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

May 9, 2014 updated by: Antonio Felipe Sanjuliani, Rio de Janeiro State University

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20551-030
        • Recruiting
        • Discipline of Clinical and Experimental Pathophysiology, Rio de Janeiro State University
        • Contact:
        • Sub-Investigator:
          • Thaís S Ferreira, MSc.
        • Sub-Investigator:
          • Márcia G Torres, PhD.
        • Principal Investigator:
          • Antonio F Sanjuliani, PhD.
        • Sub-Investigator:
          • Vanessa P Antunes
        • Sub-Investigator:
          • Priscila M Leal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Low calcium fatty meal
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
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
Dietary calcium from skimmed milk
Experimental: High supplementary calcium fatty meal
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
Supplementary calcium from calcium carbonate

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma triglycerides
Time Frame: Plasma triglycerides will be assessed in the fasting period and each hour during three hours after meals' intake
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
Time Frame: Plasma glucose will be assessed in the fasting period and each hour during three hours after meals' intake
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
Time Frame: Oxidative stress will be assessed in the fasting period and each hour during three hours after meals' intake
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rio de Janeiro State University

Collaborators

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Investigators

  • Principal Investigator: Antonio F Sanjuliani, PhD., Discipline of Clinical and Experimental Pathophysiology, Rio de Janeiro State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Estimate)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acute calcium

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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