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| Name | Class |
|---|---|
| Rio de Janeiro State Research Supporting Foundation (FAPERJ) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low calcium fatty meal | Placebo Comparator | 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. | |
| High dietary calcium fatty meal | Experimental | 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. |
|
| High supplementary calcium fatty meal | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary calcium | Other | Dietary calcium from skimmed milk |
| |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma triglycerides | Plasma triglycerides will be assessed by automated techniques | Plasma triglycerides will be assessed in the fasting period and each hour during three hours after meals' intake |
| Plasma glucose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thaís S Ferreira, MSc. | Contact | 55 21 2334-2063 | thaissferreira@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Antonio F Sanjuliani, PhD. | Discipline of Clinical and Experimental Pathophysiology, Rio de Janeiro State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Discipline of Clinical and Experimental Pathophysiology, Rio de Janeiro State University | Recruiting | Rio de Janeiro | Rio de Janeiro | 20551-030 | Brazil |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002136 | Calcium, Dietary |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
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| Supplementary calcium |
| Dietary Supplement |
Supplementary calcium from calcium carbonate |
|
Plasma glucose will be assessed by glucose oxidase method.
| Plasma glucose will be assessed in the fasting period and each hour during three hours after meals' intake |
| Oxidative stress | Oxidative stress will be assessed by evaluating serum levels of 8-isoprostane and malondialdehyde by ELISA method. | Oxidative stress will be assessed in the fasting period and each hour during three hours after meals' intake |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |