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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02137434
Enrollment
15
Registered
2014-05-13
Start date
2014-02-28
Completion date
2015-12-31
Last updated
2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Acute calcium, Dietary calcium, Supplementary calcium, Postprandial metabolism

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.

Interventions

Dietary calcium from skimmed milk

DIETARY_SUPPLEMENTSupplementary calcium

Supplementary calcium from calcium carbonate

Sponsors

Rio de Janeiro State Research Supporting Foundation (FAPERJ)
CollaboratorOTHER_GOV
Rio de Janeiro State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressureBlood pressure will be assessed continuously 25 min before meals' intake and 2 hours after it.Blood pressure will be assessed by digital photoplethysmography.

Secondary

MeasureTime frameDescription
Endothelial functionEndothelial function will be assessed after meals' intake and 2 hours after it.Endothelial function will be assessed by laser doppler fluxometry.

Other

MeasureTime frameDescription
Plasma triglyceridesPlasma triglycerides will be assessed in the fasting period and each hour during three hours after meals' intakePlasma triglycerides will be assessed by automated techniques
Plasma glucosePlasma glucose will be assessed in the fasting period and each hour during three hours after meals' intakePlasma glucose will be assessed by glucose oxidase method.
Oxidative stressOxidative stress will be assessed in the fasting period and each hour during three hours after meals' intakeOxidative stress will be assessed by evaluating serum levels of 8-isoprostane and malondialdehyde by ELISA method.

Countries

Brazil

Contacts

Primary ContactThaís S Ferreira, MSc.
thaissferreira@gmail.com55 21 2334-2063

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026