Study About High Fat Meal and Postprandial Lipemia

NCT ID: NCT01692327

Last Updated: 2014-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-07-31

Brief Summary

The hypothesis of the proposed project is that after a fat overload, the postprandial response is different in both groups, suggesting that the LPP will present the most significant damage in endothelial vasomotion in obese individuals, especially those with GI and T2DM. After the fat overload, we hypothesized that there will be a worsening of endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but also find lower concentrations of incretins in OB/DM2 group compared to other groups.

These hypotheses may be confirmed by techniques for evaluating microvascular function, the use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic and cardiovascular read by Multiplex kit.

Detailed Description

Will be recruited 60 women aged 19-40 years, with a diagnosis of obesity (BMI ≥ 30 kg/m2) treated at the obesity clinic at the State University of Rio de Janeiro (UERJ)at Brazil.

Microcirculation parameters and blood tests will be assessed at baseline and after this, the women will receive a high-fat meal containing croissant, salami, whole milk and cheddar cheese. After 30, 60, 120 and 180 minutes this meal the microcirculation will be evaluated as well as blood collection.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Obese Group

Obese group with fat overload intake.

Group Type: OTHER

High fat meal

Intervention Type: DIETARY_SUPPLEMENT

Control Group

Control Group + fat overload intake

Group Type: OTHER

High fat meal

Intervention Type: DIETARY_SUPPLEMENT

Glucose Intolerance

glucose intolerance + fat overload intake

Group Type: OTHER

High fat meal

Intervention Type: DIETARY_SUPPLEMENT

Interventions

High fat meal

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• all patients should have obesity class I (BMI between 30 and 35kg/m2);
• Submit diabetes mellitus without further treatment or be obese non-diabetic or glucose intolerant;
• Presenting the age between 19 to 40 years.
• Waist circumference> 80 cm (IDF)

Exclusion Criteria

• Renal disease, coronary or peripheral vascular, hematologic or hepatic impairment;
• Presence of dyslipidemia;
• smokers;
• Significant loss of body weight six months prior to the study.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: lead

Responsible Party

Priscila Alves Maranhao

Nutricionist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rio de Janeiro State University

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

de Souza MDGC, Maranhao PA, Panazzolo DG, Nogueira Neto JF, Bouskela E, Kraemer-Aguiar LG. Effects of a high-fat meal on inflammatory and endothelial injury biomarkers in accordance with adiposity status: a cross-sectional study. Nutr J. 2022 Oct 19;21(1):65. doi: 10.1186/s12937-022-00819-4.

Reference Type: DERIVED

PMID: 36258233 (View on PubMed)

Other Identifiers

Biovasc002

Identifier Type: REGISTRY

Identifier Source: secondary_id

Biovasc-02

Identifier Type: -

Identifier Source: org_study_id