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Completed

NCT Number: NCT00302926

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

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).

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anita Belza

Frederiksberg, 1958, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

energy restriction and maintenance

Procedure

Primary outcomes

  1. Weight loss

  2. C-reactive protein

  3. cardiovascular diseases markers

  4. obesity

  5. energy restriction

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Dansk Droge A/S, Industrigrenen 10, 2635 Ishøj, Denmark

Registry information

Important dates

Study start
2002
Study completion
2003
First posted
Mar 15, 2006
Registry last updated
Mar 15, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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