An Investigation Into the Effect of a Daily Magnesium and Melatonin Based Multi-Ingredient Dietary Supplement on Sleep Quality in Individuals With Self-Reported Nighttime Leg Cramps.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
Participants are being invited to take part in a research study. Before deciding whether to take part, it is important for participants to understand why the research is being done and what it will involve.
Purpose: This study will investigate whether a multi-ingredient nutritional supplement containing magnesium and melatonin can improve sleep quality in adults who experience disrupted sleep due to nighttime leg cramps.
What participation involves: Participation lasts 8 weeks. Participants will be randomly assigned to take either the nutritional supplement or a placebo (inactive look-alike) every night before bed for 6 weeks. Participants will wear an Oura Ring wearable device on one finger continuously for 8 weeks throughout the study and complete short questionnaires using a smartphone app. The Oura Ring and study supplement will be sent to the participant's home address. Participants will never need to travel to a research centre; all contact with the research team will be by video call, phone, messaging, or email.
How long: Total involvement will be 8 weeks, made up of a 2-week baseline period and a 6-week supplementation period. Each day, participants will complete a short app-based questionnaire (approximately 1 minute). At the end of weeks 2, 4, 6, and 8, participants will complete additional app-based questionnaires (approximately 10 minutes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 40-75 years
- •Self-reported poor sleep quality (PSQI >5) at screening
- •Self-reported nocturnal leg cramp averaging ≥4 episodes per fortnight at screening
- •Capacity to understand and provide electronic informed consent
- •Willing to wear an Oura Ring wearable device continuously throughout the study period
- •Access to a smartphone/tablet with iOS 15 or higher and Android 9 or higher and willing to install and use the Oura and Trialflare applications
- •Be a resident of and permanently living in Florida with no planned travel across more than one time zone for at least 1 night during the study period
排除标准
- •Current or recent (within 4 weeks of randomisation) use of melatonin, magnesium, or other supplements specifically taken for sleep or leg cramps or listed as an ingredient of the intervention supplement.
- •Current use of any prescription medication
- •Diagnosed sleep disorder (e.g. obstructive sleep apnoea, restless legs syndrome, insomnia disorder)
- •Known or suspected secondary cause of nocturnal leg cramps (e.g. peripheral vascular disease, neurological condition, renal impairment, thyroid disorder)
- •Any current or prior diagnosis of:
- •Cancer or malignancy of any kind (prior malignancy is not exclusionary if the participant is in confirmed remission and has completed all treatment)
- •Cardiovascular disease (e.g. hypertension, coronary artery disease, heart failure, arrhythmia, stroke, peripheral vascular disease)
- •Autoimmune disorder (e.g. rheumatoid arthritis, lupus, multiple sclerosis)
- •Gastrointestinal disorder (e.g. IBS, malabsorption syndromes)
- •Neurological disorder (e.g. epilepsy, Parkinson's disease, dementia)
- •Hepatic or renal impairment
- •Diabetes mellitus (type 1 or type 2)
- •Severe psychiatric disorder (e.g. schizophrenia, bipolar disorder)
- •Myasthenia Gravis
- •Known hypersensitivity or allergy to any ingredient in the active or placebo product
- •Rotating shift work or irregular sleep patterns
- •Current participation in another interventional clinical trial
- •Inability to comply with study procedures or remote visit schedule
- •Breastfeeding, pregnant, or planning to become pregnant during the study period
研究组 & 干预措施
Magnesium and melatonin based multi-ingredient dietary supplement
干预措施: Magnesium and melatonin based multi-ingredient dietary supplementation (Dietary Supplement)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: From enrollment to the end of treatment at 6 weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire assessing sleep quality over the past month. Scores range from 0 to 21, where higher scores indicate poorer sleep quality.
次要结局
- 36-Item Short Form Health Survey (SF-36)(From enrollment to the end of treatment at 6 weeks)
- REM sleep assessed via Oura Ring wearable(From enrollment to the end of treatment at 6 weeks)