ACTRN12620000551998Not yet recruiting未知
A randomized placebo-controlled trial investigating the efficacy of a micronutrient formula on stress in undergraduate University of Canterbury (UC) students.
niversity of Canterbury, School of Psychology, Speech, and Hearing0 sites120 target enrollmentStarted: May 11, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 16 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1) Participants must be enrolled in an undergraduate degree at UC, 2) 16 years of age and older as long as they possess a level of understanding sufficient to complete the questionnaires and examinations required by the protocol and be considered reliable and compliant with the protocol (including the ingestion of 1 Lightning Stik/day), 3) Participants require English language competence sufficient to understand study materials and answer questionnaires, 4) Scores on the DASS-21 indicating at least mild levels of stress will be used as cut-offs for inclusion; specifically, participants will be eligible if they score 15 or above on the DASS-21 stress scale at screening (using adjusted scoring).
Exclusion Criteria
- •1) Potential participants must not have been taking psychotropic medications (e.g. antidepressants) in the prior 4 weeks nor for the trial period. 2) Any serious medical condition that might require hospitalization, 3) Any participant known to be allergic to the ingredients of the Stiks or placebo, 4) Pregnancy or breastfeeding, 5) Any medication with primarily central nervous system activity, including mood stabilizers, 6) Participation in study period 1 (semester 1) in either the active intervention or placebo group will exclude participation in study period 2 (semester 2). Participants won’t be excluded if taking any hormonal contraceptives.
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