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Clinical Trials/NCT02137434
NCT02137434
Unknown
Not Applicable

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.

Rio de Janeiro State University1 site in 1 country15 target enrollmentFebruary 2014
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Rio de Janeiro State University
Enrollment
15
Locations
1
Primary Endpoint
Blood pressure
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
December 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
Rio de Janeiro State University
Responsible Party
Principal Investigator
Principal Investigator

Antonio Felipe Sanjuliani

Associate Professor

Rio de Janeiro State University

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

  • dietary supplements or drugs that could interfere with body weight, metabolic profile and blood pressure
  • thyroid dysfunction
  • hypertension
  • angina pectoris
  • heart kidney or liver failure
  • intestinal malabsorption
  • acute or chronic inflammation
  • HIV infection
  • autoimmune diseases
  • chronic obstructive pulmonary disease

Outcomes

Primary Outcomes

Blood pressure

Time Frame: Blood pressure will be assessed continuously 25 min before meals' intake and 2 hours after it.

Blood pressure will be assessed by digital photoplethysmography.

Secondary Outcomes

  • Endothelial function(Endothelial function will be assessed after meals' intake and 2 hours after it.)

Study Sites (1)

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