Clinical trial NCT02137434: Calcium Over Postprandial Effects of Fatty Meal on Metabolism, Blood Pressure, Oxidative Stress, Endothelial Function.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Acute calcium
Dietary calcium
Supplementary calcium
Postprandial metabolism
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2014-05-13
Enrollment: 15
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure
timeFrame: Blood pressure will be assessed continuously 25 min before meals' intake and 2 hours after it.
Secondary outcomes:
measure: Endothelial function
timeFrame: Endothelial function will be assessed after meals' intake and 2 hours after it.
Other outcomes:
measure: Plasma triglycerides
timeFrame: Plasma triglycerides will be assessed in the fasting period and each hour during three hours after meals' intake
measure: Plasma glucose
timeFrame: Plasma glucose will be assessed in the fasting period and each hour during three hours after meals' intake
measure: Oxidative stress
timeFrame: Oxidative stress will be assessed in the fasting period and each hour during three hours after meals' intake
Locations:
city: Rio de Janeiro
country: Brazil
facility: Discipline of Clinical and Experimental Pathophysiology, Rio de Janeiro State University
Study officials:
affiliation: Discipline of Clinical and Experimental Pathophysiology, Rio de Janeiro State University
name: Antonio F Sanjuliani, PhD.
role: PRINCIPAL_INVESTIGATOR
References: