The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps (MISIT)
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.
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).
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tom Jameson, PhD
- 電話番号：+447794865520
- メール：tom.jameson@studysetgo.com
研究連絡先のバックアップ
- 名前：Christopher Koscien, PhD
- 電話番号：+44 7847617414
- メール：chris.koscien@studysetgo.com
研究場所
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Florida
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Palm Beach Gardens、Florida、アメリカ、33418
- 募集
- StudySetGo Decentralised team
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コンタクト：
- Tom Jameson
- 電話番号：+44 7794865520
- メール：tom.jameson@studysetgo.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター：プラセボ
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The placebo is manufactured by the same manufacturer that produces the active product (Vitaquest International, New Jersey, USA).
The placebo is visually similar to the active product and will be packaged in the same plain bottles as the active intervention to maintain the blind.
The placebo dose is up to 3 capsules per day taken with water.
Packaging is managed by Vitaquest International.
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実験的：Magnesium and melatonin based multi-ingredient dietary supplement
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The active intervention is a commercially available multi-ingredient dietary supplement, supplied by Imagine Biolabs LLC (trading as SaltWrap) and sold under the brand name Mag R&R.
The dose is up to 3 capsules per day taken 30 minutes before bedtime with water.
The product is stored at room temperature.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pittsburgh Sleep Quality Index (PSQI)
時間枠：From enrollment to the end of treatment at 6 weeks
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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.
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From enrollment to the end of treatment at 6 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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36-Item Short Form Health Survey (SF-36)
時間枠：From enrollment to the end of treatment at 6 weeks
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The 36-Item Short Form Health Survey (SF-36) is a self-reported questionnaire assessing health-related quality of life across eight domains.
Scale scores range from 0 to 100, with higher scores indicating better health.
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From enrollment to the end of treatment at 6 weeks
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REM sleep assessed via Oura Ring wearable
時間枠：From enrollment to the end of treatment at 6 weeks
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From enrollment to the end of treatment at 6 weeks
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。