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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:
Information provided by (Responsible Party):
Eurodiet Scandinavia AS
ClinicalTrials.gov Identifier:
NCT01235208
First received: November 4, 2010
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Eurodiet Scandinavia AS:

Primary Outcome Measures:
  • Body weight/composition [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hormonal profile [ Time Frame: 7 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eurodiet Scandinavia AS
ClinicalTrials.gov Identifier: NCT01235208     History of Changes
Other Study ID Numbers: EDstudy
Study First Received: November 4, 2010
Last Updated: August 14, 2012
Health Authority: Norway: The National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on May 21, 2013