Magnesium and Vascular Stiffness
キーワード
概要
説明
Observational epidemiologic studies have observed an inverse relationship between daily dietary magnesium intake and blood pressure. Except for blood pressure, magnesium may also beneficially affect other cardiovascular risk markers. Whether all these effects translate into improved vascular function is not known. Different vascular function markers at various stages on the pathway between diet and disease exist. One of these markers, vascular stiffness, is closely related to the process of atherosclerosis, an independent cardiovascular risk factor, and predictive of future cardiovascular events and mortality. A recently published intervention study showed that oral magnesium citrate supplementation of 350 mg per day for 24 weeks was well-tolerated and improved vascular stiffness by 1.0 m/s. Importantly, it was not established whether the beneficial effect on vascular stiffness was due to the supplementation of magnesium or due to citrate. This may involve effects on gut microbiota and systemic metabolic effects. The current study was designed to (1) reproduce the result of the earlier study and to (2) investigate whether there is a difference between different commonly used magnesium salts (magnesium citrate, magnesium sulphate and magnesium oxide) in terms of effects on vascular stiffness, blood pressure and gut microbiota.
日付
| 最終確認済み: | 07/31/2018 |
| 最初に提出された: | 08/05/2018 |
| 提出された推定登録数: | 08/12/2018 |
| 最初の投稿: | 08/14/2018 |
| 最終更新が送信されました: | 08/12/2018 |
| 最終更新日: | 08/14/2018 |
| 実際の研究開始日: | 03/26/2018 |
| 一次完了予定日: | 12/31/2019 |
| 研究完了予定日: | 12/31/2019 |
状態または病気
介入/治療
Dietary Supplement: Magnesium Citrate
Dietary Supplement: Magnesium Sulfate
Dietary Supplement: Magnesium Oxide
Drug: Placebo
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Magnesium Citrate 450 mg of Magnesium Citrate per day | Dietary Supplement: Magnesium Citrate 450 mg of Magnesium Citrate per day (6 capsules per day) for 24 weeks |
| Experimental: Magnesium Sulfate 450 mg of Magnesium Sulfate per day | Dietary Supplement: Magnesium Sulfate 450 mg of Magnesium Sulfate per day (6 capsules per day) for 24 weeks |
| Experimental: Magnesium Oxide 450 mg of Magnesium Oxide per day | Dietary Supplement: Magnesium Oxide 450 mg of Magnesium Oxide per day (6 capsules per day) for 24 weeks |
| Placebo Comparator: Placebo | Drug: Placebo The placebo capsules will contain starch (Amylum solani) for 24 weeks |
適格基準
| 研究の対象となる年齢 | 45 Years に 45 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: - Aged between 45-70 years - Women postmenopausal: two or more years after last menstruation - BMI between 25-35 kg/m2 (overweight and slightly obese) - Plasma glucose < 7.0 mmol/L - Serum total cholesterol < 8.0 mmol/L (further testing is recommended for excessive hyperlipidemia (serum total cholesterol ≥ 8.0 mmol/L) according to the Standard for cardiovascular risk management of the Dutch general practitioners community (NHG)) - Serum triacylglycerol < 4.5 mmol/L (Friedewald formula) - No current smoker - No diabetic patients - No familial hypercholesterolemia - No abuse of drugs - Less than 21 alcoholic consumptions per week - Stable body weight (weight gain or loss <3 kg in the past three months) - No use of proton pump inhibitors - No use of magnesium supplements - No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis - No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebro vascular accident - Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study - No difficult venipuncture as evidenced during the screening visit - Written informed consent Exclusion Criteria: - High habitual dietary magnesium intake (defined as urinary magnesium excretion of 7.0 or 5.9 mmol/24-h or more for men and women, respectively) - Plasma glucose ≥ 7.0 mmol/L - Serum total cholesterol ≥ 8.0 mmol/L - Serum triacylglycerol ≥ 4.5 mmol/L - Current smoker, or smoking cessation <12 months - Diabetic patients - Familial hypercholesterolemia - Abuse of drugs - More than 21 alcoholic consumptions per week - Unstable body weight (weight gain or loss > 3 kg in the past three months) - Use of proton pump inhibitors - Use of magnesium supplements - Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis - Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebro vascular accident - Not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study - Not or difficult to venipuncture as evidenced during the screening visit |
結果
主な結果の測定
1. Change in vascular stiffness [Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)]
二次的な結果の測定
1. Change in blood pressure [Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)]
2. Change in gut microbiota [Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)]
