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CompletedNCT03262376Updated Jan 7, 2019

Minerals and Botanicals for Acute Stress

An interventional study of Minerals + Vitamins and Botanical A in Stress and Anxiety, sponsored by University of Leeds. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-07.

Sponsored by University of Leeds · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stress
  • Anxiety

Keywords

  • Stress
  • Anxiety
  • Cortisol
  • Vitamins
  • Botanicals
  • Minerals
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Mineral + vits + botanical A

    Mineral and vitamin complex combined with Botanical A

    Dietary Supplement: Minerals + Vitamins · Dietary Supplement: Botanical A

  • Experimental
    Mineral + vits + botanical B

    Mineral and vitamin complex combined with Botanical B

    Dietary Supplement: Minerals + Vitamins · Dietary Supplement: Botanical B

  • Experimental
    Mineral+vits +botanical A+Botanical B

    Mineral and vitamin complex combined with Botanical A and Botanical B

    Dietary Supplement: Minerals + Vitamins · Dietary Supplement: Botanical A · Dietary Supplement: Botanical B

  • Placebo comparator
    Placebo

    Cellulose crystalline placebo

    Other: Placebo

Interventions

  • Dietary supplementMinerals + Vitamins

    A mineral and vitamin tablet

  • Dietary supplementBotanical A

    Botanical extract administered in capsule form

  • Dietary supplementBotanical B

    Botanical extract administered in capsule form

  • OtherPlacebo

    Cellulose crystalline tablet

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 minute period, approximately 65 minutes post treatment intake

Secondary outcomes

  1. Subjective stress (Stress & Arousal Checklist; Mackay et al., 1978)

    The effect of treatment on subjective stress responses to stress induction

    Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake

  2. 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

    Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake

  3. Subjective anxiety (Spielberger State Trait Anxiety Inventory, 1983)

    The effect of treatment on subjective anxiety responses to stress induction

    Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake

  4. 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

    Time frame: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake

  5. Blood pressure

    The effect of treatment on blood pressure responses to stress induction

    Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake

  6. Heart rate

    The effect of treatment on heart rate variability before and after stress induction

    Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake

  7. Salivary cortisol

    The effect of treatment on salivary cortisol responses to stress induction

    Time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake

  8. 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

    Time frame: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake

06

Study locations

1 site
  • Human Appetite Research Unit, University of Leeds
    Leeds, West Yorkshire LS29JT, United Kingdom
07

References and documents

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 35938130 ↗
  • Boyle 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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03262376
Lead sponsor
University of Leeds
Responsible party
Prof Louise Dye (Professor of Nutrition and Behaviour, University of Leeds) — Principal investigator
First posted
Aug 25, 2017
Start date
Dec 4, 2017
Primary completion
Dec 12, 2018
Completion
Dec 12, 2018
Last update
Jan 7, 2019

Study contacts

Louise Dye, PhD
principal investigator · University of Leeds

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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