The Effect of the Treatment Program "Dr. Fedon Lindbergs Vektcoach" on Body Weight and Composition and Hormonal Profile

Obesity Clinical Trial

Official title:

The Effect of a Low Carbohydrate Low Energy Ketogenic Diet Followed by Progressively Increased Intake of Low Glycemic Foods Over 7 Months on Weight and Body Composition and Hormonal Profile

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235208
• Other study ID #: EDstudy
• Status: Completed
• Phase: N/A
• First received: November 4, 2010
• Last updated: August 14, 2012
• Start date: October 2010
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Eurodiet Scandinavia AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: The National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

The background for the trial is a number of previous studies indicating that it is especially important to restrict the intake of carbohydrates when treating overweight and metabolic diseases in general.

The purpose of the study is to obtain research data on the effects of an established treatment of overweight/obesity and its related metabolic disorders. The treatment, "Dr. Fedon Lindbergs Vektcoach", is a combination treatment where patients use low carbohydrate and low energy "Eurodiet" products in the initial phases. After the initial phases are completed, low glycemic normal foods are added to the diet until a sustainable and healthy diet is achieved. The treatment is of 7 month duration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI)>35

• BMI>27 + one risk factor for cardiovascular disease or metabolic syndrome

• >18 years

Exclusion Criteria:

• Medicinal treatment of thyroid disease

• Pregnancy or planned pregnancy

• Taking of diet pills like Xenical or Sibutramine

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Overweight

Intervention

Other:
• The "Dr. Fedon Lindbergs Vektcoach" Treatment
Diet and lifestyle treatment

Locations

Country	Name	City	State
Norway	Dr. Fedon Lindbergs Klinikk	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Eurodiet Scandinavia AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight/composition		7 months	No
Secondary	Hormonal profile		7 months	No