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Completed

NCT Number: NCT03262376

Minerals and Botanicals for 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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Appetite Research Unit, University of Leeds

Leeds, West Yorkshire, LS29JT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minerals + Vitamins

Dietary Supplement

A mineral and vitamin tablet

Botanical A

Dietary Supplement

Botanical extract administered in capsule form

Botanical B

Dietary Supplement

Botanical extract administered in capsule form

Placebo

Other

Cellulose crystalline tablet

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Registry information

Official study title

Acute Effect of Minerals and Botanicals in Combination or Isolation on Cognitive Performance, Neural Activity, and Subjective and Cortisol Response to Acute Stress

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 25, 2017
Registry last updated
Jan 7, 2019

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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