Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers
This study is currently recruiting participants.
Verified April 2012 by Oslo University Hospital
Sponsor:
Oslo University Hospital
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
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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
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 Obesity Overweight Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Overnutrition Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013