Calcium Over Postprandial Effects of Fatty Meal on Metabolism, Blood Pressure, Oxidative Stress, Endothelial Function.

Study Overview
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Brief Summary
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The purpose of the study is to investigate calcium acute influence over the postprandial effects of a fatty meal on serum calcium, plasma glucose and triglycerides, blood pressure, oxidative stress, and endothelial function in obese women.

Detailed Description
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Studies suggest that dietary calcium intake is inversely associated with cardiovascular disease, but supplementary calcium appears to be associated with raised risk of cardiovascular events. Fatty meals lead to oxidative and inflammation which seems to interfere in postprandial dismetabolism, a predictor of cardiovascular events. To investigate calcium acute influence over the postprandial effects of a fatty meal a crossover, controlled, and randomized clinical trial will be conducted with obese adult women who will be randomized into one of the three interventions, characterized by a fatty meal with different contents of calcium: low calcium (40 mg), high dietary calcium (540 mg from non-fat milk), and high supplementary calcium (540 mg from calcium carbonate). Each participant will receive all three meals and one of them every week. Before meals' intake blood sample will be collected and endothelial function assess will be performed. Participants will eat the specific meal and endothelial function will be assessed again after 120 minutes. Blood sample collections will be repeated every 60 minutes after meal's intake to perform latter biochemical analyzes to determine: 8-isoprostane levels, to assess oxidative stress status; triglycerides; glucose; insulin; and serum calcium. Blood pressure will be continuously assessed during 25 minutes before meals' intake and during 2 hours after it.

Official Title
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Influence of Dietary and Supplementary Calcium Over the Postprandial Effects of a Fatty Meal on Metabolism Profile, Blood Pressure, Oxidative Stress, and Endothelial Function of Obese Women.

Conditions
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Obesity

Intervention / Treatment
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* Other: Dietary calcium
* Dietary Supplement: Supplementary calcium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index (BMI) greater than or equal to 30 kg/m2 and below 40 kg/m2 habitual dietary calcium intake below 500 mg per day Exclusion Criteria: smoking dietary supplements or drugs that could interfere with body weight, metabolic profile and blood pressure diabetes thyroid dysfunction hypertension angina pectoris heart kidney or liver failure intestinal malabsorption acute or chronic inflammation HIV infection autoimmune diseases cancer chronic obstructive pulmonary disease dyslipidemia with indication for drug treatment history of myocardial infarction or stroke pregnancy and lactation menopause

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Low calcium fatty meal<br>Fatty meal consisting of biscuit, butter and drink made of albumin and sugar containing 40 mg of calcium, 600 kcal, with approximately 10% of energy from protein, 53% from fat, and 37% from carbohydrates. | |
| Experimental: High dietary calcium fatty meal<br>Fatty meal consisting of biscuit, butter and drink made of skimmed milk containing 540 mg of dietary calcium, 600 kcal, with approximately 10% of energy from protein, 53% from fat, and 37% from carbohydrates. | Other: Dietary calcium<br>* Dietary calcium from skimmed milk<br>|
| Experimental: High supplementary calcium fatty meal<br>Fatty meal consisting of biscuit, butter and drink made of albumin and sugar containing 540 mg of supplementary calcium from calcium carbonate, 600 kcal, with approximately 10% of energy from protein, 53% from fat, and 37% from carbohydrates. | Dietary Supplement: Supplementary calcium<br>* Supplementary calcium from calcium carbonate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure will be assessed by digital photoplethysmography. | Blood pressure will be assessed continuously 25 min before meals' intake and 2 hours after it. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Endothelial function will be assessed by laser doppler fluxometry. | Endothelial function will be assessed after meals' intake and 2 hours after it. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute calcium, Dietary calcium, Supplementary calcium, Postprandial metabolism