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

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02137434
• Other study ID #: Acute calcium
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2014
• Last updated: May 9, 2014
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2014
• Source: Rio de Janeiro State University
• Contact: Thaís S Ferreira, MSc.
• Phone: 55 21 2334-2063
• Email: thaissferreira[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Dietary calcium
Dietary calcium from skimmed milk

Dietary Supplement:
• Supplementary calcium
Supplementary calcium from calcium carbonate

Locations

Country	Name	City	State
Brazil	Discipline of Clinical and Experimental Pathophysiology, Rio de Janeiro State University	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Rio de Janeiro State University	Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Plasma glucose	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	No
Other	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	No
Primary	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.	No
Secondary	Endothelial function	Endothelial function will be assessed by laser doppler fluxometry.	Endothelial function will be assessed after meals' intake and 2 hours after it.	No