NCT01235208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

1.8 years

First QC Date

November 4, 2010

Last Update Submit

August 14, 2012

Conditions

OverweightObesityMetabolic Syndrome

Keywords

OverweightObesityMetabolic syndromeDietCarbohydrateLow glycemic indexEurodiet

Outcome Measures

Primary Outcomes (1)

  • Body weight/composition

    7 months

Secondary Outcomes (1)

  • Hormonal profile

    7 months

Study Arms (1)

Eurodiet treatment

EXPERIMENTAL
Other: The "Dr. Fedon Lindbergs Vektcoach" Treatment

Interventions

The "Dr. Fedon Lindbergs Vektcoach" TreatmentOTHER

Diet and lifestyle treatment

Eurodiet treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index (BMI)\>35
  • BMI\>27 + one risk factor for cardiovascular disease or metabolic syndrome
  • \>18 years

You may not qualify if:

  • Medicinal treatment of thyroid disease
  • Pregnancy or planned pregnancy
  • Taking of diet pills like Xenical or Sibutramine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Fedon Lindbergs Klinikk

Oslo, Norway

Location

MeSH Terms

Conditions

OverweightObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Pål T Jåbekk, M.Sc

    PRINCIPAL INVESTIGATOR

  • Arne T Høstmark, Ph.D/Dr.Med

    Unaffiliated/ Study supervisor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 5, 2010

Study Start

October 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations

NO(1)