OverweightNCT01235208
The Effect of the Treatment Program "Dr. Fedon Lindbergs Vektcoach" on Body Weight and Composition and Hormonal Profile
A study testing The "Dr. Fedon Lindbergs Vektcoach" Treatment in people with Overweight and Obesity, run by Eurodiet Scandinavia AS at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity, Metabolic Syndrome
- What is being tested?
- The "Dr. Fedon Lindbergs Vektcoach" Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI)>35
- BMI>27 + one risk factor for cardiovascular disease or metabolic syndrome
- >18 years
Who cannot join
- Medicinal treatment of thyroid disease
- Pregnancy or planned pregnancy
- Taking of diet pills like Xenical or Sibutramine
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Overweight, Obesity, Metabolic Syndrome
- Being tested
- The "Dr. Fedon Lindbergs Vektcoach" Treatment
- Keywords
- Overweight, Obesity, Metabolic syndrome, Diet, Carbohydrate, Low glycemic index, Eurodiet
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The "Dr. Fedon Lindbergs Vektcoach" TreatmentOther
Diet and lifestyle treatment
| Study group | Role | What they receive |
|---|---|---|
| Eurodiet treatment | Experimental | Not described Receives: Other: The "Dr. Fedon Lindbergs Vektcoach" Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight/composition
Measured: 7 months
Secondary outcomes (1)
Hormonal profile
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurodiet Scandinavia AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pål T Jåbekk, M.Sc, Principal investigatorArne T Høstmark, Ph.D/Dr.Med, Study director, Unaffiliated/ Study supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235208
- Sponsor's protocol ID
- EDstudy
- Status last verified
- Aug 2012
- First submitted
- 4 Nov 2010
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01235208
- Acronym / sponsor ID
- EDstudy
- Conditions
- Overweight, Obesity, Metabolic Syndrome
- Keywords
- Overweight, Obesity, Metabolic syndrome, Diet, Carbohydrate, Low glycemic index, Eurodiet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Eurodiet Scandinavia ASIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eurodiet treatment | Experimental | Other: The "Dr. Fedon Lindbergs Vektcoach" Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI)>35
- BMI>27 + one risk factor for cardiovascular disease or metabolic syndrome
- >18 years
Key exclusion criteria (3 listed)
- Medicinal treatment of thyroid disease
- Pregnancy or planned pregnancy
- Taking of diet pills like Xenical or Sibutramine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The "Dr. Fedon Lindbergs Vektcoach" TreatmentDiet and lifestyle treatment | Other | Eurodiet treatment |
Primary outcome
Body weight/composition
Time frame: 7 months
1 secondary outcome
Hormonal profile
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pål T Jåbekk, M.Sc principal investigator
Arne T Høstmark, Ph.D/Dr.Med study director
Unaffiliated/ Study supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The "Dr. Fedon Lindbergs Vektcoach" Treatment in people with Overweight and Obesity, run by Eurodiet Scandinavia AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight/composition (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012.