Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Dansk Droge A/S, Industrigrenen 10, 2635 Ishøj, Denmark
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00302926
First received: March 14, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

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 Intervention
Obesity
Procedure: energy restriction and maintenance

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: B195: Effect of Diet-Induced Energy Deficit and Body Fat Reduction on Inflammatory Markers in Obese Subjects

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Weight loss
  • C-reactive protein
  • cardiovascular diseases markers
  • obesity
  • energy restriction

Estimated Enrollment: 50
Study Start Date: September 2002
Estimated Study Completion Date: June 2003
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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00302926     History of Changes
Other Study ID Numbers: KF01-107/02
Study First Received: March 14, 2006
Last Updated: March 14, 2006
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014