Low Carbohydrate Diet - Effect on Plasma Lipids and Metab... | NCT01476436

Studies
Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers

NCT01476436

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Oct 9, 2018Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Overweight and Obesity
Type IIb Hyperlipidaemia
Hypercholesterolemia Aggravated

Interventions

Low carbohydrate dietary advice
Continue usual diet

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Sep 22, 2017Actual

Completion Date

Sep 22, 2017Actual

First Submitted Date

Aug 11, 2011

First Submission Date that Met QC Criteria

Nov 17, 2011

First Posted Date

Nov 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2018

Last Update Posted Date

Oct 9, 2018Actual

Name	Class
University of Oslo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LCHF diet	Experimental	Advice of a diet low in carbohydrate	Other: Low carbohydrate dietary advice Other: Continue usual diet
Usual diet	Active Comparator	Subjects shall continue to eat their usual daily diet with no low carbohydrate intervention	Other: Continue usual diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low carbohydrate dietary advice	Other	Dietary advice	LCHF diet	Dietary advice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change in mean LDL-cholesterol after intervention with low carbohydrate diet		From baseline to study end

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers

Exclusion criteria:

Any disease or use of prescriptional medication

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kjetil Retterstøl, MD PhD	University of Oslo, Faculty of Medicine, Institute of Basic Medical Sciences, Department of Nutrition	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		0424	Norway
Oslo University Hospital

Label	URL
Homepage	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity
D006938	Hyperlipoproteinemia Type II

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015596	Nutrition Assessment

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided