search
Back to results

Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers

Primary Purpose

Overweight and Obesity, Type IIb Hyperlipidaemia, Hypercholesterolemia Aggravated

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Low carbohydrate dietary advice
Continue usual diet
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight and Obesity focused on measuring Cardio vascular risk factors

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers

Exclusion criteria:

Any disease or use of prescriptional medication

Sites / Locations

  • Oslo University Hospital
  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LCHF diet

Usual diet

Arm Description

Advice of a diet low in carbohydrate

Subjects shall continue to eat their usual daily diet with no low carbohydrate intervention

Outcomes

Primary Outcome Measures

Percent change in mean LDL-cholesterol after intervention with low carbohydrate diet

Secondary Outcome Measures

Full Information

First Posted
August 11, 2011
Last Updated
October 4, 2018
Sponsor
Oslo University Hospital
Collaborators
University of Oslo
search

1. Study Identification

Unique Protocol Identification Number
NCT01476436
Brief Title
Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers
Official Title
Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 22, 2017 (Actual)
Study Completion Date
September 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Low carbohydrate diet may influence the plasma lipid levels.
Detailed Description
Fasting plasma lipids will be measured in healthy volunteer randomized to low carbohydrate diet or usual diet for a period

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Type IIb Hyperlipidaemia, Hypercholesterolemia Aggravated
Keywords
Cardio vascular risk factors

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCHF diet
Arm Type
Experimental
Arm Description
Advice of a diet low in carbohydrate
Arm Title
Usual diet
Arm Type
Active Comparator
Arm Description
Subjects shall continue to eat their usual daily diet with no low carbohydrate intervention
Intervention Type
Other
Intervention Name(s)
Low carbohydrate dietary advice
Other Intervention Name(s)
Dietary advice
Intervention Description
Dietary advice
Intervention Type
Other
Intervention Name(s)
Continue usual diet
Other Intervention Name(s)
Lifestyle counseling to continue usual diet
Intervention Description
Dietary advice
Primary Outcome Measure Information:
Title
Percent change in mean LDL-cholesterol after intervention with low carbohydrate diet
Time Frame
From baseline to study end

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers Exclusion criteria: Any disease or use of prescriptional medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjetil Retterstøl, MD PhD
Organizational Affiliation
University of Oslo, Faculty of Medicine, Institute of Basic Medical Sciences, Department of Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.med.uio.no/imb/english/
Description
Homepage

Learn more about this trial

Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers

We'll reach out to this number within 24 hrs