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B195: Effect of Diet-Induced Energy Deficit and Body Fat Reduction on Inflammatory Markers in Obese Subjects

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ClinicalTrials.gov Identifier: NCT00302926
Recruitment Status : Completed
First Posted : March 15, 2006
Last Update Posted : March 15, 2006
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Aim: To dissociate the effects on plasma concentrations of the inflammatory marker c-reactive protein of a negative energy balance and a reduction in body fat stores. Secondly to compare CRP with fibrinogen and interleukin-6 (IL-6).

Condition or disease Intervention/treatment
Obesity Procedure: energy restriction and maintenance

Detailed Description:

Background:

Previous epidemiological studies have associated elevated levels of acute phase proteins, mainly C-reactive protein, with cardiovascular diseases (CVD) and cardiac death. Levels of several cy-tokines and acute phase proteins as CRP, haptoglobin and fibrinogen have been found associated with elevated body fat and the risk of diseases associated to the metabolic syndrome.

Method:

Thirty-six otherwise healthy obese subjects (BMI: 34.23.2 kg/m2, age: 43.410.5 y) participated in a 20-week controlled dietary intervention divided into 4 periods. Weight reduction was induced by an 8-week low caloric diet (LCD) (3.4 MJ/d) followed by a 4-week weight stable maintenance program (M1). Subsequently, they underwent another 4-week LCD (4.2 MJ/d) followed by a final 4-week weight stable maintenance diet (M2). Blood samples and anthropometrical measures were assessed at baseline and after each of the four periods (8, 12, 16 and 20 weeks).


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: B195: Effect of Diet-Induced Energy Deficit and Body Fat Reduction on Inflammatory Markers in Obese Subjects
Study Start Date : September 2002
Estimated Study Completion Date : June 2003
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Weight loss
  2. C-reactive protein
  3. cardiovascular diseases markers
  4. obesity
  5. energy restriction

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 41 participants (20 men, 21 women) were included in the study. They were between 24-62y, healthy, non-athletic, weight stabile (< 3 kg in last 2 mo) but overweight to obese (BMI: 28-40 kg/m2).

Exclusion Criteria:

  • evidence of metabolic or systemic diseases other than obesity. Frequent use of medication, a systolic blood pressure >165 mmHg and diastolic blood pressure >95 mmHg.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302926


Locations
Denmark
Anita Belza
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Dansk Droge A/S, Industrigrenen 10, 2635 Ishøj, Denmark
Investigators
Principal Investigator: Anita Belza, MSci Department of human Nutrition, The Royal Veterinary and Agricultural University, Denmark
More Information

ClinicalTrials.gov Identifier: NCT00302926     History of Changes
Other Study ID Numbers: KF01-107/02
First Posted: March 15, 2006    Key Record Dates
Last Update Posted: March 15, 2006
Last Verified: March 2006

Keywords provided by University of Copenhagen:
Weight loss
obesity
energy restriction