NCT07029607尚未招募不适用
A Randomized Double Blind, Placebo Controlled Clinical Study Evaluating the Efficacy and Safety of Magnesium Supplementation on Relaxation in Adults
Olly, PBC2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes in PSS scores
研究概览
简要总结
The study will assess the efficacy of magnesium supplementation for improvement of body and mind relaxation (through stress levels), and sleep score compared to placebo, assessed by validated questionnaires. Participants will be asked to take the supplement every day for 12 weeks and will complete monthly check-ins and questionnaires. Participants will monitor adverse events in a journal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants (women + men)
- •Will maintain regular diet and exercise habits
- •Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.
排除标准
- •Neurological or psychiatric disorders
- •Pregnant or breastfeeding
- •Known allergies to magnesium-containing products
- •Taking a medication known to interact with magnesium, or taking loop diuretics, cyclosporine, digoxin, amphotericin.
- •No concurrent magnesium supplementation
- •Substance or alcohol abuse
- •Currently use, or have used within appropriate washout period, any prescription, over the counter medication, or supplements with primary CNS activity such as Antidepressants,mood stabilizer and anxiolytics, Sedatives and Stimulants
- •Anticholinergic or cholinergic medications
- •Anti-inflammatory and analgesic medication (except for PRN use)
- •Anti-allergy medication (except for non-sedating antihistamines)
- •Blood thinners
- •Other prescribed medications that may affect cognition, stress, or mood
- •Body mass index (BMI) greater than 40 kg/m2 ,
- •Individuals on angiotensin converting enzyme inhibitors for blood pressure control, other magnesium-retaining drugs, or potassium-sparing drugs
- •History of reaction to the category of product tested
- •Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
- •Subjects with any invasive medical procedures during the study.
- •Participants who are unreliable or unlikely to be available for the duration of the study.
- •No employees of PCR or the sponsor (e.g OLLY PBC, Unilever, or the H&W Collective)
结局指标
主要结局
Changes in PSS scores
时间窗: From start of study until end of the study at week 12
Monthly PSS scores will be analyzed to assess changes in stress levels across the actives and the placebo
次要结局
- Changes in Relaxation State Questionnaire scores(From start of study until end of the study at week 12)
研究者
研究点 (2)
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