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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Dietary calcium

Intervention Type OTHER

Dietary calcium from skimmed milk

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.

Group Type EXPERIMENTAL

Supplementary calcium

Intervention Type DIETARY_SUPPLEMENT

Supplementary calcium from calcium carbonate

Interventions

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Dietary calcium

Dietary calcium from skimmed milk

Intervention Type OTHER

Supplementary calcium

Supplementary calcium from calcium carbonate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No