Acute Effect of Minerals and Botanicals in Combination or Isolation on Cognitive Performance, Neural Activity, and Subjective and Cortisol Response to Acute Stress
| Registry | NCT03262376 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 100 (Actual) |
| Sponsor | University of Leeds (Other) |
| Conditions | Stress, Anxiety |
| Interventions | Minerals + Vitamins, Botanical A, Botanical B, Placebo (Dietary supplement, other) |
| Dates | start 2017-12-04, primary completion 2018-12-12, completion 2018-12-12, first posted 2017-08-25, last updated 2019-01-07 |
| Locations | 1 site in United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Stress All trials for Anxiety All trials of Minerals + Vitamins All trials of Botanical A
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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Mineral + vits + botanical A | Experimental | Dietary Supplement: Minerals + Vitamins; Dietary Supplement: Botanical A | Mineral and vitamin complex combined with Botanical A |
| Mineral + vits + botanical B | Experimental | Dietary Supplement: Minerals + Vitamins; Dietary Supplement: Botanical B | Mineral and vitamin complex combined with Botanical B |
| Mineral+vits +botanical A+Botanical B | Experimental | Dietary Supplement: Minerals + Vitamins; Dietary Supplement: Botanical A; Dietary Supplement: Botanical B | Mineral and vitamin complex combined with Botanical A and Botanical B |
| Placebo | Placebo comparator | Other: Placebo | Cellulose crystalline placebo |
Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Human Appetite Research Unit, University of Leeds | Leeds, West Yorkshire | United Kingdom |