Chapter 5 96 Materials and methods Study population This post-hoc analysis is part of an intervention trial, in which healthy overweight and slightly obese men and women received either a magnesium citrate supplement or a placebo for 24-wk. Details of the study characteristics have been described before 2. In brief, eligible participants were men and postmenopausal women, aged between 45 and 70 years old, and with a body mass index (BMI) between 25 to 35 kg/m2. They had no indications for treatment with cholesterol-lowering medications; no active cardiovascular disease; no active inflammatory disease; no endocrine disorders, such as Cushing’s syndrome, primary aldosteronism or adrenal incidentaloma; and no drug or alcohol abuse. Participants were ineligible for participation if they received protonpump inhibitors, anti-hypertensive medication or drugs known to affect serum lipid or plasma glucose metabolism. All study participants gave written consent before the screening visit. The study was conducted according to the guidelines laid down in the Declaration of Helsinki and was approved by the Medical Ethics Committee of Maastricht University Medical Center. The study was registered at ClinicalTrials.gov as NCT02235805. Study design The intervention trial had a randomized, double-blind, placebo-controlled, parallelgroup design. Study participants were allocated to receive either a magnesium citrate supplement or a placebo for 24-wk using a computer-generated randomization scheme stratified by sex. The total daily dose of magnesium was 350 mg (Magnesium Citrate Complex (Mg 16%). Placebo capsules contained starch (Amylum Solani). Capsules were provided in blister strips. Participants were requested to return all blisters at the next visit, including any unused capsules that were counted as a measure of compliance. Furthermore, participants were requested to maintain their usual diet (including consumption of alcohol), and their physical activity levels during the study period. For the current post-hoc analysis, we used 24-h urine samples that were collected at baseline and at the end of the trial. Measurements Participants received strict instructions regarding the collection of 24-h urine. They discarded the first morning urine samples and collected all urine for the following 24-h. A separate container was used to collect all urine during the night and the first morning
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