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OpenTrials
Completed

NCT Number: NCT01235208

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

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.

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Key information

Conditions

Overweight Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Fedon Lindbergs Klinikk

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

The "Dr. Fedon Lindbergs Vektcoach" Treatment

Other

Diet and lifestyle treatment

Primary outcomes

  1. Body weight/composition

    Time frame: 7 months

Secondary outcomes

  1. Hormonal profile

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

Eurodiet Scandinavia AS

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 5, 2010
Registry last updated
Aug 15, 2012

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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