NCT00302926

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2002

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
Last Updated

March 15, 2006

Status Verified

March 1, 2006

First QC Date

March 14, 2006

Last Update Submit

March 14, 2006

Conditions

Obesity

Keywords

Weight lossobesityenergy restriction

Outcome Measures

Primary Outcomes (5)

  • Weight loss

  • C-reactive protein

  • cardiovascular diseases markers

  • obesity

  • energy restriction

Interventions

energy restriction and maintenancePROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anita Belza

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Maintenance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

  • Anita Belza, MSci

    Department of human Nutrition, The Royal Veterinary and Agricultural University, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 15, 2006

Study Start

September 1, 2002

Study Completion

June 1, 2003

Last Updated

March 15, 2006

Record last verified: 2006-03

Locations

DK(1)