Effects of Limicol on LDL-cholesterol | NCT01354327

Studies
Effects of Limicol on LDL-cholesterol

NCT01354327

Sponsor

Lescuyer Laboratory

Status

Completed

Last Update Posted

May 16, 2011Estimated

Enrollment

47Actual

Phase

Not Applicable

Conditions

Hypercholesteremia

Interventions

Limicol
Placebo

Countries

France

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

May 2011

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

Dec 2008

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

May 13, 2011

First Submission Date that Met QC Criteria

May 13, 2011

First Posted Date

May 16, 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

May 13, 2011

Last Update Posted Date

May 16, 2011Estimated

Name	Class
CIC Hôpital de la Conception - Marseille	UNKNOWN
Aix Marseille Université	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The principal objective of this study is to investigate the effects of a novel food supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate hypercholesterolemia.

Detailed Description

Not provided

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

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Limicol	Experimental		Dietary Supplement: Limicol
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Limicol	Dietary Supplement	3 tablets / day during 4 months	Limicol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in blood LDL-cholesterol levels at 4 months		4 months

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in blood Vit. C, Vit. E, polyphenols and MDA levels at 4 months		4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

About 18 to 55 years (inclusive)
Subject has a stable weight for at least three months before the start of the study
Subject able and willing to comply with the protocol and agreeing to give their consent in writing
Subject affiliated with a social security scheme
Subject willing to be included in the national register of volunteers who lend themselves to biomedical research

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sébastien Peltier, PhD	Lescuyer Laboratory	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Morange		Marseille		13005	France

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided