 12, 2018

Study Registration Dates

First Submitted

August 14, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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