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Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Kjetil Retterstøl, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01476436
First received: August 11, 2011
Last updated: April 10, 2012
Last verified: April 2012

August 11, 2011
April 10, 2012
November 2011
November 2013   (final data collection date for primary outcome measure)
Percent change in mean LDL-cholesterol after intervention with low carbohydrate diet [ Time Frame: From baseline to study end ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01476436 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers
Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers

Low carbohydrate diet may influence the plasma lipid levels.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Overweight and Obesity
  • Type IIb Hyperlipidaemia
  • Hypercholesterolemia Aggravated
  • 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
  • Experimental: Low carbohydrate dietary advice
    Advice of a diet low in carbohydrate
    Interventions:
    • Other: Low carbohydrate dietary advice
    • Other: 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
    Intervention: Other: Continue usual diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
22
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers

Exclusion criteria:

Any disease or use of prescriptional medication

Both
18 Years and older
Yes
Contact: Kjetil Retterstøl, MD PhD +47 22851521 kjetil.retterstol@medisin.uio.no
Contact: Kirsten Holven, PhD +47-22851361 kirsten.holven@medisin.uio.no
Norway
 
NCT01476436
REK195276
No
Kjetil Retterstøl, Oslo University Hospital
Oslo University Hospital
University of Oslo
Principal Investigator: Kjetil Retterstøl, MD PhD University of Oslo, Faculty of Medicine, Institute of Basic Medical Sciences, Department of Nutrition
Oslo University Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP