Bioavailability of Single-dose Magnesium Salts
キーワード
概要
日付
最終確認済み: | 05/31/2020 |
最初に提出された: | 10/22/2019 |
提出された推定登録数: | 10/22/2019 |
最初の投稿: | 10/24/2019 |
最終更新が送信されました: | 06/22/2020 |
最終更新日: | 06/23/2020 |
実際の研究開始日: | 07/31/2018 |
一次完了予定日: | 07/31/2020 |
研究完了予定日: | 07/31/2021 |
状態または病気
介入/治療
Dietary Supplement: Picometer-ionic form of magnesium chloride
Dietary Supplement: Magnesium citrate or magnesium oxide
Dietary Supplement: Placebo
段階
アームグループ
腕 | 介入/治療 |
---|---|
Experimental: Picometer-ionic form of magnesium chloride | Dietary Supplement: Picometer-ionic form of magnesium chloride Single-dose (300 mg) of the picometer-ionic form of magnesium chloride |
Active Comparator: Magnesium citrate or magnesium oxide | Dietary Supplement: Magnesium citrate or magnesium oxide Single-dose (300 mg) of magnesium citrate or magnesium oxide |
Placebo Comparator: Placebo | Dietary Supplement: Placebo Placebo |
適格基準
研究の対象となる年齢 | 18 Years に 18 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: 1. Age 18- 65 years 2. Body mass index 18 to 35 kg/m2 , body weight ≥ 110 pounds or 50 kg 3. All race/ethnicities and both sexes, are eligible. 4. Normal blood pressure (BP) ≤ 120/80 mm Hg. Exclusion Criteria: 1. Participant has a diagnosis of hypertension, prehypertension, diabetes, cardiovascular or other chronic disease (e.g., cancer). 2. Participant has a diagnosis of hypermagnesemia (defined as a serum concentration of > 22.8 mg/L of Magnesium) (4). 3. Participant is already taking magnesium supplementation prior to the study or taking medications that interfere with magnesium metabolism, we are providing examples in an appendix. 4. Participant has concurrent use of magnesium supplements and/or other nutrient supplements that interfere with magnesium absorption (e.g., calcium supplements) within 2-wk prior the first treatment or during the course of this study. 5. Participant has gastrointestinal disease, hepatitis, anemia, or hepatic enzyme abnormalities. 6. Women subjects are currently pregnant or trying to become pregnant. 7. Participant has a history of hospitalization for acute illness in the previous 1 month. 8. Participants who do not speak English or are unable to read or fail to comprehend the informed consent form. 9. Participants fail to complete the full medical questionnaire reviewed with them during the initial phone call (whether it be because they refuse to answer or because they don't know/understand the questions). 10. Participants who have a body weight less than 110lbs (or 50kg). 11. Participants who have donated blood within the last month, or are currently giving blood for other clinical or research purposes. 12. Participants who smoke and/or use tobacco products. |
結果
主な結果の測定
1. Ionized magnesium (whole blood) [24 hours]
2. Total magnesium in serum and urine [24 hours]
3. Exploratory / Correlative Outcome Measures [24 hours]