- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01476436
Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers
October 4, 2018 updated by: Kjetil Retterstøl, Oslo University Hospital
Low carbohydrate diet may influence the plasma lipid levels.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Fasting plasma lipids will be measured in healthy volunteer randomized to low carbohydrate diet or usual diet for a period
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Oslo, Norway
- Oslo University Hospital
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Oslo, Norway, 0424
- Oslo University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers
Exclusion criteria:
Any disease or use of prescriptional medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LCHF diet
Advice of a diet low in carbohydrate
|
Dietary advice
Other Names:
Dietary advice
Other Names:
|
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Active Comparator: Usual diet
Subjects shall continue to eat their usual daily diet with no low carbohydrate intervention
|
Dietary advice
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent change in mean LDL-cholesterol after intervention with low carbohydrate diet
Time Frame: From baseline to study end
|
From baseline to study end
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kjetil Retterstøl, MD PhD, University of Oslo, Faculty of Medicine, Institute of Basic Medical Sciences, Department of Nutrition
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
September 22, 2017
Study Completion (Actual)
September 22, 2017
Study Registration Dates
First Submitted
August 11, 2011
First Submitted That Met QC Criteria
November 17, 2011
First Posted (Estimate)
November 22, 2011
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 4, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK195276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.