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Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Kjetil Retterstøl, Oslo University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476436
First Posted: November 22, 2011
Last Update Posted: April 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Kjetil Retterstøl, Oslo University Hospital
  Purpose
Low carbohydrate diet may influence the plasma lipid levels.

Condition Intervention
Overweight and Obesity Type IIb Hyperlipidaemia Hypercholesterolemia Aggravated Other: Low carbohydrate dietary advice Other: Continue usual diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers

Further study details as provided by Kjetil Retterstøl, Oslo University Hospital:

Primary Outcome Measures:
  • Percent change in mean LDL-cholesterol after intervention with low carbohydrate diet [ Time Frame: From baseline to study end ]

Estimated Enrollment: 22
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low carbohydrate dietary advice
Advice of a diet low in carbohydrate
Other: Low carbohydrate dietary advice
Dietary advice
Other Name: Dietary advice
Other: Continue usual diet
Blood and urine samples every 3 weeks. Participants continue to eat usual diet with no change in level of physical activity
Other Name: Lifestyle counseling to continue usual diet
Active Comparator: Lifestyle counseling to continue usual diet
Subjects shall continue to eat their usual daily diet with no low carbohydrate intervention
Other: Continue usual diet
Blood and urine samples every 3 weeks. Participants continue to eat usual diet with no change in level of physical activity
Other Name: Lifestyle counseling to continue usual diet

Detailed Description:
Fasting plasma lipids will be measured in healthy volunteer randomized to low carbohydrate diet or usual diet for a period
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion criteria:

Any disease or use of prescriptional medication

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476436


Contacts
Contact: Kjetil Retterstøl, MD PhD +47 22851521 kjetil.retterstol@medisin.uio.no
Contact: Kirsten Holven, PhD +47-22851361 kirsten.holven@medisin.uio.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Kjetil Retterstøl, MD, PhD    +47 22851521    kjetil.retterstol@medisin.uio.no   
Contact: Kirsten Holven, PhD    +47-22851361    kirsten.holven@medisin.uio.no   
Principal Investigator: Kjetil Retterstøl, MD PhD         
Oslo University Hospital Not yet recruiting
Oslo, Norway
Contact: Kjetil Retterstøl, MD, PhD    +47 22851521    kjetil.retterstol@medisin.uio.no   
Principal Investigator: Kjetil Retterstøl, MD PhD         
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
Principal Investigator: Kjetil Retterstøl, MD PhD University of Oslo, Faculty of Medicine, Institute of Basic Medical Sciences, Department of Nutrition
  More Information

Additional Information:
Responsible Party: Kjetil Retterstøl, Associate professor, MD PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01476436     History of Changes
Other Study ID Numbers: REK195276
First Submitted: August 11, 2011
First Posted: November 22, 2011
Last Update Posted: April 11, 2012
Last Verified: April 2012

Keywords provided by Kjetil Retterstøl, Oslo University Hospital:
Cardio vascular risk factors

Additional relevant MeSH terms:
Overweight
Hypercholesterolemia
Hyperlipidemias
Hyperlipoproteinemias
Hyperlipidemia, Familial Combined
Body Weight
Signs and Symptoms
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn