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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235208
First Posted: November 5, 2010
Last Update Posted: August 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eurodiet Scandinavia AS
  Purpose

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.


Condition Intervention
Overweight Obesity Metabolic Syndrome Other: The "Dr. Fedon Lindbergs Vektcoach" Treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Eurodiet Scandinavia AS:

Primary Outcome Measures:
  • Body weight/composition [ Time Frame: 7 months ]

Secondary Outcome Measures:
  • Hormonal profile [ Time Frame: 7 months ]

Enrollment: 44
Study Start Date: October 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eurodiet treatment Other: The "Dr. Fedon Lindbergs Vektcoach" Treatment
Diet and lifestyle treatment

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT01235208


Locations
Norway
Dr. Fedon Lindbergs Klinikk
Oslo, Norway
Sponsors and Collaborators
Eurodiet Scandinavia AS
Investigators
Principal Investigator: Pål T Jåbekk, M.Sc
Study Director: Arne T Høstmark, Ph.D/Dr.Med Unaffiliated/ Study supervisor
  More Information

Responsible Party: Eurodiet Scandinavia AS
ClinicalTrials.gov Identifier: NCT01235208     History of Changes
Other Study ID Numbers: EDstudy
First Submitted: November 4, 2010
First Posted: November 5, 2010
Last Update Posted: August 15, 2012
Last Verified: August 2012

Keywords provided by Eurodiet Scandinavia AS:
Overweight
Obesity
Metabolic syndrome
Diet
Carbohydrate
Low glycemic index
Eurodiet

Additional relevant MeSH terms:
Overweight
Metabolic Syndrome X
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases