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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion criteria:

Any disease or use of prescriptional medication

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Not yet recruiting
Oslo, Norway
Contact: Kjetil Retterstøl, MD, PhD    +47 22851521    kjetil.retterstol@medisin.uio.no   
Principal Investigator: Kjetil Retterstøl, MD PhD         
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         
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:
No publications provided

Responsible Party: Kjetil Retterstøl, Associate professor, MD PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01476436     History of Changes
Other Study ID Numbers: REK195276
Study First Received: August 11, 2011
Last Updated: April 10, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Cardio vascular risk factors

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Overweight
Body Weight
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014