search
Back to results

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

Primary Purpose

Overweight, Obesity, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
The "Dr. Fedon Lindbergs Vektcoach" Treatment
Sponsored by
Eurodiet Scandinavia AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overweight focused on measuring Overweight, Obesity, Metabolic syndrome, Diet, Carbohydrate, Low glycemic index, Eurodiet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Fedon Lindbergs Klinikk

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eurodiet treatment

Arm Description

Outcomes

Primary Outcome Measures

Body weight/composition

Secondary Outcome Measures

Hormonal profile

Full Information

First Posted
November 4, 2010
Last Updated
August 14, 2012
Sponsor
Eurodiet Scandinavia AS
search

1. Study Identification

Unique Protocol Identification Number
NCT01235208
Brief Title
The Effect of the Treatment Program "Dr. Fedon Lindbergs Vektcoach" on Body Weight and Composition and Hormonal Profile
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurodiet Scandinavia AS

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Metabolic Syndrome
Keywords
Overweight, Obesity, Metabolic syndrome, Diet, Carbohydrate, Low glycemic index, Eurodiet

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eurodiet treatment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
The "Dr. Fedon Lindbergs Vektcoach" Treatment
Intervention Description
Diet and lifestyle treatment
Primary Outcome Measure Information:
Title
Body weight/composition
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Hormonal profile
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pål T Jåbekk, M.Sc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arne T Høstmark, Ph.D/Dr.Med
Organizational Affiliation
Unaffiliated/ Study supervisor
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Fedon Lindbergs Klinikk
City
Oslo
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs