Minerals and Botanicals for Acute Stress

NCT ID: NCT03262376

Last Updated: 2019-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2018-12-12

Brief Summary

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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

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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.

Conditions

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Stress Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
This study is double-blinded. The supplement manufacturer will independently create codes for the 4 treatment conditions. The study statistician will use the treatment codes generated to allocate participants to treatments. Researchers and participants will be blind treatment allocation.

Study Groups

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Mineral + vits + botanical A

Mineral and vitamin complex combined with Botanical A

Group Type EXPERIMENTAL

Minerals + Vitamins

Intervention Type DIETARY_SUPPLEMENT

A mineral and vitamin tablet

Botanical A

Intervention Type DIETARY_SUPPLEMENT

Botanical extract administered in capsule form

Mineral + vits + botanical B

Mineral and vitamin complex combined with Botanical B

Group Type EXPERIMENTAL

Minerals + Vitamins

Intervention Type DIETARY_SUPPLEMENT

A mineral and vitamin tablet

Botanical B

Intervention Type DIETARY_SUPPLEMENT

Botanical extract administered in capsule form

Mineral+vits +botanical A+Botanical B

Mineral and vitamin complex combined with Botanical A and Botanical B

Group Type EXPERIMENTAL

Minerals + Vitamins

Intervention Type DIETARY_SUPPLEMENT

A mineral and vitamin tablet

Botanical A

Intervention Type DIETARY_SUPPLEMENT

Botanical extract administered in capsule form

Botanical B

Intervention Type DIETARY_SUPPLEMENT

Botanical extract administered in capsule form

Placebo

Cellulose crystalline placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Cellulose crystalline tablet

Interventions

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Minerals + Vitamins

A mineral and vitamin tablet

Intervention Type DIETARY_SUPPLEMENT

Botanical A

Botanical extract administered in capsule form

Intervention Type DIETARY_SUPPLEMENT

Botanical B

Botanical extract administered in capsule form

Intervention Type DIETARY_SUPPLEMENT

Placebo

Cellulose crystalline tablet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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Prof Louise Dye

Professor of Nutrition and Behaviour

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louise Dye, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

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Human Appetite Research Unit, University of Leeds

Leeds, West Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35938130 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33896388 (View on PubMed)

Other Identifiers

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IIT15073

Identifier Type: -

Identifier Source: org_study_id

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