ACTRN12620000551998尚未招募未知
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 个研究点目标入组 120 人开始时间: 2020年5月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 16 Years 至 o limit(—)
- 性别
- All
入选标准
- •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).
排除标准
- •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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