Clinical Evaluation of the Magnesium Absorption Kinetics in Human Plasma Upon Oral Intake of Magnesium-based Products
- Conditions
- Healthy Volunteers
- Registration Number
- NCT06225349
- Lead Sponsor
- Bionos Biotech S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Healthy volunteers between 20 and 55 years of all races/ethnicities.<br><br> - Body mass index of 18-35 kg/m2.<br><br> - Last participation in a clinical study of this type must be at least 15 days before<br> the start of this study.<br><br> - Fasting conditions during 8 hours before the experiment (with the exception of low<br> mineralization water).<br><br> - No consumption of food supplements or specific food containing high levels of<br> magnesium (see attachment) during the week before the start of the treatment.<br><br>Exclusion Criteria:<br><br> - People with gastrointestinal diseases (diabetes, gastritis, Crohn's disease, celiac<br> disease, ulcers, intolerances, etc.).<br><br> - People with cardiorespiratory diseases (chronic bronchitis, chronic obstructive<br> pulmonary disease, pulmonary emphysema, asthma and bronchiectasis, thrombi, heart<br> disease, heart disorders, arrhythmias, insufficiencies, etc.).<br><br> - Pregnant or lactating women or who plan to become pregnant during the study.<br><br> - People under medical treatment in the weeks prior to the study that could interfere<br> with the evaluations of the present study (according to the investigator's<br> criteria).<br><br> - People who are within a dietary period outside their usual habit.<br><br> - People who demonstrate manifest incapacity to understand or follow the protocol or<br> the informed consent.<br><br> - Allergy or reactivity to any of the components of the product, or to a product with<br> a category similar to the tested one.<br><br> - Surgically operated for a heart condition.<br><br> - People with forecast of changing routine or relevant way of life, during the period<br> of the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantification of the changes of the magnesium levels in plasma of volunteers at time 0 hours (before consuming the product), and 1, 2, 4, 6, and 8 hours after oral intake of the product.
- Secondary Outcome Measures
Name Time Method